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Background Healthcare disparities in the use of diabetes devices are particularly prevalent, especially given the high levels of health literacy and numeracy needed to understand their use. Methods To reduce this gap, we created lower literacy, English and Spanish, multicultural guides for insulin pen and pump use. Focus groups provided input, non-branded illustrations were designed, and simplified text was developed. The guides were implemented in our clinic for under-resourced individuals in East Los Angeles, California. Subjects given the low literacy guides participated in guide-driven individual and group education, and measures were administered at baseline, 6 and 12 months. Results 63 adults with T1D were included, and 43 (68%) completed all 12 months of the study. Initial HbA1c was 9.2 +/- 1.97 (SD) with no change over the study course (12-month A1C = 9.3 +/-1.92). However, participants showed significantly reduced psychological distress due to diabetes, increased diabetes knowledge, improved self-report of health, and a trend toward reduced depression. There was also a reduction in rates of DKA. There was also a reduction in rates of DKA. There was no change in rates of hypoglycemia, although there was an increase in fear of hypoglycemia. Conclusions Appropriately targeted teaching guides can be used to improve various patient-reported outcomes in people with T1D, specifically overall self-report of health, distress due to diabetes, and diabetes knowledge. Targeted teaching guides also achieved improvements in rates of DKA in T1D. While these results are encouraging, more work is needed to make a significant impact on glycemic control.

Healthcare disparities exist between those in more or less affluent communities. This is particularly true for diabetes devices, where intensive training and follow-up is needed. Materials are generally written at an 11th grade reading level. Further, illustrations generally show low ethnic diversity. To reduce this educational gap, we created lower literacy, English and Spanish, multicultural guides for insulin pen and pump use. Focus groups provided input, nonbranded illustrations were created, and the text was edited by the “Clear Language Group.” Methods: The guides were implemented in our clinic for underserved, largely Hispanic, individuals in East Los Angeles. 47 adults with T1D were included. Subjects were given the low literacy guides and participated in guide driven individual and group education. Measures administered at baseline and 12 months were assessed for normality and independent sample t-tests. A 2-sided alpha of 0.05 was used. Results: Initial A1C was 9.2 +/- 1.97 (SD) with no change over the study course (12-month A1C = 9.3 +/- 1.92). However, patients showed an improved overall self-report of health (p = 0.012), improvement in diabetes knowledge (Michigan Diabetes Knowledge Test, p=.004), a reduction in symptoms of depression (PHQ8, p=.042), and diabetes distress (Diabetes Distress Scale, T1D Redeem, p = 0.0123). Though no change in rates of hypoglycemia, a reduction in fear of hypoglycemia (Hypoglycemia Fear Scale, Fear sub-scale, P=0.025) was significant. Additionally, there was a reduction in rates of DKA (0.0108). Time in range was minimal, based on blinded CGM, at baseline (22.4%) and did not change at 12 months (24.0%). CGM data was only available on 25 patients due to patient reluctance to wear the device. Conclusions: Appropriately targeted teaching guides can be used to improve a variety of outcomes in people with T1D, including rates of DKA. However, more work is needed to make a significant impact on glycemic control. Disclosure A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. M.A. Walker: None. V.F. Ruelas: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

T1D management in older individuals can be difficult due to an increased risk for hypoglycemia and other co-morbidities. CGM can help lower rates of hypoglycemia; however, in practice, patient data is only reviewed at clinic visits, rather than in near real-time by the diabetes care team. This pilot study tested if patients could be remotely monitored daily through a CGM system (Dexcom G5/6) that communicated via smart phone to a Tidepool designed dashboard. Alerts were set for: ≥4 hours without CGM signal, ≥2 hours 54-70 mg/dl, and 15 mins Disclosure M.D. Harmel: Advisory Panel; Spouse/Partner; Abbott, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., MannKind Corporation, Merck & Co., Inc., Novo Nordisk Inc., Omada Health, Inc., OptumRx, Inc., Sanofi, Zafgen, Inc. Consultant; Self; MannKind Corporation. Research Support; Spouse/Partner; AstraZeneca, Dexcom, Inc., MannKind Corporation. Speaker's Bureau; Spouse/Partner; Novo Nordisk Inc. V.F. Ruelas: None. E.T. Nykaza: None. A.L. Peters: Advisory Panel; Self; Abbott, Becton, Dickinson and Company, Bigfoot Biomedical, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Livongo Health, MannKind Corporation, Medscape, Merck & Co., Inc., Omada Health, Inc., OptumRx, Inc., Sanofi US, Zafgen, Inc. Research Support; Self; AstraZeneca, Dexcom, Inc., Jaeb Center for Health Research, MannKind Corporation, National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Novo Nordisk Inc.

