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OBJECTIVE: To evaluate the association of insulin injection adherence, smart insulin pen engagement, and glycemic control using real-world data from 16 countries from adults self-administering basal insulin degludec and bolus insulin with a smart insulin pen (NovoPen 6 or NovoPen Echo Plus) alongside continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS: Data were aggregated over 14-day periods. Treatment adherence was defined according to the number of missed basal and missed bolus insulin doses and smart pen engagement according to the number of days with data uploads. RESULTS: Data from 3,945 adults, including 25,157 14-day periods with ≥70% CGM coverage, were analyzed. On average, 0.2 basal and 6.0 bolus insulin doses were missed over 14 days. The estimated probability of missing at least one basal insulin dose over a 14-day period was 17.6% (95% CI 16.5, 18.7). Missing one basal or bolus insulin dose per 14 days was associated with a significant decrease in percentage of time with glucose levels in range (TIR) (3.9–10.0 mmol/L), of −2.8% (95% CI −3.7, −1.8) and −1.7% (−1.8, −1.6), respectively; therefore, missing two basal or four bolus doses would decrease TIR by >5%. Smart pen engagement was associated positively with glycemic outcomes. CONCLUSIONS: This combined analysis of real-world smart pen and CGM data showed that missing two basal or four bolus insulin doses over a 14-day period would be associated with a clinically relevant decrease in TIR. Smart insulin pens provide valuable insights into treatment injection behaviors. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We examined longitudinal associations between emotional distress (specifically, depressive symptoms and diabetes distress) and medication adherence in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing four glucose-lowering medications added to metformin in adults with relatively recent-onset type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The Emotional Distress Substudy assessed medication adherence, depressive symptoms, and diabetes distress in 1,739 GRADE participants via self-completed questionnaires administered biannually up to 3 years. We examined baseline depressive symptoms and diabetes distress as predictors of medication adherence over 36 months. Bidirectional visit-to-visit relationships were also examined. Treatment satisfaction, beliefs about medication, diabetes care self-efficacy, and perceived control over diabetes were evaluated as mediators of longitudinal associations. RESULTS: At baseline, mean ± SD age of participants (56% of whom were White, 17% Hispanic/Latino, 18% Black, and 66% male) was 58.0 ± 10.2 years, diabetes duration 4.2 ± 2.8 years, HbA1c 7.5% ± 0.5%, and medication adherence 89.9% ± 11.1%. Higher baseline depressive symptoms and diabetes distress were independently associated with lower adherence over 36 months (P < 0.001). Higher depressive symptoms and diabetes distress at one visit predicted lower adherence at the subsequent 6-month visit (P < 0.0001) but not vice versa. Treatment assignment did not moderate relationships. Patient-reported concerns about diabetes medications mediated the largest percentage (11.9%–15.5%) of the longitudinal link between emotional distress and adherence. CONCLUSIONS: Depressive symptoms and diabetes distress both predict lower adherence to glucose-lowering medications over time among adults with T2DM. Addressing emotional distress and concerns about anticipated negative effects of taking these treatments may be important to support diabetes treatment adherence. [ABSTRACT FROM AUTHOR]

Use of effective treatments and management programs is leading to longer survival of people with diabetes. This, in combination with obesity, is thus contributing to a rise in people living with more than one condition, known as multiple long-term conditions (MLTC or multimorbidity). MLTC is defined as the presence of two or more long-term conditions, with possible combinations of physical, infectious, or mental health conditions, where no one condition is considered as the index. These include a range of conditions such as cardiovascular diseases, cancer, chronic kidney disease, arthritis, depression, dementia, and severe mental health illnesses. MLTC has major implications for the individual such as poor quality of life, worse health outcomes, fragmented care, polypharmacy, poor treatment adherence, mortality, and a significant impact on health care services. MLTC is a challenge, where interventions for prevention and management are lacking a robust evidence base. The key research directions for diabetes and MLTC from a global perspective include system delivery and care coordination, lifestyle interventions and therapeutic interventions. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We sought to examine the mediating role of changes in depressive symptoms in the association between chronic hyperglycemia and longitudinal cognition in a sample of older adults with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: We conducted a longitudinal mediation analysis using structural equation modeling of observational data collected over 6 years from 2,155 participants with T2D (aged ≥51 years) in the U.S.-wide Health and Retirement Study. T2D was defined using self-reported diagnosis, and HbA1c was assessed at study baseline. Self-reported depressive symptoms were assessed at two time points 4 years apart. Episodic memory was measured using a list-learning test administered at three time points over 6 years. We adjusted for sociodemographics, chronic health comorbidities, medication adherence, study enrollment year, and prior years' depressive symptoms and memory scores. RESULTS: At baseline, participants' mean age was 69.4 (SD = 9.1), mean HbA1c was 7.2% (SD = 1.4%), 55.0% were women, 19.3% were non-Latinx Black, and 14.0% were Latinx. Higher baseline levels of HbA1c were associated with increases in depressive symptoms over 4 years, which, in turn, were associated with poorer memory 2 years later. Depressive symptoms accounted for 19% of the longitudinal effect of HbA1c on memory over the 6-year period. Sensitivity analyses ruled out alternative directions of associations. CONCLUSIONS: Incident elevations in depressive symptoms mediated the longitudinal association between hyperglycemia and 6-year episodic memory scores. For older adults with T2D, interventions to prevent HbA1c-related incident depressive symptoms may be beneficial in reducing the neurotoxic effects of chronic hyperglycemia on cognition. [ABSTRACT FROM AUTHOR]

Objective: We aimed to understand the factors associated with sodium-glucose cotransporter 2 inhibitor (SGLT2i) adherence and longitudinal adherence trajectories in older adults with type 2 diabetes.Research Design and Methods: Using Medicare claims data (April 2013-December 2017), we identified 83,675 new SGLT2i users ≥66 years old with type 2 diabetes. We measured SGLT2i adherence as the proportion of days covered (PDC) during the first year of SGLT2i therapy. We used linear regression to assess the association between baseline covariates and PDC. Then we used group-based trajectory modeling to identify distinct longitudinal SGLT2i adherence groups and used a multivariable logistic regression model to examine the association between baseline covariates and membership in these adherence groups.Results: Unadjusted mean PDC was 63%. Previous adherence to statins had the strongest positive association with PDC (regression coefficient 6.00% [95% CI 5.50, 6.50]), whereas female sex (-5.51% [-6.02, -5.00]), and Black race/ethnicity (-5.06% [-6.03, -4.09]) had the strongest negative association. We identified three adherence trajectory groups: low (23% of patients, mean PDC 17%), moderate (32%, mean PDC 50%), and high (45%, mean PDC 96%) adherence. More patients in the high adherence group were previously adherent to statins (odds ratio 1.43 [95% CI 1.39, 1.48]), and more women (1.28 [1.23, 1.32]) and Black patients (1.31 [1.23, 1.40]) were in the low adherence group.Conclusions: In a large population of older patients with type 2 diabetes, 45% were highly adherent during the first year of SGLT2i treatment. Female sex and Black race/ethnicity were most strongly associated with low adherence. [ABSTRACT FROM AUTHOR]

