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Objective: A subgroup analysis of the Hypoglycemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycemia persisting despite optimized care (HARPdoc) trial was conducted to explore the impact of Blood Glucose Awareness Training (BGAT, a hypoglycemia awareness training program) and the HARPdoc (a psychoeducation addressing unhelpful hypoglycemia beliefs) in reducing severe hypoglycemia (SH) in individuals using advanced diabetes technologies (ADTs). Methods: Data from trial participants who utilized ADTs, including continuous glucose monitors or automated insulin delivery systems, were extracted. Generalized linear mixed-effects models with Poisson distribution or linear mixed-effects models were used to evaluate SH incidence, and Gold questionnaire, Attitudes to Awareness of Hypoglycemia (A2A), Problem Areas in Diabetes (PAID), Hospital Anxiety and Depress Scale (HADS)-anxiety, and HADS-depression scores as measures of hypoglycemia awareness, unhelpful hypoglycemia beliefs, diabetes distress, and anxiety and depression symptoms, respectively. Results: In the 45 participants using ADTs, the BGAT and HARPdoc interventions both reduced SH incidence by more than 50% ( P < 0.0001) and yielded improvements in hypoglycemia awareness ( P < 0.05). HARPdoc outperformed BGAT in reducing SH at month 24 ( P = 0.01). HARPdoc also mitigated unhelpful hypoglycemia beliefs ( P < 0.0001), diabetes distress ( P < 0.05), and anxiety symptoms ( P < 0.05); BGAT demonstrated no significant impacts in these respects. Neither HARPdoc nor BGAT had significant effects on depression symptoms. Conclusion: Psychoeducation (BGAT and HARPdoc) was effective in reducing SH in people using ADTs. HARPdoc may also provide greater long-term SH reduction and improves psychological well-being in this patient group.

Objective: To assess the clinical impact of flash glucose monitoring (FGM) systems on fear of hypoglycemia (FoH) and quality of life in adults with type 1 diabetes mellitus (T1DM). Methods: Prospective quasi-experimental study with a 12-month follow-up. People with T1DM (18-80 years old) and self-monitoring by blood capillary glycemia controls were included. The FH15 questionnaire, a survey validated in Spanish in a comparable study population, was used to diagnose FoH with a cutoff point of 28 points. Results: A total of 181 participants were included, with a FoH prevalence of 69% ( n  = 123). A mean reduction in FH15 score of -4 points (95% confidence interval [-5.5 to -3]; P  < 0.001) was observed, along with an improvement in quality of life (EsDQOL-test (Diabetes Quality of Life, Spanish version), -7 points [-10; -4], P  < 0.001) and satisfaction with treatment (Diabetes Treatment Satisfaction questionnaire, self-reported version [DTSQ-s] test, +4.5 points [4; 5.5], P  < 0.001). At the end of the follow-up, 64.2% of the participants saw an improved FoH intensity, compared to 35.8% who scored the same or higher. This improvement in FoH status was associated with a higher time-in-range at the end of the follow-up ( P  = 0.003), as well as a lower time spent in hyperglycemia ( P  = 0.005). In addition, it was linked to participants with a high baseline FoH levels ( P  < 0.001) and those who were university degree holders ( P  = 0.07). Conclusions: FGM is associated with an overall reduction of FoH in adults with T1DM and with an increase in their quality of life. Nevertheless, a significant percentage of patients may experience an increase of this phenomenon leading to clinical repercussions and a profound impact on quality of life.