Purpose We identified and treated young adults with type 1 diabetes who had been lost to follow-up during their transfer from pediatric to adult care, comparing their clinical, psychosocial, and health care utilization outcomes to participants receiving continuous care (CC) throughout the transition to adult care. Methods Individuals in their last year of pediatric care (CC group, n = 51) and individuals lost to follow-up in the transfer to adult care ("lapsed care" [LC] group, n = 24) were followed prospectively for 12 months. All participants were provided developmentally tailored diabetes education, case management, and clinical care through a structured transition program. Results At baseline, LC participants reported lapses in care of 11.6 months. Compared with CC participants, they had higher hemoglobin A1C (A1C; p = .005), depressive symptoms ( p = .05), incidence of severe hypoglycemia ( p = .005), and emergency department visits ( p = .004). At 12-month follow-up, CC and LC participants did not differ on the number of diabetes care visits ( p = .23), severe hypoglycemia (no events), or emergency department visits ( p = .22). Both groups' A1C improved during the study period (CC: p = .03; LC: p = .02). LC participants' depressive symptoms remained elevated ( p = .10), and they reported a decline in life satisfaction ( p = .007). There was greater loss to follow-up in the LC group ( p = .04). Conclusions Our study suggests that, for young adults with a history of lapses in care, a structured transition program is effective in lowering A1C, reducing severe hypoglycemia and emergency department utilization, and improving uptake of routine diabetes care. Loss to follow-up and psychosocial concerns remain significant challenges in this population.

Background Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear. Methods This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression). Discussion AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368 ).

Continuous glucose monitoring (CGM) has been shown to be a valuable tool to improve glycemic control in patients with diabetes. The objective of this pilot study was to develop and implement CGM in an existing diabetes clinic for low-income patients on multiple daily injections.This was a single-center, prospective, randomized controlled, crossover pilot study. Initial focus groups were held to create low-literacy, Spanish and English guides to the use of carbohydrate counting and CGM. These tools were implemented to train participants on carbohydrate counting and insulin adjustments participants. Subjects were then randomized to start in Group A (CGM) or Group B (self-monitoring blood glucose and then switched after 28 weeks). Hemoglobin A1c (HbA1c) was obtained at baseline and at the end of both study phases.Twenty-five economically challenged, primarily Latino participants with minimal prior education on intensive diabetes management completed the study. No significant reduction in HbA1c or decrease in time spent in parameters of low and high blood glucose was shown. However, eighty percent of participants who completed the study wanted to continue to use CGM once the research study was over. The participants also felt that the CGM made adjusting insulin easier.CGM can be implemented in patients from a low-income public clinic; however, HbA1c reduction was not achieved. Given the underlying lack of baseline self-management knowledge, a longer trial might be necessary to see benefit with CGM in this population.

To examine the current extent of the obesity problem in 2 large pediatric clinical registries in the US and Europe and to examine the hypotheses that increased body mass index (BMI) z-scores (BMIz) are associated with greater hemoglobin A1c (HbA1c) and increased frequency of severe hypoglycemia in youth with type 1 diabetes (T1D).International (World Health Organization) and national (Centers for Disease Control and Prevention/German Health Interview and Examination Survey for Children and Adolescents) BMI references were used to calculate BMIz in participants (age 2-18 years and ≥ 1 year duration of T1D) enrolled in the T1D Exchange (n = 11,435) and the Diabetes Prospective Follow-up (n = 21,501). Associations between BMIz and HbA1c and severe hypoglycemia were assessed.Participants in both registries had median BMI values that were greater than international and their respective national reference values. BMIz was significantly greater in the T1D Exchange vs the Diabetes Prospective Follow-up (P.001). After stratification by age-group, no differences in BMI between registries existed for children 2-5 years, but differences were confirmed for 6- to 9-, 10- to 13-, and 14- to 17-year age groups (all P.001). Greater BMIz were significantly related to greater HbA1c levels and more frequent occurrence of severe hypoglycemia across the registries, although these associations may not be clinically relevant.Excessive weight is a common problem in children with T1D in Germany and Austria and, especially, in the US. Our data suggest that obesity contributes to the challenges in achieving optimal glycemic control in children and adolescents with T1D.

OBJECTIVE To evaluate the efficacy of a structured transition program compared with usual care in improving routine follow-up, clinical, and psychosocial outcomes among young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS Eighty-one young adults in their last year of pediatric care were recruited from three clinics. Intervention group (IG) participants (n = 51) received a structured transition program incorporating tailored diabetes education, case management, group education classes, and access to a newly developed young adult diabetes clinic and transition website. Control group (CG) participants (n = 30) received usual care. The primary outcome was the number of routine clinic visits. Secondary outcomes included glycemic control, hypoglycemia, health care use, and psychosocial well-being. Assessments were conducted at baseline, and 6 and 12 months. RESULTS Limitations in CG follow-up prevented direct comparisons of adult care visits; however, at the 12-month follow-up among IG participants discharged from pediatric care (n = 32), 78% had one or more adult visits. Among IG participants, the total number of clinic visits did not differ between those who transitioned and those who remained in pediatric care (3.0 ± 1.24 vs. 3.11 ± 0.94, P = 0.74). IG compared with CG participants had improved glycemic control (−0.40 ± 1.16% vs. 0.42 ± 1.51% [4.4 ± 12.7 mmol/mol vs. 4.6 ± 16.5 mmol/mol], P = 0.01), incidence of severe hypoglycemia (0.0% vs. 16%, P = 0.02), and global well-being (P = 0.02) at 12 months. CONCLUSIONS A structured transition program was successful in facilitating transition to adult care without a decrease in clinical follow-up. Compared with usual care, the transition program facilitated improvements in glycemic control, hypoglycemia, and psychosocial well-being.