Objective: To assess adherence to the three main drug classes in real-world patients with type 2 diabetes using biochemical urine testing, and to determine the association of nonadherence with baseline demographics, treatment targets, and complications.Research Design and Methods: Analyses were performed of baseline data on 457 patients in the DIAbetes and LifEstyle Cohort Twente (DIALECT) study. Adherence to oral antidiabetics (OADs), antihypertensives, and statins was determined by analyzing baseline urine samples using liquid chromatography-tandem mass spectrometry. Primary outcomes were microvascular and macrovascular complications and treatment targets of LDL cholesterol, HbA1c, and blood pressure. These were assessed cross-sectionally at baseline.Results: Overall, 89.3% of patients were identified as adherent. Adherence rates to OADs, antihypertensives, and statins were 95.7%, 92.0%, and 95.5%, respectively. The prevalence of microvascular (81.6% vs. 66.2%; P = 0.029) and macrovascular complications (55.1% vs. 37.0%; P = 0.014) was significantly higher in nonadherent patients. The percentage of patients who reached an LDL cholesterol target of ≤2.5 mmol/L was lower (67.4% vs. 81.1%; P = 0.029) in nonadherent patients. Binary logistic regression indicated that higher BMI, current smoking, elevated serum LDL cholesterol, high HbA1c, presence of diabetic kidney disease, and presence of macrovascular disease were associated with nonadherence.Conclusions: Although medication adherence of real-world type 2 diabetes patients managed in specialist care was relatively high, the prevalence of microvascular and macrovascular complications was significantly higher in nonadherent patients, and treatment targets were reached less frequently. This emphasizes the importance of objective detection and tailored interventions to improve adherence. [ABSTRACT FROM AUTHOR]

Objective: Text messaging interventions have high potential for scalability and for reductions in health disparities. However, more rigorous, long-term trials are needed. We examined the long-term efficacy and mechanisms of a tailored text messaging intervention.Research Design and Methods: Adults with type 2 diabetes participated in a parallel-groups, 15-month randomized controlled trial and were assigned to receive Rapid Education/Encouragement and Communications for Health (REACH) for 12 months or control. REACH included interactive texts and tailored texts addressing medication adherence and nontailored texts supporting other self-care behaviors. Outcomes included hemoglobin A1c (HbA1c), diabetes medication adherence, self-care, and self-efficacy.Results: Participants (N = 506) were approximately half racial/ethnic minorities, and half were underinsured, had annual household incomes <$35,000, and had a high school education or less; 11% were homeless. Average baseline HbA1c was 8.6% ± 1.8%; 70.0 ± 19.7 mmol/mol) with n = 219 having HbA1c ≥8.5% (69 mmol/mol). Half were prescribed insulin. Retention was over 90%. Median response rate to interactive texts was 91% (interquartile range 75%, 97%). The treatment effect on HbA1c at 6 months (-0.31%; 95% CI -0.61%, -0.02%) was greater among those with baseline HbA1c ≥8.5% (-0.74%; 95% CI -1.26%, -0.23%), and there was no evidence of effect modification by race/ethnicity or socioeconomic disadvantage. REACH improved medication adherence and diet through 12 months and self-efficacy through 6 months. Treatment effects were not significant for any outcome at 15 months. REACH reduced barriers to adherence, but barrier reduction did not mediate outcome improvements.Conclusions: REACH engaged at-risk patients in diabetes self-management and improved short-term HbA1c. More than texts alone may be needed to sustain the effects. [ABSTRACT FROM AUTHOR]

Objective: Geographic and racial/ethnic disparities related to diabetes control and treatment have not previously been examined at the national level.Research Design and Methods: A retrospective cohort study was conducted in a national cohort of 1,140,634 veterans with diabetes, defined as two or more diabetes ICD-9 codes (250.xx) across inpatient and outpatient records. Main exposures of interest included 125 Veterans Administration Medical Center (VAMC) catchment areas as well as racial/ethnic group. The main outcome measure was HbA1c level dichotomized at ≥8.0% (≥64 mmol/mol).Results: After adjustment for age, sex, racial/ethnic group, service-connected disability, marital status, and the van Walraven Elixhauser comorbidity score, the prevalence of uncontrolled diabetes varied by VAMC catchment area, with values ranging from 19.1% to 29.2%. Moreover, these differences largely persisted after further adjusting for medication use and adherence as well as utilization and access metrics. Racial/ethnic differences in diabetes control were also noted. In our final models, compared with non-Hispanic Whites, non-Hispanic Blacks (odds ratio 1.11 [95% credible interval 1.09-1.14]) and Hispanics (1.36 [1.09-1.14]) had a higher odds of uncontrolled HBA1c level.Conclusions: In a national cohort of veterans with diabetes, we found geographic as well as racial/ethnic differences in diabetes control rates that were not explained by adjustment for demographics, comorbidity burden, use or type of diabetes medication, health care utilization, access metrics, or medication adherence. Moreover, disparities in suboptimal control appeared consistent across most, but not all, VAMC catchment areas, with non-Hispanic Black and Hispanic veterans having a higher odds of suboptimal diabetes control than non-Hispanic White veterans. [ABSTRACT FROM AUTHOR]

Objective: Suboptimal adherence to insulin treatment is a main issue in adolescents with type 1 diabetes. However, to date, there are no available data on adherence to adjunct noninsulin medications in this population. Our aim was to assess adherence to ACE inhibitors and statins and explore potential determinants in adolescents with type 1 diabetes.Research Design and Methods: There were 443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs-an ACE inhibitor and a statin-as well as combinations of both or placebo for 2-4 years. Adherence was assessed every 3 months with the Medication Event Monitoring System (MEMS) and pill count.Results: Median adherence during the trial was 80.2% (interquartile range 63.6-91.8) based on MEMS and 85.7% (72.4-92.9) for pill count. Adherence based on MEMS and pill count dropped from 92.9% and 96.3%, respectively, at the first visit to 76.3% and 79.0% at the end of the trial. The percentage of study participants with adherence ≥75% declined from 84% to 53%. A good correlation was found between adherence based on MEMS and pill count (r = 0.82, P < 0.001). Factors associated with adherence were age, glycemic control, and country.Conclusions: We report an overall good adherence to ACE inhibitors and statins during a clinical trial, although there was a clear decline in adherence over time. Older age and suboptimal glycemic control at baseline predicted lower adherence during the trial, and, predictably, reduced adherence was more prevalent in subjects who subsequently dropped out. [ABSTRACT FROM AUTHOR]

Objective: Patient adherence is a challenge in offloading diabetic foot ulcers (DFUs) with removable cast walkers (RCWs). The size and weight of an RCW, changes to gait, and imposed limb-length discrepancies may all discourage adherence. This study sought to determine whether RCW size and provision of a contralateral limb lift affected users' comfort and gait.Research Design and Methods: Twenty-five individuals at risk for DFUs completed several 20-m walking trials under five footwear conditions: bilateral standardized shoes, a knee-high RCW with shoe with or without an external shoe lift contralaterally, and an ankle-high RCW with shoe with or without an external shoe lift contralaterally. Perceived comfort ratings were assessed through the use of visual analog scales. Spatial and temporal parameters of gait were captured by an instrumented walkway, and plantar pressure was measured and recorded using pedobarographic insoles.Results: The bilateral shoes condition was reported to be most comfortable; both RCW conditions without the lift were significantly less comfortable (P < 0.01). In contrast to the ankle-high RCW, the knee-high RCW resulted in significantly slower walking (5.6%; P < 0.01) but greater offloading in multiple forefoot regions of the offloaded foot (6.8-8.1%; P < 0.01). Use of the contralateral shoe lift resulted in significantly less variability in walking velocity (52.8%; P < 0.01) and reduced stance time for the offloaded foot (2.6%; P = 0.01), but it also reduced offloading in multiple forefoot regions of the offloaded foot (3.7-6.0%; P < 0.01).Conclusions: Improved comfort and gait were associated with the ankle-high RCW and contralateral limb lift. Providing this combination to patients with active DFUs may increase offloading adherence and subsequently improve healing. [ABSTRACT FROM AUTHOR]