Background: Hypoglycemic confidence (HC) represents the degree to which an individual feels secure regarding his or her ability to stay safe from hypoglycemia-related problems. Self-report scales assessing HC in adults with type 1 diabetes (T1D) have found that greater HC is associated with better glycemic control and that HC rises significantly after real-time continuous glucose monitoring is introduced. To determine whether HC might be similarly meaningful in the partners of T1D adults, we developed the Hypoglycemic Confidence Scale for Partners (Partner-HCS). This article describes the construction and validation of the Partner-HCS and examines how HC in T1D partners is related to hypoglycemia-related experience and key psychosocial constructs. Methods: Items were developed from interviews with seven T1D partners, resulting in 12 self-report items. Exploratory factor analysis (EFA) was then conducted on data collected from T1D partners ( n  = 218). Variables to establish construct validity for the Partner-HCS included partner-reported diabetes distress, hypoglycemic fear, generalized anxiety, and confidence regarding glucagon use, as well as frequency of recent severe hypoglycemia in the T1D adult. Hierarchical regression analyses examined the unique contribution of Partner-HCS scores, independent of hypoglycemic fear, to key psychosocial constructs and hypoglycemia-related factors. Results: EFA of the 12 items yielded a single-factor solution, accounting for 51.2% of the variance. Construct validity was demonstrated by significant univariate associations with key psychosocial constructs. Importantly, Partner-HCS total score was, independent of hypoglycemic fear, significantly associated with diabetes distress ( P  < 0.05), overall relationship satisfaction ( P  = 0.004), number of severe hypoglycemic episodes in the last 6 months ( P  < 0.05), and confidence using glucagon ( P  = 0.007). In total, 38.5% of T1D partners indicated relatively low HC. Conclusions: HC is an important facet of the experiences of T1D partners. It is related to, yet distinct from, hypoglycemic fear. The Partner-HCS is a reliable, valid method for assessing HC in partners of T1D adults.

Background: In April 2017, the Australian Government announced the full subsidy of continuous glucose monitors (CGM) to children and young people <21 years with type 1 diabetes (T1D). This study aimed to evaluate the effect of CGM on psychosocial outcomes in a T1D pediatric population-based sample. Methods: Children with T1D, commencing CGM between June 2017 and January 2018, and their parents were recruited in a prospective cohort study in a tertiary pediatric hospital in Western Australia. Parents and children older than 12 years self-completed questionnaires at onset of CGM and 2 months later, on fear of hypoglycemia (FOH) and diabetes treatment satisfaction (DTS). Parents provided measures of sleep quality. Children completed the Gold hypoglycemia awareness score. Hemoglobin A1c (HbA1c) values were compared at baseline (BL) and follow-up (FU). Results: Sixty parents and 38 children provided measures at BL and FU. Parental total FOH decreased (mean score BL vs. FU; 50.0 vs. 44.3, P  = 0.004) with reduction in the Worry subscore (28.2 vs. 24.2, P  = 0.004). Furthermore, parental and child DTS increased. Parental sleep quality improved ( P  < 0.001) and overnight finger prick testing decreased ( P  < 0.001). Impaired hypoglycemic awareness decreased in children (26.3% vs. 10.5%, P  = 0.031). HbA1c reduced from 8.4% (68 mmol/mol) to 8.1% (65 mmol/mol) ( P  = 0.036). Conclusions: Introduction of subsidized CGM showed early improvement in psychosocial and glycemic outcomes in patients and their families in Western Australia. Ongoing evaluation is essential to assess whether equitable access to CGM will translate to sustained benefits for Australian T1D pediatric patients.

Background: Continuous glucose monitoring (CGM) has potential to address challenges of type 1 diabetes (T1D) management for young children. CGM use is increasing, yet remains underutilized. Characterizing parents' experiences with CGM can inform clinical strategies to help parents make decisions about diabetes management, overcome obstacles to initiating and sustaining CGM use, and maximize benefits of CGM use in their children's diabetes care. Methods: Transcripts from semistructured qualitative interviews with 55 parents of children aged 1 to <8 years, with T1D duration ≥6 months, and whose child currently or previously used CGM were coded and analyzed to derive themes about their experiences with CGM. Results: Participants were 88% mothers and the mean child age was 5.0 ± 1.5 years. Parents described benefits of CGM use: decreased worry about glucose excursions, improved sleep, increased sense of safety with children who cannot recognize or express symptoms of hypo- or hyperglycemia, and greater comfort with other caregivers, especially using remote monitoring functionality when away from children. Challenges included painful insertions, wearing multiple devices on small bodies, disruptive alerts, data gaps due to lost signals, skin/adhesive problems, and difficulty interpreting the amount of information generated by CGM. For some, the challenges outweighed potential benefits and they stopped CGM use. Conclusions: CGM may address unique challenges of T1D in young children and increase parental comfort with diabetes management, yet there are multiple barriers to initiating or maintaining CGM use. Education and behavioral support to address these benefits and barriers may equip caregivers with skills to address challenges of CGM use.