OBJECTIVE We examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1–4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores. RESULTS ILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75–0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values CONCLUSIONS ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs.

Background Little is known about diet quality with a reduced-energy, low-fat, partial meal replacement plan, especially in individuals with type 2 diabetes. The Action for Health in Diabetes (Look AHEAD) trial implemented a partial meal replacement plan in the Intensive Lifestyle Intervention. Objective To compare dietary intake and percent meeting fat-related and food group dietary recommendations in Intensive Lifestyle Intervention and Diabetes Support and Education groups at 12 months. Design A randomized controlled trial comparing Intensive Lifestyle Intervention with Diabetes Support and Education at 0 and 12 months. Participants/setting From 16 US sites, the first 50% of participants (aged 45 to 76 years, overweight or obese, with type 2 diabetes) were invited to complete dietary assessments. Complete 0- and 12-month dietary assessments (collected between 2001 and 2004) were available for 2,397 participants (46.6% of total participants), with 1,186 randomized to Diabetes Support and Education group and 1,211 randomized to Intensive Lifestyle Intervention group. Main outcome measures A food frequency questionnaire assessed intake: energy; percent energy from protein, fat, carbohydrate, polyunsaturated fatty acids, and saturated fats; trans -fatty acids; cholesterol; fiber; weekly meal replacements; and daily servings from food groups from the Food Guide Pyramid. Statistical analyses performed Mixed-factor analyses of covariance, using Proc MIXED with a repeated statement, with age, sex, race/ethnicity, education, and income controlled. Unadjusted χ 2 tests compared percent meeting fat-related and food group recommendations at 12 months. Results At 12 months, Intensive Lifestyle Intervention participants had a significantly lower fat and cholesterol intake and greater fiber intake than Diabetes Support and Education participants. Intensive Lifestyle Intervention participants consumed more servings per day of fruits; vegetables; and milk, yogurt, and cheese; and fewer servings per day of fats, oils, and sweets than Diabetes Support and Education participants. A greater percentage of Intensive Lifestyle Intervention participants than Diabetes Support and Education participants met fat-related and most food group recommendations. Within Intensive Lifestyle Intervention, a greater percentage of participants consuming two or more meal replacements per day than participants consuming less than one meal replacement per day met most fat-related and food group recommendations. Conclusions The partial meal replacement plan consumed by Intensive Lifestyle Intervention participants was related to superior diet quality.

Look AHEAD (Action for Health in Diabetes) was a randomized clinical trial designed to examine the long-term health effects of weight loss in overweight and obese individuals with type 2 diabetes. The primary result was that the incidence of cardiovascular events over a median follow-up of 9.6 years was not reduced in the Intensive Lifestyle Group relative to the control group. This finding is discussed, with emphasis on its implications for design of trials and clinical treatment of obese persons with type 2 diabetes.

OBJECTIVE—In an underserved Latino area, we established a disease-management program and proved its effectiveness. However, many patients still remained above target. This study was designed to evaluate which factors are associated with reaching program goals. RESEARCH DESIGN AND METHODS—This was a randomized, prospective, observational study in which patients enrolled in our program were followed for 2 years with outcomes, measures, and questionnaires assessed at baseline and at 6, 12, and 24 months. RESULTS—Overall, A1C fell by 1%. Adherence to medication was the strongest predictor of reaching the target A1C of CONCLUSIONS—Diabetes management is effective in a lower-income Latino population. However, adherence was suboptimal even when medications were provided on-site for free. Further research into barriers associated with medication adherence is needed.

Purpose The rapid increase in obesity over the past two decades suggests that behavioral and environmental influences, including poor nutrition and physical inactivity, are fueling what is now widely recognized as a public health crisis. Yet, limited research has been conducted to examine how environmental factors, such as neighborhood-level characteristics, may be associated with increased risk for obesity. Methods Community-level risk associated with childhood obesity was examined in East Los Angeles, a community with one of the highest rates of childhood obesity in Los Angeles by triangulating: 1) spatial data for the number and location of food establishments relative to the location of schools; 2) observations regarding the availability and quality of fruits and vegetables in local grocery stores; and 3) observations regarding the quality and utilization of local parks. Results The findings revealed that there were 190 food outlets in the study community, of which 93 (49%) were fast-food restaurants. Of the fast-food restaurants, 63% were within walking distance of a school. In contrast, there were 62 grocery stores, of which only 18% sold fresh fruits and/or vegetables of good quality. Of the stores that did sell fruits and/or vegetables, only four were within walking distance of a school. Although well maintained, the five parks in this community accounted for only 37.28 acres, or 0.543 acres per 1000 residents. Conclusions These findings suggest that children have easy access to fast food, and limited access to both healthy food options and parks in which to engage in physical fitness activities. This was particularly true in areas around schools. The implications for these findings with regards to policy-related prevention and future research are discussed.