Objective: A previous study suggests an association between poor medication adherence and excess mortality in chronic disease. The purpose of this study was to assess the association between medication adherence and risk of cardiovascular disease (CVD), all-cause mortality, and hospitalization in type 2 diabetes.Research Design and Methods: We conducted an electronic search on many electronic databases from inception to 27 April 2016. We selected randomized controlled trials and case-control and cohort studies reporting on CVD, all-cause mortality, or hospitalization outcomes by adherence in adults with type 2 diabetes. Two reviewers independently screened for eligible studies and extracted outcome data. Pooled relative risks (RRs) were calculated using a random-effects meta-analysis; risk of bias in each of the included studies was assessed using the GRADE approach.Results: Eight observational studies were included (n = 318,125). The mean rate of poor adherence was 37.8% (95% CI 37.6-38.0). Adjusted estimates were provided by five studies only. The RRs of good (≥80%) versus poor adherence to medication were 0.72 (95% CI 0.62-0.82, I2 = 0%, three studies) for all-cause mortality and 0.90 (0.87-0.94, I2 = 63%, seven studies) for hospitalization. No evidence of small study bias was observed. Only one study reported CVD outcomes by adherence.Conclusions: We identified no trials reporting on outcomes by adherence, suggesting a systematic failure to include this information. Pooled estimates from available observational studies suggest that good medication adherence is associated with reduced risk of all-cause mortality and hospitalization in people with type 2 diabetes, although bias cannot be excluded as an explanation for these findings. [ABSTRACT FROM AUTHOR]

Objective: The American Diabetes Association recommends metformin as first-line therapy for type 2 diabetes. However, nonadherence to antihyperglycemic medication is common, and a clinician could confuse nonadherence with pharmacologic failure, potentially leading to premature prescribing of second-line therapies. We measured metformin use prior to second-line therapy initialization.Research Design and Methods: This retrospective cross-sectional study used unidentifiable member claims data from individuals covered from 2010 to 2015 by Aetna, a U.S. health benefits company. Beneficiaries with two physician claims or one hospitalization with a type 2 diabetes diagnosis were included. Recommended use of metformin was measured by the proportion of days covered over 60 days. Through sensitivity analysis, we varied estimates of the percentage of beneficiaries who used low-cost generic prescription medication programs.Results: A total of 52,544 individuals with type 2 diabetes were eligible. Of 22,956 patients given second-line treatment, only 1,875 (8.2%) had evidence of recommended use of metformin in the prior 60 days, and 6,441 (28.0%) had no prior claims evidence of having taken metformin. At the top range of sensitivity, only 49.5% patients could have had recommended use. Patients were more likely to be given an additional second-line antihyperglycemic medication or insulin if they were given their initial second-line medication without evidence of recommended use of metformin (P < 0.001).Conclusions: Despite published guidelines, second-line therapy often is initiated without evidence of recommended use of first-line therapy. Apparent treatment failures, which may in fact be attributable to nonadherence to guidelines, are common. Point-of-care and population-level processes are needed to monitor and improve guideline adherence. [ABSTRACT FROM AUTHOR]

Despite U.S. Food and Drug Administration (FDA) approval of over 40 new treatment options for type 2 diabetes since 2005, the latest data from the National Health and Nutrition Examination Survey show that the proportion of patients achieving glycated hemoglobin (HbA1c) <7.0% (<53 mmol/mol) remains around 50%, with a negligible decline between the periods 2003-2006 and 2011-2014. The Healthcare Effectiveness Data and Information Set reports even more alarming rates, with only about 40% and 30% of patients achieving HbA1c <7.0% (<53 mmol/mol) in the commercially insured (HMO) and Medicaid populations, respectively, again with virtually no change over the past decade. A recent retrospective cohort study using a large U.S. claims database explored why clinical outcomes are not keeping pace with the availability of new treatment options. The study found that HbA1c reductions fell far short of those reported in randomized clinical trials (RCTs), with poor medication adherence emerging as the key driver behind the disconnect. In this Perspective, we examine the implications of these findings in conjunction with other data to highlight the discrepancy between RCT findings and the real world, all pointing toward the underrealized promise of FDA-approved therapies and the critical importance of medication adherence. While poor medication adherence is not a new issue, it has yet to be effectively addressed in clinical practice-often, we suspect, because it goes unrecognized. To support the busy health care professional, innovative approaches are sorely needed. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to estimate and explain the gap between clinical efficacy and real-world (RW) effectiveness of type 2 diabetes medications.Research Design and Methods: This mixed-methods quasi-experimental study used retrospective claims (Optum/Humedica) to compare the change in HbA1c of RW patients with type 2 diabetes 12 months after starting a glucagon-like peptide 1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase 4 (DPP-4) inhibitor with published findings from randomized controlled trials (RCTs) evaluating these drugs. Selected RW patients were similar to RCT patients, and regression analysis was used in the RW data to adjust for differences between poorly adherent and adherent patients to explain why RCT and RW findings may differ.Results: RW patients initiating a GLP-1 RA (n = 221) or a DPP-4 (n = 652) experienced smaller reductions in HbA1c (GLP-1 RA: -0.52% [-6 mmol/mol], DPP-4: -0.51% [-6 mmol/mol])than reported in RCTs (-1.30% [-14 mmol/mol] from seven GLP-1 RA RCTs, n = 2,600; -0.68% [-8 mmol/mol] from four DPP-4 RCTs, n = 1,889). Baseline HbA1c, additional medications, and adherence were significant explanatory factors in the RW HbA1c change. Modeled estimates of RCT efficacy (-1.04% GLP-1 RA [-12 mmol/mol], -0.69% DPP-4 [-8 mmol/mol]) were within the RCTs' reported range (GLP-1 RA: -0.84% to -1.60% [-9 to -18 mmol/mol], DPP-4: -0.47% to -0.90% [-5 to -10 mmol/mol]). Poor medication adherence accounted for approximately three-fourths of the gap between RW and expected RCT results (gap = 0.51% [6 mmol/mol] GLP-1 RA; 0.18% [3 mmol/mol] DPP-4).Conclusions: Poor medication adherence is primarily why RW effectiveness is significantly less than RCT efficacy, suggesting an urgent need to effectively address adherence among patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the compliance with self-monitoring of blood glucose (SMBG) and the reliability of diabetes logbooks in women with gestational diabetes mellitus (GDM), as well as the associated determinants and outcomes.Research Design and Methods: We prospectively selected French-speaking women with newly diagnosed GDM who had been referred to our diabetes management program and understood SMBG principles. At the next follow-up visit, we collected SMBG results from glucose meters and logbooks. We analyzed pregnancy outcomes.Results: Data were analyzed over 13 ± 3 days in 91 women. Only 61.5% had performed ≥80% of the required tests. Poor compliance was associated with a family history of diabetes, social deprivation, and non-European origin. The average time between pre- and postprandial tests was 141 ± 20 min, with 46.5% of women performing ≥80% of postprandial measurements 100-140 min after meals. Inadequate timing was associated with ethnicity and higher HbA1c at baseline. A total of 23.1% of women had <90% matched values in diary and meter memory, and a poor concordance was associated with a family history of diabetes. Poor adherence was associated with more preeclampsia (12.2 vs. 1.9%, P = 0.049), and inadequate postprandial test timing with a higher HbA1c at delivery (5.3 ± 0.4 vs. 5.0 ± 0.3% [34 ± 2 vs. 31 ± 2 mmol/mol], P < 0.01), despite more frequent insulin therapy.Conclusions: Although women with GDM are considered to be highly motivated, SMBG adherence and reliability are of concern and may be associated with poor gestational prognosis, suggesting that caregivers should systematically check the glucose meter memory to improve GDM management. [ABSTRACT FROM AUTHOR]