Objective: Factors associated with maternal functioning in biological mothers whose infants were admitted to a Neonatal Intensive Care Unit (NICU) were identified as measured by a modified version of the Barkin Index of Maternal Functioning. Materials and Methods: This multivariable regression analysis explored sociodemographic and clinical data from 146 mother-infant dyads admitted to a Level III NICU between February 2015 and May 2016. Eligible dyads included: (1) adult biological mothers with singleton infants discharged home alive after NICU admission meeting criteria and (2) infants discharged home alive from the NICU with adult, biological mothers after a minimum 6-day admission. Results: Lower scores on the Edinburgh Postnatal Depression Scale ( p  < 0.0001), and an infant admission diagnosis of hypoglycemia ( p  = 0.0295) were significantly associated with higher levels of maternal functioning. Conclusions: The significant association between maternal functioning and depressive symptom score is corroborated by the literature. Results relative to a diagnosis of infant hypoglycemia and higher levels of maternal functioning are intriguing, considering current literature linking increased postpartum depression to gestational diabetes. The severity of other possible admission diagnoses may provide a partial explanation. We believe this is the first study suggesting a potential role between infant admission diagnosis and the level of maternal functioning.

Background: There is limited published evidence regarding the psychological effect of use of continuous glucose monitoring (CGM) in the pediatric population with type 1 diabetes mellitus on metabolic control, fear of hypoglycemia, and patient or carer well-being. The aim of this study was to evaluate the effects of CGM on patient and carer well-being, worry, fear of hypoglycemia, and glycemic control., Methods: Children aged >12 years independently completed the hypoglycemia fear survey (HFS). Parents and carers of children using CGM for a minimum of 12 months were asked to complete a modified version of the hypoglycemia fear survey for parents of young children (HFS-P) before and after CGM usage., Results: Sixteen patients (8 boys) were included with median age of 13.5 years (2-17 years) and use of CGM for a minimum of 12 months. There was no significant improvement in the glycated hemoglobin after 12 months of CGM usage. Parents of all 16 patients completed the HFS-P survey. Of 12 young people eligible (age >12 years), 11 returned the HFS survey. Significant improvement was seen in both parental and patient fear of hypoglycemia after CGM (P < 0.001 and P = 0.003, respectively)., Conclusion: The use of CGM did not show any significant improvement in glycemic control after 12 months; however, parental and children's fear of hypoglycemia and worry were significantly reduced after the use of CGM. Larger studies on the psychological effects of CGM are warranted.

Background: Hybrid closed loop (HCL) systems are designed to automate insulin delivery to improve type 1 diabetes (T1D) outcomes and reduce user burden and distress. Because the systems only automate some aspects of diabetes care, psychosocial and human factors remain an important consideration in their use. Thus, we examined whether psychosocial and human factors (i.e., distress related to diabetes management, fear of hypoglycemia, and technology attitudes) would (1) change after using the system and (2) predict glycemic outcomes during the trial., Subjects and Methods: Fourteen adults and 15 adolescents with T1D participated in a multisite clinical trial of an investigational version of the MiniMed™ 670G system (Medtronic, Northridge, CA) over 4 to 5 days in a semisupervised outpatient setting. Users completed surveys assessing psychosocial and human factors before beginning the HCL system and at the conclusion of the study. t-Tests and regression analyses were conducted to examine whether these factors changed following trial exposure to the HCL system and predicted glycemic outcomes during the trial., Results: Diabetes management distress decreased and diabetes technology attitudes became more positive over the trial period. Fear of hypoglycemia did not change over the trial period. There was a trend toward greater pretrial management distress predicting less time in range during the trial, controlling for time in range before the trial., Conclusions: Results suggest that this system is promising for enhancing technology attitudes and reducing management distress. Psychosocial factors, such as management distress, may negatively impact glycemic outcomes and should be a priority area for further investigation.

Background: We update the psychometric properties of the Hypoglycemia Fear Survey-Parents of Young Children (HFS-PYC), a 26-item measure of parents' hypoglycemia fear for young children using an insulin pump., Methods: We combined three similar datasets for the analyses. The data analyzed included parents' responses to the HFS-PYC and a demographic form. For a subset of children (n = 91), we also analyzed self-monitoring of blood glucose data. We used confirmatory factor analysis (CFA) to confirm the measure's original factor structure. Additional analyses examined reliability and validity of a revised HFS-PYC for parents of young children using pumps., Results: We analyzed data from 116 parents (93% mothers). Mean child age and HbA1c were 5.2 ± 1.3 years and 8.2% ± 1.1%, respectively. CFA identified a 22-item two-factor solution (χ 2 (208, n = 116) = 368.688, P < 0.001, root mean square error of approximation = 0.08, comparative fit index = 0.94, and Tucker-Lewis index = 0.93) with factors corresponding to the original subscales: worry and behavior. The revised subscales demonstrated at least adequate internal consistency (Cronbach's alpha >0.65). Correlations revealed significant negative associations between current HFS-PYC worry scores and children's mean daily blood glucose and percent of very high glucose levels per day, suggesting less fear among parents of young children with elevated glycemic levels. In addition, there was a positive association with the percent of glucose levels in target, suggesting greater hypoglycemia fear among parents of children who have better control., Conclusions: Results provide preliminary evidence for the reliability and validity of a reduced 22-item HFS-PYC for parents of children using insulin pumps., Competing Interests: Author Disclosure Statement No competing financial interests exist.

Background: While research designed to understand the concerns about hypoglycemia among patients with diabetes has been primarily focused on the investigation of fear and anxiety, recent evidence suggests a potentially important and conceptually distinct element-hypoglycemic confidence. To investigate this dimension, we developed the Hypoglycemic Confidence Scale (HCS); herein, we describe the construction and validation of the HCS and examine how key patient factors are associated with hypoglycemic confidence., Methods: Items were developed from interviews with six type 1 diabetes (T1D) adults, six insulin-using type 2 diabetes (T2D) adults, and seven diabetes healthcare professionals, resulting in nine self-report items. Separate exploratory factor analyses (EFAs) were conducted with T1D adults (N = 326), with T2D adults using both basal and prandial insulins (T2D-BP, N = 145) and with T2D adults using only basal insulin (T2D-BO, N = 82). Construct validity for the HCS was established with overall well-being (World Health Organization-5), diabetes distress (Diabetes Distress Scale), global anxiety (Generalized Anxiety Disorder), hypoglycemic fear (Hypoglycemic Fear Survey-II), and glycemic control (self-reported A1C). Hierarchical regression analyses examined the unique contribution of HCS scores, independent of hypoglycemic fear, on key psychosocial constructs and A1C., Results: EFAs of the nine HCS items yielded a single factor solution for each of the three subject samples, accounting for 50.8%, 65.1%, and 73.7% of the variance for the T1D, T2D-BP, and T2D-BO groups, respectively. Construct validity was established by significant correlations with criterion variables. The HCS was associated with well-being and diabetes distress in the T1D (in both cases, P < 0.001) and T2D-BP groups (in both cases, P < .05) and for self-reported A1C in the T2D-BP group (P < .05) independent of hypoglycemic fear., Conclusions: Hypoglycemic confidence is a unique dimension of patient experience, different from hypoglycemic fear, and is deserving of further study. The HCS is a reliable valid measure of hypoglycemic confidence for adults with T1D and insulin-using T2D.