Objective: We conducted comprehensive assessments of emotional distress to examine relations with diabetes medication adherence over time.Research Design and Methods: Ethnically and socioeconomically diverse adults treated for type 2 diabetes completed validated self-reports (SRs) for diabetes distress and depression, were administered semistructured depression interviews, and provided blood samples for A1C. Medication adherence among 104 participants was electronically monitored (EM) over the subsequent 3 months; validated SRs of medication adherence were also obtained. Hierarchical linear regression evaluated independent effects of diabetes distress and depression on adherence.Results: Mean ± SD 3-month medication adherence was 76.1% ± 25.7% for EM and 83.7% ± 21.9% for SR. Higher levels of SR (P < 0.001) and interview-based (P < 0.05) depressive symptom severity (P < 0.05) and diabetes-related distress (P < 0.01) showed a significant bivariate association with EM and SR nonadherence. Regression models showed baseline diabetes distress was a significant independent predictor of EM (β = -0.29; P = 0.001) and SR adherence (β = -0.24; P < 0.02) at follow-up. SR depression was an independent predictor of EM and SR adherence and reduced the effects of diabetes distress to nonsignificance. Subsequent models indicated this effect was driven by somatic rather than cognitive-affective symptoms of depression. Results were consistent but weaker for interview-based depressive symptoms.Conclusions: Findings support diabetes-related distress and depression symptom severity as risk factors for type 2 diabetes medication nonadherence. Somatic symptoms captured by depression measures, but not cognitive-affective symptoms, independently predict nonadherence and should be further investigated as a potential link between emotional distress and nonadherence. [ABSTRACT FROM AUTHOR]

Objective: To identify factors that predict medication adherence and to examine relationships among adherence, glycemic control, and indices of insulin action in TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth).Research Design and Methods: A total of 699 youth 10-17 years old with recent-onset type 2 diabetes and ≥80% adherence to metformin therapy for ≥8 weeks during a run-in period were randomized to receive one of three treatments. Participants took two study pills twice daily. Adherence was calculated by pill count from blister packs returned at visits. High adherence was defined as taking ≥80% of medication; low adherence was defined as taking <80% of medication. Depressive symptoms, insulin sensitivity (1/fasting insulin), insulinogenic index, and oral disposition index (oDI) were measured. Survival analysis examined the relationship between medication adherence and loss of glycemic control. Generalized linear mixed models analyzed trends in adherence over time.Results: In this low socioeconomic cohort, high and low adherence did not differ by sex, age, family income, parental education, or treatment group. Adherence declined over time (72% high adherence at 2 months, 56% adherence at 48 months, P < 0.0001). A greater percentage of participants with low adherence had clinically significant depressive symptoms at baseline (18% vs. 12%, P = 0.0415). No adherence threshold predicted the loss of glycemic control. Longitudinally, participants with high adherence had significantly greater insulin sensitivity and oDI than those with low adherence.Conclusions: In the cohort, the presence of baseline clinically significant depressive symptoms was associated with subsequent lower adherence. Medication adherence was positively associated with insulin sensitivity and oDI, but, because of disease progression, adherence did not predict long-term treatment success. [ABSTRACT FROM AUTHOR]

Objective: Studies indicate that off-loading adherence is low in patients with diabetic foot ulcers (DFUs), which may subsequently delay healing. However, there is little empirical evidence for this relationship or the factors that influence adherence.Research Design and Methods: This prospective, multicenter, international study of 79 (46 from the U.K. and 33 the U.S.) persons with type 2 diabetes and plantar DFUs assessed the association between off-loading adherence and DFU healing over a 6-week period. Additionally, potential demographic, disease, and psychological determinants of adherence were examined. DFUs were off-loaded with a removable device (77% a removable cast walker). Off-loading adherence was assessed objectively by activity monitors. Patient-reported measures included Hospital Anxiety and Depression Scale (HADS), Neuropathy and Foot Ulcer Quality of Life (NeuroQoL) instrument, and Revised Illness Perception Questionnaire (IPQ-R).Results: Off-loading adherence was monitored for 35 ± 10 days, and devices were used during 59 ± 22% of subjects' activity. In multivariate analyses, smaller baseline DFU size, U.K. study site, and better off-loading adherence predicted smaller DFU size at 6 weeks (P < 0.05). Better off-loading adherence was, in turn, predicted by larger and more severe baseline DFUs, more severe neuropathy, and NeuroQoL foot pain (P < 0.05). In contrast, greater NeuroQoL postural instability predicted worse off-loading adherence (P < 0.001). HADS and IPQ-R measures were not significantly associated with off-loading adherence.Conclusions: Off-loading adherence is associated with the amount of DFU healing that occurs, while postural instability is a powerful predictor of nonadherence. Clinicians should take this neuropathic symptom into consideration when selecting an off-loading device, as off-loading-induced postural instability may further contribute to nonadherence. [ABSTRACT FROM AUTHOR]

Objective: The current study examined the utility of a new self-report questionnaire, the Illness Identity Questionnaire (IIQ), which assesses the concept of illness identity, or the degree to which type 1 diabetes is integrated into one's identity. Four illness identity dimensions (engulfment, rejection, acceptance, and enrichment) were validated in adolescents and emerging adults with type 1 diabetes. Associations with psychological and diabetes-specific functioning were assessed.Research Design and Methods: A sample of 575 adolescents and emerging adults (14-25 years of age) with type 1 diabetes completed questionnaires on illness identity, psychological functioning, diabetes-related problems, and treatment adherence. Physicians were contacted to collect HbA1c values from patients' medical records. Confirmatory factor analysis (CFA) was conducted to validate the IIQ. Path analysis with structural equation modeling was used to examine associations between illness identity and psychological and diabetes-specific functioning.Results: CFA indicated that the IIQ has a clear factor structure, meaningfully differentiating four illness identity dimensions. Rejection was related to worse treatment adherence and higher HbA1c values. Engulfment was related to less adaptive psychological functioning and more diabetes-related problems. Acceptance was related to more adaptive psychological functioning, fewer diabetes-related problems, and better treatment adherence. Enrichment was related to more adaptive psychological functioning.Conclusions: The present findings underscore the importance of the concept of illness identity. A valid and reliable measure, the IIQ, is introduced to measure four illness identity dimensions in individuals with type 1 diabetes. These four illness identity dimensions were uniquely related to psychological and diabetes-specific functioning. [ABSTRACT FROM AUTHOR]

Objective: The impact of taking oral glucose-lowering medicines intermittently, rather than as recommended, is unclear. We conducted a retrospective cohort study using community-acquired U.K. clinical data (Clinical Practice Research Database [CPRD] and GoDARTS database) to examine the prevalence of nonadherence to treatment for type 2 diabetes and investigate its potential impact on HbA1c reduction stratified by type of glucose-lowering medication.Research Design and Methods: Data were extracted for patients treated between 2004 and 2014 who were newly prescribed metformin, sulfonylurea, thiazolidinedione, or dipeptidyl peptidase 4 inhibitors and who continued to obtain prescriptions over 1 year. Cohorts were defined by prescribed medication type, and good adherence was defined as a medication possession ratio ≥0.8. Linear regression was used to determine potential associations between adherence and 1-year baseline-adjusted HbA1c reduction.Results: In CPRD and GoDARTS, 13% and 15% of patients, respectively, were nonadherent. Proportions of nonadherent patients varied by the oral glucose-lowering treatment prescribed (range 8.6% [thiazolidinedione] to 18.8% [metformin]). Nonadherent, compared with adherent, patients had a smaller HbA1c reduction (0.4% [4.4 mmol/mol] and 0.46% [5.0 mmol/mol] for CPRD and GoDARTs, respectively). Difference in HbA1c response for adherent compared with nonadherent patients varied by drug (range 0.38% [4.1 mmol/mol] to 0.75% [8.2 mmol/mol] lower in adherent group). Decreasing levels of adherence were consistently associated with a smaller reduction in HbA1c.Conclusions: Reduced medication adherence for commonly used glucose-lowering therapies among patients persisting with treatment is associated with smaller HbA1c reductions compared with those taking treatment as recommended. Differences observed in HbA1c responses to glucose-lowering treatments may be explained in part by their intermittent use. [ABSTRACT FROM AUTHOR]