Background: Color affects emotions, feelings, and behaviors. We hypothesized that color used in self-monitoring of blood glucose (SMBG) is helpful for patients to recognize and act on their glucose levels to improve glycemic control. Here, two color-indication methods, color record (CR) and color display (CD), were independently compared for their effects on glycemic control in less frequently insulin-treated type 2 diabetes., Subjects and Methods: One hundred twenty outpatients were randomly allocated to four groups with 2×2 factorial design: CR or non-CR and CD or non-CD. Blood glucose levels were recorded in red or blue pencil in the CR arm, and a red or blue indicator light on the SMBG meter was lit in the CD arm, under hyperglycemia or hypoglycemia, respectively. The primary end point was difference in glycated hemoglobin (HbA1c) reduction in 24 weeks. Secondary end points were self-management performance change and psychological state change., Results: HbA1c levels at 24 weeks were significantly decreased in the CR arm by -0.28% but were increased by 0.03% in the non-CR arm (P=0.044). In addition, diet and exercise scores were significantly improved in the CR arm compared with the non-CR arm. The exercise score showed significant improvement in the CD arm compared with the non-CD arm but without a significant difference in HbA1c reduction. Changes in psychological states were not altered between the arms., Conclusions: CR has a favorable effect on self-management performance without any influence on psychological stress, resulting in improved glycemic control in type 2 diabetes patients using less frequent insulin injection. Thus, active but not passive usage of color-indication methods by patients is important in successful SMBG.

Background: Continuous glucose monitoring (CGM) has been shown to improve glycemic control and reduce hypoglycemia with consistent use. Youth, however, are unlikely to use CGM consistently. We compared psychological characteristics of youth with type 1 diabetes, their parents, and adults with type 1 diabetes randomized to CGM or standard blood glucose monitoring (BGM). This study was an ancillary study, and participants completed the questionnaires at the 6-month visit of the main study., Subjects and Methods: Participants enrolled at a single site of the Juvenile Diabetes Research Foundation CGM trial completed questionnaires and provided diabetes management data. Participants were randomized to the CGM or BGM group for 6 months., Results: Parents in both groups reported more fear of hypoglycemia than youth in the corresponding groups. CGM youth and parents reported more negative affect around BGM than those in the BGM group. CGM youth reported more trait anxiety than BGM youth, whereas CGM adults reported less state and trait anxiety than BGM adults. CGM parent-proxy report of depression was significantly higher than that reported by BGM parents., Conclusions: Youth, their parents, and adults report different psychological impacts of CGM use. In some groups and with some variables, CGM use was associated with a positive psychosocial impact, whereas in others CGM use was associated with a negative psychosocial impact. Future research should explore the psychological consequences of CGM use.

Background: The aims of this study were (1) to demonstrate the reliability and validity of the Impact of Weight on Activities of Daily Living Questionnaire (IWADL), a measure of ability to perform daily physical activities, in individuals with type 2 diabetes who are moderately obese and (2) to characterize those individuals with low self-reported ability., Methods: Data from a web-based survey of individuals with type 2 diabetes and body mass index (BMI) of 30-40 k/mg(2) were used to calculate Cronbach's α and demonstrate both IWADL factorial and construct validity. These data were entered into a multivariable multinomial logistic regression model with survey variables (demographics, health status, weight- and diabetes-related) as the independent variables and three IWADL scoring groups (Low, Medium, and High) as the dependent variables., Results: Study participants were 349 individuals with type 2 diabetes (mean age = 59 years, 44% male, 91% white, mean BMI = 35 k/mg(2)). Factor analysis indicated a one-factor solution for a seven-item IWADL with Cronbach's α = 0.94. Significant (P < 0.05) relationships were identified between IWADL and variables previously shown to be related to level of physical activity. Ten variables remained independently (P < 0.05) related to IWADL scores, including age, gender, health status, current exercise, using exercise programs or hypnosis as a step to lose weight, and self-reported weight history., Conclusions: The IWADL is a reliable and valid measure of the ability of individuals with type 2 diabetes and moderate obesity to perform daily physical activities. This ability may be an important patient-reported end point to include in clinical trials of antihyperglycemic medications that produce weight loss.