Objective: We evaluated pregnancy outcomes, maternal and fetal/neonatal, during the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study.Research Design and Methods: The TODAY study was a randomized controlled trial comparing three treatment options for youth with type 2 diabetes. Informed consent included the requirement for contraception, including abstinence; this was reinforced at each visit. Following informed consent, self-reported data related to the mother's prenatal care and delivery and the infant's health were retrospectively collected. When permitted, maternal medical records and infant birth records were reviewed.Results: Of the 452 enrolled female participants, 46 (10.2%) had 63 pregnancies. Despite continued emphasis on adequate contraception, only 4.8% of the pregnant participants reported using contraception prior to pregnancy. The mean age at first pregnancy was 18.4 years; the mean diabetes duration was 3.17 years. Seven pregnancies were electively terminated; three pregnancies had no data reported. Of the remaining 53 pregnancies, 5 (9.4%) resulted in early pregnancy loss, and 7 (13%) resulted in loss with inadequate pregnancy duration data. Two pregnancies ended in stillbirth, at 27 and 37 weeks, and 39 ended with a live-born infant. Of the live-born infants, six (15.4%) were preterm and eight (20.5%) had a major congenital anomaly.Conclusions: Despite diabetes-specific information recommending birth control and the avoidance of pregnancy, 10% of the study participants became pregnant. Pregnancies in youth with type 2 diabetes may be especially prone to result in congenital anomalies. Reasons for the high rate of congenital anomalies are uncertain, but may include poor metabolic control and extreme obesity. [ABSTRACT FROM AUTHOR]

Objective: Individuals with type 1 diabetes who restrict insulin to control weight are at high risk for diabetes-related complications and premature death. However, little is known about this behavior or how to effectively intervene. The aim of the current study was to identify predictors of insulin restriction in the natural environment that might inform new treatment directions.Research Design and Methods: Eighty-three adults with type 1 diabetes and a range of eating disorder symptomatology completed 3 days of ecological momentary assessment. Participants reported emotions, eating, and insulin dosing throughout the day using their cellular telephone. Linear mixed models were used to estimate the effects of heightened negative affect (e.g., anxiety) before eating and characteristics of the eating episode (e.g., eating a large amount of food) on the risk of insulin restriction.Results: Individuals who reported greater-than-average negative affect (general negative affect and negative affect specifically about diabetes) during the study period were more likely to restrict insulin. Momentary increases in anxiety/nervousness and guilt/disgust with self before eating (relative to an individual's typical level) further increased the odds of restricting insulin at the upcoming meal. Insulin restriction was more likely when individuals reported that they broke a dietary rule (e.g., "no desserts").Conclusions: Results suggest that insulin restriction might be decreased by helping patients with type 1 diabetes respond effectively to heightened negative affect (e.g., anxiety, guilt) and encouraging patients to take a less rigid, punitive approach to diabetes management. [ABSTRACT FROM AUTHOR]

OBJECTIVE The objective of this study was to compare the relative effectivenes of two modes of delivering Behavioral Family Systems Therapy for Diabetes (BFST-D) to improve adherence and glycemic control among adolescents with type 1 diabetes with suboptimal glycemic control (HbA1c ≥9.0% [≥74.9 mmol/mol]): face to face in clinic (Clinic) and Internet videoconferencing (Skype) conditions. RESEARCH DESIGN AND METHODS Adolescents aged 12 to 18 years and at least one adult caregiver were randomized to receive BFST-D via the Clinic or Skype condition. Participants completed up to 10 therapy sessions within a 12-week period. Changes in youth- and parent-reported adherence and glycemic control were compared before and after the intervention and at follow-up assessment. RESULTS Using an intent-to-treat analytic approach, no significant between-group differences were identified between the before, after, and follow-up assessments. Groups were collapsed to examine the overall effects of BFST-D on adherence and glycemic control. Results identified that statistically significant improvements in adherence and glycemic control occurred from before to after the intervention; improvements were maintained at 3-month follow-up. CONCLUSIONS Delivery of BFST-D via Internet-based videoconferencing is viable for addressing nonadherence and suboptimal glycemic control in adolescents with type 1 diabetes, potentially reducing important barriers to care for youth and families. [ABSTRACT FROM AUTHOR]

Objective: The American Heart Association's recommendations for optimal health, summarized in Life's Simple 7, have been associated with reduced risk of cardiovascular disease (CVD)-related end points, but no studies have examined the association of these goals with incident type 2 diabetes, which is associated with high risk for CVD. The purpose of this analysis was to examine the associations of Life's Simple 7 goals with incident diabetes among American Indians, a population at high risk of cardiometabolic diseases. Research Design and Methods: Strong Heart Family Study participants without diabetes (n = 1,639) at baseline and who participated in a follow-up examination were included in the analysis. Risk scores ranging from 0 to 7 were created using physical activity, diet, BMI, smoking, blood pressure, fasting glucose, and cholesterol metrics in accordance with Life's Simple 7 goals. Diabetes was defined using 2003 American Diabetes Association criteria, including use of insulin or oral antidiabetes medication or a follow-up fasting plasma glucose level ≥126 mg/dL. Generalized estimating equations were used to examine the association of risk scores with incident diabetes. Results: During a mean 5-year follow-up (range 4-8 years), we identified 210 cases of incident type 2 diabetes. Compared with participants who achieved 0-1 goals, those who achieved 2-3 or 4+ goals had lower odds of diabetes, with odds ratios = 0.40 (95% CI 0.29-0.56) and 0.11 (95% CI 0.05-0.21), respectively. Conclusions: The adoption of as few as two or three Life's Simple 7 goals is associated with a lower risk of diabetes. [ABSTRACT FROM AUTHOR]

OBJECTIVE Persons with serious mental illness (SMI) may benefit from collocation of medical and mental health healthcare professionals and services in attending to their chronic comorbid medical conditions. We evaluated and compared glucose control and diabetes medication adherence among patients with SMI who received collocated care to those not receiving collocated care (which we call usual care). RESEARCH DESIGN AND METHODS We performed a cross-sectional, observational cohort study of 363 veteran patients with type 2 diabetes and SMI who received care from one of three Veterans Affairs medical facilities: two sites that provided both collocated and usual care and one site that provided only usual care. Through a survey, laboratory tests, and medical records, we assessed patient characteristics, glucose control as measured by a current HbA1c, and adherence to diabetes medication as measured by the medication possession ration (MPR) and self-report. RESULTS In the sample, the mean HbA1c was 7.4% (57 mmol/mol), the mean MPR was 80%, and 51% reported perfect adherence to their diabetes medications. In both unadjusted and adjusted analyses, there were no differences in glucose control and medication adherence by collocation of care. Patients seen in collocated care tended to have better HbA1c levels (β = 20.149; P = 0.393) and MPR values (β = 0.34; P = 0.132) and worse self-reported adherence (odds ratio 0.71; P = 0.143), but these were not statistically significant. CONCLUSIONS In a population of veterans with comorbid diabetes and SMI, patients on average had good glucose control and medication adherence regardless of where they received primary care. [ABSTRACT FROM AUTHOR]

OBJECTIVE To investigate the relationship between adherence with statin therapy and the risk of developing diabetes. RESEARCH DESIGN AND METHODS The cohort comprised 115,709 residents of the Italian Lombardy region who were newly treated with statins during 2003 and 2004. Patients were followed from the index prescription until 2010. During this period, patients who began therapy with an antidiabetic agent or were hospitalized for a main diagnosis of type 2 diabetes were identified (outcome). Adherence was measured by the proportion of days covered (PDC) with statins (exposure). A proportional hazards model was fitted to estimate hazard ratios (HRs) and 95% CIs for the exposure-outcome association, after adjusting for several covariates. A set of sensitivity analyses was performed to account for sources of systematic uncertainty. RESULTS During follow-up, 11,154 cohort members experienced the outcome. Compared with patients with very-low adherence (PDC <25%), those with low (26-50%), intermediate (51-75%), and high (≥75%) adherence to statin therapy had HRs (95% CIs) of 1.12 (1.06-1.18), 1.22 (1.14-1.27), and 1.32 (1.26-1.39), respectively. CONCLUSIONS In a real-world setting, the risk of new-onset diabetes rises as adherence with statin therapy increases. Benefits of statins in reducing cardiovascular events clearly overwhelm the diabetes risk. [ABSTRACT FROM AUTHOR]

OBJECTIVE This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS Twenty MDI-treated individuals with T2D with HbA1c ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed. RESULTS Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance. CONCLUSIONS PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes. [ABSTRACT FROM AUTHOR]

OBJECTIVE Cross-sectional and longitudinal associations among regimen distress (RD), self-management, and glycemic control were undertaken to explore mechanisms of operation among these variables. RESEARCH DESIGN AND METHODS In a behavioral randomized control trial (RCT) to reduce RD, 392 adults with type 2 diabetes were assessed for RD, diet, exercise, medication adherence, and HbA1c at baseline and at 4 and 12 months. Associations among RD, self-management, and HbA1c were examined in cross-sectional analyses at baseline, in prospective analyses using baseline values to predict change over time, and in time-varying analyses. RESULTS At baseline, greater RD and poorer medication adherence were independently associated with higher HbA1c (P =0 . 0 5a n d P < 0.001, respectively), and greater RD was associated with poorer medication adherence (P = 0.03). No consistent pattern of significant prospective associations was found. Significant time-varying findings showed that decreases in RD were associated with improvements in medication adherence (P < 0.01), physical activity (P < 0.001), and HbA1c (P =0.02) over time following intervention. Changes in self-management were not associated with changes in HbA1c over time. CONCLUSIONS In the context of an RCT to reduce distress, RD, self-management, and HbA1c were interrelated in cross-sectional and time-varying analyses. Decreases in RD were associated with improvements in both self-management and HbA1c over 12 months. Findings point to the complex and likely multifaceted pathways of association among these key constructs, with results indicating significant linkages between RD and both self-management and glycemic control over time. [ABSTRACT FROM AUTHOR]

OBJECTIVE-Clamp studies have shown that the absorption and action of rapid-acting insulin are faster with injection by a jet injector than with administration by conventional pen. To determinewhether these pharmacokinetic changes also exist in patientswith diabetes and benefit postprandial glucose control, we compared the pharmacologic profiles of insulin administration by jet injection versus conventional insulin pen after a standardized meal in patients with type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS-In a randomized, double-blind, doubledummy crossover study, 12 patients with type 1 diabetes and 12 patients with type 2 diabetes received insulin aspart either by jet injection or by conventional pen, in both cases followed by a standardized meal. Blood was sampled for 6 h for determination of glucose and insulin levels to calculate pharmacologic profiles. RESULTS-Insulin administration by jet injection resulted in shorter time until peak plasma insulin level (51.3 ± 6.4 vs. 91.9 ± 10.2 min; P = 0.003) and reduced hyperglycemic burden during the first hour (154.3 ± 20.8 vs. 196.3 ± 18.4 mmol z min z L-1; P = 0.041) compared with conventional administration. Jet injection did not, however, significantly reduce the hyperglycemic burden during the 5-h period thereafter. Therewas no indication that the jet injector performed differently in patients with type 1 and type 2 diabetes. CONCLUSIONS-The considerably more rapid insulin absorption after administration by jet injector translated to a significant if modest decrease in postprandial hyperglycemia in patients with type 1 and type 2 diabetes. The improved early postprandial glucose control may specifically benefit patients who have difficulty in limiting postprandial glucose excursions. [ABSTRACT FROM AUTHOR]

OBJECTIVE--To assess the validity of self-report measures of diabetes medication adherence and evaluate the effect of depression on the validity of these reports. RESEARCH DESIGN AND METHODS--Adults with type 2 diabetes, treated with oral medications, completed a set of medication adherence self-reports that varied response scales and time frames, were administered structured clinical interviews for depression, and provided blood samples for HbA1c as part of a screening for an intervention study. A subsample of participants with HbA1c ≥7.0% and clinically significant depression received Medication Event Monitoring System (MEMS) bottle caps to record adherence. Analyses examined relationships between adherence measures and HbA1c and, in the subsample, MEMS. Moderated linear regression evaluated whether depression severity modified relationships with HbA1c. RESULTS--Participant (n = 170, 57% men, 81% white, mean HbA1c 8.3% [SD, 1.7]) adherence self-reports were significantly (r =20.18 to 20.28; P,0.03) associated with lower HbA1c. In the subsample (n = 88), all self-reports were significantly (r = 0.35 to 0.55; P ≤ 0.001) associated with MEMS-measured adherence. Depression significantly moderated the relationship between three of six self-reports and HbA1c; at high levels of depression, associations with HbA1c became nonsignificant. CONCLUSIONS--Results support the validity of easily administered self-reports for diabetes medication adherence. One-month, percentage-based ratings of adherence had the strongest associations with MEMS and HbA1c; those requiring the report of missed doses had weaker associations. One-week self-ratings and measures that require respondents to record the number of missed doses appear to be vulnerable to bias from depression severity. [ABSTRACT FROM AUTHOR]