Background: We surveyed the extent of fear of hypoglycemia in people with type 1 diabetes treated by continuous subcutaneous insulin infusion (CSII) and tested the hypothesis that suboptimal glycemic control during CSII is related to fear of hypoglycemia., Methods: We audited nonpregnant type 1 diabetes patients attending an Insulin Pump Clinic with at least 6 months' duration of CSII. In 104 eligible subjects, fear of hypoglycemia was assessed by questionnaire; 75 responded., Results: The median duration of CSII was 5 years (range, 1-29 years). Poor glycemic control (hemoglobin A1c [HbA1c] ≥ 8.5%; mean ± SD, 9.1 ± 1.0%) was present in 27%, and this group had more men than a good-control group with HbA1c < 7.0% (43% vs. 11%). Substantial fear of hypoglycemia (score > 50%) occurred in 27% of subjects, but fear of hypoglycemia was not correlated with HbA1c. The only significant correlates of fear of hypoglycemia were accumulated episodes of severe hypoglycemia (r = 0.48, P < 0.001) and rate of hypoglycemia on CSII (r = 0.48, P < 0.001). The HbA1c on CSII was correlated with multiple daily injection (MDI) HbA1c (r = 0.66, P < 0.001) and the change in HbA1c (r = 0.63, P < 0.001)., Conclusions: Fear of hypoglycemia is not correlated with, and is unlikely to be a major determinant of, HbA1c on CSII. Other factors (such as HbA1c on MDI and adherence to insulin pump procedures) are likely to be more important. Nevertheless, substantial fear of hypoglycemia is present in many CSII-treated people and may adversely affect quality of life and psychological well-being.

Background: Preventing the complications of diabetes requires tight control and minimizing blood glucose fluctuation. Pursuing these goals increases the risk of severe hypoglycemia. The authors hoped to identify if using continuous glucose monitoring (CGM) decreased the incidence of severe hypoglycemia, resulted in less fear of hypoglycemia, and improved patient empowerment and what impact CCM had on quality of life (QOL) issues., Methods: Questionnaires were used to gather demographic data, to measure educational experiences with CGM, QOL issues concerning fear of hypoglycemia and severe hypoglycemia, confidence to make changes to insulin regimens before and after using CGM, and the incidence of severe hypoglycemia before and while using CGM, and to assess the impact of CGM on QOL., Results: The data and answers reported suggest significantly less fear of hypoglycemia and severe hypoglycemia and increased patient empowerment with CGM. Further shown is a reduced incidence of acute complications as evidenced by significantly decreased incidence of severe hypoglycemia. CGM appears to have a significant, positive impact on the stress associated with having and managing diabetes., Conclusions: Using CGM as part of the diabetes self-management plan offers the potential to significantly improve user outcomes as measured by QOL, reduction of fear, and patient empowerment. Using CGM can allow patients to achieve tighter control of their blood glucose values with reduced fear of hypoglycemia, reduced incidence of severe hypoglycemia, and a decreased sense of burden from having diabetes.

Background: In diabetes, strict glycemic control reduces risk of complications. One mode of therapy is continuous intraperitoneal insulin infusion (CIPII). With CIPII, like all intensified treatment strategies, frequent assessment of glucose levels is mandatory. Real-time (RT)-continuous glucose monitoring (CGM) gives RT information without the need for multiple invasive measurements. In theory, CIPII combined with RT-CGM could provide near normal glucose profiles. The objective of this study is to investigate effectiveness and safety of RT-CGM in patients treated with intraperitoneal insulin through an implanted pump., Methods: In an open-label, crossover, randomized study, effects of 6-day open RT-CGM use were studied in 12 type 1 diabetes patients on CIPII, with blinded RT-CGM used as a control. Primary outcome was time in euglycemia. Secondary outcomes included time in other glucose ranges, incidence of adverse events, and patient satisfaction. Agreement of self-measurement of blood glucose (SMBG) and RT-CGM measurements was assessed., Results: Median time spent in euglycemia was 68.2% (55.9-72.3%) with open RT-CGM and 64.9% (55.3-71.2%) with blinded RT-CGM (P = 0.25). Time spent in other glucose ranges did not differ (P > 0.05). There were no serious adverse events. Patient satisfaction was good. Median relative absolute difference of SMBG and RT-CGM values was 13.9%. Bland-Altman analysis showed a mean difference of -0.31 mg/dL with lower and upper limits of agreement of -77.0 and +76.4 mg/dL, respectively., Conclusions: Short-term use of RT-CGM, although safe and with good patient satisfaction, does not result in more time spent in euglycemia, nor does it change time spent in other glucose ranges in our population of type 1 diabetes patients receiving CIPII.