OBJECTIVE - To assess the association of compliance with treatment (medication and clinic appointments) and all-cause mortality in people with insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS - Data were extracted from U.K. general practice records and included patients (N = 15,984) who had diagnostic codes indicative of type 2 diabetes or who had received a prescription for an oral antidiabetic agent and were treated with insulin. Records in the 30 months before the index date were inspected for clinical codes (recorded at consultation) indicating medication noncompliance or medical appointment nonattendance. Noncompliance was defined as missing more than one scheduled visit or having at least one provider code for not taking medications as prescribed. Relative survival post index date was compared by determining progression to all-cause mortality using Cox proportional hazards models. RESULTS - Those identified as clinic nonattenders were more likely to be smokers, younger, have higher HbA1c, and have more prior primary care contacts and greater morbidity (P<0.001). Those identified as medication noncompliers were more likely to be women (P= 0.001), smokers (P= 0.014), and have higher HbA1c, more prior primary care contacts, and greater morbidity (all P<0.001). After adjustment for confounding factors, medication noncompliance (hazard ratio 1.579 [95% CI 1.167-2.135]), clinic nonattendance of one or two missed appointments (1.163 [1.042-1.299]), and clinic nonattendance of greater than two missed appointments (1.605 [1.356-1.900]) were independent risk factors for all-cause mortality. CONCLUSIONS - Medication noncompliance and clinic nonattendance, assessed during routine care by primary care physicians or their staff, were independently associated with in- creased all-cause mortality in patients with type 2 diabetes receiving insulin. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To review interventions with adherence-promoting components and document their impact on glycemic control via meta-analysis. RESEARCH DESIGN AND METHODS -- Data from 15 studies that met the following criteria were subjected to meta-analysis: 1) randomized, controlled trial, 2) study sample included youth aged < 19 years, 3) youth had type 1 diabetes, 4) study reported results on glycemic control; and 5) study reported use of adherence- or self-management-promoting components. RESULTS -- The 15 studies included 997 youth with type 1 diabetes. The mean effect size for pre- to posttreatment change for the intervention versus control group comparison was 0.11 (95% CI -0.01 to 0.23). This is a small effect, demonstrating very modest improvements in glycemic control. However, analysis for the pre- to posttreatment effects for the intervention group alone did show significant variability [Q(14) = 33.11; P < 0.05]. Multicomponent interventions, those that targeted emotional, social, or family processes that facilitate diabetes management, were more potent than interventions just targeting a direct, behavioral process (e.g., increase in blood glucose monitoring frequency). CONCLUSIONS-- Interventions that focus on direct, behavioral processes and neglect emotional, social, and family processes are unlikely to have an impact on glycemic control; multicomponent interventions showed more robust effects on A1C. Future clinical research should focus on refining interventions and gathering more efficacy and effectiveness data on health outcomes of the pediatric patients treated with these interventions. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- The primary aim of the study was to investigate the relationship among executive functioning, diabetes treatment adherence, and glycemic control. RESEARCH DESIGN AND METHODS-- Two hundred and thirty-five children with type 1 diabetes and their primary caregivers were administered the Diabetes Self-Management Profile to assess treatment adherence. Executive functioning was measured using the Behavior Rating Inventory of Executive Functioning and glycemic control was based on A1C. RESULTS-- Structural equation modeling indicated that a model in which treatment adherence mediated the relationship between executive functioning and glycemic control best fit the data. All paths were significant at P < 0.01. CONCLUSIONS-- These results indicate that executive functioning skills (e.g., planning, problem-solving, organization, and working memory) were related to adherence, which was related to diabetes control. Executive functioning may be helpful to assess in ongoing clinical management of type 1 diabetes. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- The purpose of this study was to assess factors associated with patient frequency of intentionally skipping insulin injections. RESEARCH DESIGN AND METHODS -- Data were obtained through an Internet survey of 502 U.S. adults self-identified as taking insulin by injection to treat type 1 or type 2 diabetes. Multiple regression analysis assessed independent associations of various demographic, disease, and injection-specific factors with insulin omission. RESULTS -- Intentional insulin omission was reported by more than half of respondents; regular omission was reported by 20%. Significant independent risk factors for insulin omission were younger age, lower income and higher education, type 2 diabetes, not following a healthy diet, taking more daily injections, interference of injections with daily activities, and injection pain and embarrassment. Risk factors differed between type 1 and type 2 diabetic patients, with diet nonadherence more prominent in type 1 diabetes and age, education, income, pain, and embarrassment more prominent in type 2 diabetes. CONCLUSIONS -- Whereas most patients did not report regular intentional omission of insulin injections, a substantial number did. Our findings suggest that it is important to identify patients who intentionally omit insulin and be aware of the potential risk factors identified here. For patients who report injection-related problems (interference with daily activities, injection pain, and embarrassment), providers should consider recommending strategies and tools for addressing these problems to increase adherence to prescribed insulin regimens. This could improve clinical outcomes. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- In the face of financial constraints, diabetic patients may forgo prescribed medications, causing negative health effects. This study examined how cost and noncost factors are associated with patterns of cost-related nonadherence to medications (CRN). RESEARCH DESIGN AND METHODS -- This was a cross-sectional survey of patients using medications for both diabetes and chronic pain (n = 245). Patients reported their income, out-of-pocket medication costs, education level, depressive symptoms, and medication-related beliefs and whether they cut back because of cost on 1) both diabetes and pain medications, 2) diabetes medications only, 3) pain medications only, or 4) neither. Multinomial logistic regression was used to model patients' adjusted odds ratios (AORs) of falling into these four possible categories. RESULTS -- Of the patients, 9% cut back on medications for both conditions, 13% cut back on diabetes medications alone, and 9% cut back on pain medications alone. Income <20,000 USD (AOR = 5.7, P = 0.008) and monthly medication costs >50 USD (AOR = 3.9, P = 0.02) increased patients' odds of CRN for both conditions versus neither. Low-income patients also were more likely to selectively forgo pain medications (AOR = 9.1, P = 0.001) but not diabetes medications (AOR = 2.1, P = 0.12). More depressive symptoms (AOR = 1.6, P = 0.006) and negative medication-related beliefs (AOR = 1.7, P = 0.02) increased patients' odds of cutting back selectively on medications for diabetes but not pain. CONCLUSIONS-- Patients who forgo medications for both diabetes and chronic pain appear to be influenced primarily by economic pressures, whereas patients who cut back selectively on their diabetes treatments are influenced by their mood and medication beliefs. Our findings point toward more targeted strategies to assist diabetic patients who experience CRN. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To compare achievement of the American Diabetes Association diabetes care recommendations for U.S.- and foreign-born individuals with diabetes. RESEARCH DESIGN AND METHODS-- Using the 2001-2006 Medical Expenditure Panel Surveys, we report estimates for receipt of a cholesterol test, routine checkup, influenza vaccination, eye examination, dental checkup, foot examination, and two or more A1C tests in 1 year for foreign- (n = 1,272) and U.S.-born (n = 5,811) individuals aged ≥ 18 years. We define a dichotomous variable representing full compliance with the above examinations. We provide descriptive characteristics of the sample and use multivariable analysis for each procedure with random effects logit regression. RESULTS-- Compared with U.S.-born individuals with diabetes, foreign-born individuals are younger, have lower education levels and income, are more likely to have public or no insurance, and are less likely to have a usual source of care. With adjustment for all potential confounders, foreign-born individuals are less likely to report having had an influenza vaccination (odds ratio 0.51 [95% CI 0.31-0.71]) or to be compliant with any one of the seven recommendations (0.64 [0.34-0.95]). CONCLUSIONS-- These findings demonstrate that immigrants are less likely than U.S.-born individuals with diabetes to adhere to any one of seven diabetes care recommendations in general and, specifically, are less likely to report having received an influenza vaccination. Because immigrants are less likely to use health care, clinicians should take advantage of the office visit to effectively communicate to the patient the importance of receiving an influenza vaccination. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To estimate prevalence of, and factors associated with, sustained periods of hyperglycemia among patients with diabetes and factors associated with receipt of appropriate care once A1C values are persistently elevated. RESEARCH DESIGN AND METHODS -- Among patients initiating oral monotherapy (n = 5,070), Kaplan-Meier and Cox proportional hazards methods were used to estimate time to, and factors associated with, sustained hyperglycemia (defined by two A1cs >8% and no recent medication intensification), and among those experiencing sustained hyperglycemia, time to, and factors associated with, appropriate receipt of care (i.e., medication intensification or achieving A1C ≤ 7%). RESULTS -- Within 1 year, 8% experienced sustained hyperglycemia, with the proportion rising to 38% within 5 years. Patients using sulfonylurea had greater risk of hyperglycemia (hazard ratio [HR] 1.47 [95% CI 1.30-1.66]) compared with those initiating metformin. Risk increased with age (1.89 [1.27-2.831), was greater for African Americans (1.19 [1.05-1.361), and increased with A1C levels >7%. Among individuals with sustained hyperglycemia (n = 1,386), mean time to appropriate care was 9.7 months, with 25% not receiving appropriate care within 1 year. Shorter delays to appropriate care receipt were associated with increasing income (1.03 [1.00-1.07]), A1C >9% (1.38 [1.06-1.791) and >11% (1.65 [1.25-2.18]), increasing medication adherence (1.03 [1.01-1.041), and visits to primary care (4.22 [3.65-4.881) or endocrinology (3.89 [2.26-6.701). Longer delays were associated with increasing drug copayments (0.96 [0.93-0.98]). CONCLUSIONS -- Patients incurring sustained hyperglycemia are at risk of further delays in appropriate management. Barriers to appropriate care include prescription drug copayments, few physician contacts, and other factors that are likely amenable to intervention. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To evaluate ethnic differences in medication concerns (e.g., side effects and costs) that may contribute to ethnic differences in the adoption of and adherence to type 2 diabetes treatments. RESEARCH DESIGN AND METHODS -- We conducted face-to-face interviews from May 2004 to May 2006 with type 2 diabetic patients ≥18 years of age (N = 676; 25% Latino, 34% non-Hispanic Caucasian, and 41% non-Hispanic African American) attending Chicago-area clinics. Primary outcomes of interest were concerns regarding medications and willingness to take additional medications. RESULTS -- Latinos and African Americans had higher A1C levels than Caucasians (7.69 and 7.54% vs. 7.18%, respectively; P < 0.01). Latinos and African Americans were more likely than Caucasians to worry about drug side effects (66 and 49% vs. 39%, respectively) and medication dependency (65 and 52% vs. 39%, respectively; both P < 0.01). Ethnic minorities were a so more likely to report reluctance to adding medications to their regimen (Latino 12%, African American 18%, and Caucasian 7%; P < 0.01). In analyses adjusted for demographics, income, education, and diabetes duration, current report of pain/discomfort with pills (odds ratio 2.43 [95% CI 1.39-4.27]), concern regarding disruption of daily routine (1.97 [1.14-3.42]), and African American ethnicity (2.48 [1.32-4.69]) emerged as major predictors of expressed reluctance to adding medications. CONCLUSIONS -- Latinos and African Americans had significantly more concerns regarding the quality-of-life effects of diabetes-related medications than Caucasians. Whether these medication concerns contribute significantly to differences in treatment adoption and disparities in care deserves further exploration. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- The purpose of this study was to determine how patients' beliefs about anti-hyperglycemic and antihypertensive medications relate to medication underuse and health status. RESEARCH DESIGN AND METHODS -- In diabetic patients from an economically distressed region, we assessed perceived necessity and harmfulness for antihyperglycemic (n = 803) and antihypertensive (n = 573) medications, past year's medication underuse, AlC, systolic blood pressure (SBP), and diastolic blood pressure (DBP). RESULTS -- After correction for multiple analyses, multivariate models indicated that perceived need for antihyperglycemic medication was associated with being younger, being prescribed insulin, and being prescribed multiple medications. Concern about antihyperglycemic medications was associated with being younger, African American, dissatisfied with information received about medication, and of low health literacy. For antihypertensives, perceived necessity was associated with having numerous medical comorbidities and being dissatisfied with medication information; concern was associated with being younger, dissatisfied with information received about medication, and of low health literacy. Up to one-half of patients underused at least one of the types of medication; many of these patients attributed this underuse to cost. For both types of medications, concern was significantly associated with both cost-related and non-cost-related underuse, and antihypertensive concern was associated with higher SBP and DBP. CONCLUSIONS -- Even after adjustment for economic factors, patients who are younger, African American, or of low health literacy are especially concerned about medication harmfulness, which is in turn associated with medication underuse and higher blood pressure. To enhance adherence and outcomes, interventions should address patients' underlying concerns about potential adverse treatment effects and focus on both cultural factors and health literacy. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- The purpose of this study was to evaluate the effect of telephonic care management within a diabetes disease management program on adherence to treatment with hypoglycemic agents, ACE inhibitors (ACEIs), angiotensin receptor blockers (ARBs), statins, and recommended laboratory tests in a Medicaid population. RESEARCH DESIGN AND METHODS -- A total of 2,598 patients with diabetes enrolled for at least 2 years in Florida: A Healthy State (FAHS), a large Medicaid disease management program, who received individualized telephonic care management were selected if they were eligible for at least 12 months before and 12 months after beginning care management. Patients were matched one-to-one on all baseline characteristics to 2,598 control patients. The impact of care management on utilization and adherence rates for diabetes-related medications and tests was analyzed with the difference-in-difference estimator. RESULTS -- Changes in utilization were evaluated separately for those who were characterized as adherent to treatment at baseline ("users") and those who were not ("nonusers"). Both groups achieved significant improvement in adherence between baseline and follow-up. Nonusers increased their overall hypoglycemic use by 0.7 script (P < 0.001), by 0.7 script for ACEIs and statins (both P < 0.001), by 0.8 test for A1C (P < 0.001), and by 0.7 test for lipids (P < 0.001). Users increased hypoglycemic use by 1.5 scripts (P < 0.001) and insulin use by 0.9 script (P < 0.001). CONCLUSIONS -- The FAHS telephonic care management intervention effectively induced Medicaid patients with diabetes to begin treatment and improved adherence to oral hypoglycemic agents and recommended tests. It also substantially improved adherence among baseline insulin users. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- The purpose of this study was to examine medication adherence and other self-management practices as potential determinants of higher glycemic risk among black relative to white patients. RESEARCH DESIGN AND METHODS -- We used a retrospective, longitudinal repeated-measures design to model the contribution of medication adherence to black-white differences in A1C among type 2 diabetic patients at a large multispecialty group practice. We identified 1,806 adult (aged ≥18 at diagnosis) patients (467 black and 1,339 white) with newly initiated oral hypoglycemic therapy between 1 December 1994 and 31 December 2000. Race was identified using an electronic medical record and patient self-report. Baseline was defined as the 13 months preceding and included the month of therapy initiation. All patients were required to have at least 12 months of follow-up. RESULTS -- At initiation of therapy, black patients had higher average A1C values compared with whites (9.8 vs. 8.9, a difference of 0.88; P < 0.0001). Blacks had lower average medication adherence during the first year of therapy (72 vs. 78%; P < 0.0001). Although more frequent medication refills were associated with lower average A1C values, adjustment for adherence did not eliminate the black-white gap. CONCLUSIONS -- We found persistent racial differences in A1C that were not explained by differences in medication adherence. Our findings suggest that targeting medication adherence alone is unlikely to reduce disparities in glycemic control in this setting. Further research is needed to explore possible genetic and environmental determinants of higher A1C among blacks at diagnosis, which may represent a critical period for more intensive intervention. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- We examined the association between depression, measured as either a continuous symptom severity score or a clinical disorder variable, with self-care behaviors in type 2 diabetes. RESEARCH DESIGN AND METHODS -- We surveyed 879 type 2 diabetic patients from two primary care clinics using the Harvard Department of Psychiatry/National Depression Screening Day Scale (HANDS), the Summary of Diabetes Self-Care Activities, and self-reported medication adherence. RESULTS -- Of the patients, 19% met the criteria for probable major depression (HANDS score ±9), and an additional 66.5% reported at least some depressive symptoms. After controlling for covariates, patients with probable major depression reported significantly fewer days' adherent to diet, exercise, and glucose self-monitoring regimens (P < 0.01) and 2.3-fold increased odds of missing medication doses in the previous week (95% CI 1.5-3.6, P < 0.001) compared with all other respondents. Continuous depressive symptom severity scores were better predictors of nonadherence to diet, exercise, and medications than categorically defined probable major depression. Major depression was a better predictor of glucose monitoring. Among the two-thirds of patients not meeting the criteria for major depression (HANDS score < 9, n = 709), increasing HANDS scores were incrementally associated with poorer self-care behaviors (P < 0.01). CONCLUSIONS -- These findings challenge the conceptualization of depression as a categorical risk factor for nonadherence and suggest that even low levels of depressive symptomatology are associated with nonadherence to important aspects of diabetes self-care. Interventions aimed at alleviating depressive symptoms, which are quite common, could result in significant improvements in diabetes self-care. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- Glycemic control remains suboptimal despite the wide range of available medications. More effective medication prescription might result in better control. However, the process by which physicians, choose glucose-lowering medicines is poorly understood. We sought to study the means by which physicians choose medications for type 2 diabetic patients. RESEARCH DESIGN AND METHODS-- We surveyed 886 physician members of either the Society of General Internal Medicine (academic generalists, response rate 30%) or the American Diabetes Association (specialists, response rate 23%) currently managing patients with type 2 diabetes. Respondents weighed the importance of 15 patient, physician, and nonclinical factors when deciding which medications to prescribe for type 2 diabetic subjects at each of three management stages (initiation, use of second-line oral agents, and insulin). RESULTS -- Respondents reported using a median of five major considerations (interquartile range 4-6) at each stage. Frequently cited major considerations included overall assessment of the patient's health/comorbidity, A1C level, and patient's adherence behavior but not expert guidelines/hospital algorithms or patient age. For insulin initiation, academic generalists placed greater emphasis on patient adherence (76 vs. 60% of specialists, P < 0.001). These generalists also identified patient fear of injections (68%) and patient desire to prolong noninsulin therapy (68%) as major insulin barriers. Overall, qualitative factors (e.g., adherence, motivation, overall health assessment) were somewhat more highly considered than quantitative factors (e.g., A1C, age, weight) with mean aggregate scores of 7.3 vs. 6.9 on a scale of 0-10, P < 0.001. CONCLUSIONS-- The physicians in our survey considered a wide range of qualitative and quantitative factors when making medication choices for hyperglycemia management. The apparent complexity of the medication choice process contrasts with current evidence-based treatment guidelines. [ABSTRACT FROM AUTHOR]