Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

Psychometric validation of the hyperglycaemia avoidance scale UK (HAS-UK).

AIMS: Hyperglycaemia aversion in type 1 diabetes can be associated with severe hypoglycaemia and impaired awareness of hypoglycaemia but is not routinely assessed clinically. This study aimed to undertake the first psychometric validation of the UK version of the Hyperglycaemia Avoidance Scale (HAS-UK). METHODS: The HAS-UK was completed by adults with type 1 diabetes in three separate research studies. Psychometric properties were evaluated, using exploratory factor analysis, internal consistency, and convergent validity. RESULTS: Of the 431 participants who completed the HAS-UK in the three studies, mean age was 49.5 years, and 58.0% were women. Mean duration of diabetes was 29 years, with 192 (44.5%) using multiple daily injections and 229 (53.1%) using an insulin pump. Five participants were excluded from analyses due to incomplete HAS-UK responses. Exploratory factor analysis revealed a 3-factor solution, with acceptable internal consistency for 'worry' and 'blood glucose decisions' factors. HAS-UK total score was higher in those using insulin pumps versus multiple daily injections, and 'blood glucose decisions' score was higher in those using a continuous blood glucose sensor versus a meter. CONCLUSIONS: The HAS-UK is a reliable measure with acceptable structural validity and is likely to be useful for evaluating hyperglycaemia aversion in people with type 1 diabetes. Future research would benefit from investigating further psychometric properties including test-retest reliability, sensitivity to change, and clinical significance of scores.

Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Translation and Validation Study of the Hypoglycemia Fear Survey in a Greek Population of Children and Adolescents with Type 1 Diabetes Mellitus and their Parents.

The present study attempted to translate and culturally adapt an established research instrument, the Hypoglycemia Fear Survey (HFS) questionnaire, to the Greek population and evaluate its validity and internal consistency so that it can be used for the assessment of hypoglycemia fear in Greek children and adolescents with T1DM and their parents. One hundred Greek children and adolescents with T1DM, 54 males, 6-18 years old, and one of their parents participated in this validation study. The participants completed the translated Greek HFS, which includes one version for children (CHFS) and one for parents (PHFS). Exploratory Factor Analysis (EFA) was used to assess construct validity. Internal consistency was assessed using Cronbach's alpha, and convergent validity was established by estimating the correlation coefficients between the scores of the HFS scales/subscales and the different constructs of the Pediatric Quality of Life Inventory. The CHFS and PHFS exhibited adequate internal consistency for the total score and the Worry subscale, but lower consistency for the Behavior subscale. High test-retest reliability was also shown. We conclude that the Greek version of the HFS is a valid and reliable instrument to assess the fear of hypoglycemia in Greek children and adolescents with T1DM and their parents.

The Development and Initial Validation of Items to Assess Parent Fear of Nighttime Hypoglycemia.

OBJECTIVE: Parents of youth with type 1 diabetes (T1D) are fearful their children will experience nighttime hypoglycemia. Currently, the Hypoglycemia Fear Survey for Parents (HFS-P) lacks items that specifically assess parents' nighttime fear. This study aimed to fill this gap by rigorously identifying new items to specifically assess parent fear of nighttime hypoglycemia and then examine the psychometric properties of the revised Hypoglycemia Fear Survey for Parents including Nighttime Fear (HFS-P-NF). METHODS: For Phase 1, we recruited 10 pediatric diabetes providers and 15 parents/caregivers of youth with T1D to generate items related to fear of nighttime hypoglycemia. For Phase 2, we recruited an additional 20 parents/caregivers to pilot-test the newly generated items. For Phase 3, we recruited another 165 parents/caregivers to evaluate structural validity via confirmatory factor analyses, reliability, and content validity of the revised HFS-P-NF. RESULTS: In Phase 1, we generated 54 items. In Phase 2, we removed 34 items due to violations of distributional normality and nonsignificant correlations. In Phase 3, a four-factor model reflecting behaviors maintaining high glucose, helplessness, negative social consequences, and nighttime worries was the best fitting model for the HFS-P-NF. The new items demonstrated strong internal consistency (α = 0.96) and strong to moderate relationships with criterion and content validity measures. CONCLUSION: The current study provides initial evidence of validity and reliability for new items on the HFS-P-NF that broadened the conceptualization of parent fear of nighttime hypoglycemia. These findings are important to clinicians who may consider screening for parent fear of nighttime hypoglycemia more comprehensively.

Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice.

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

Biobehavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-life Database Analysis.

OBJECTIVE: To document glycemic and user-initiated bolus changes following transition from predictive low glucose suspend (PLGS) system to automated insulin delivery (AID) system during real-life use. RESEARCH DESIGN AND METHODS: We conducted analysis of 2,329,166 days (6,381 patient-years) of continuous glucose monitoring (CGM) and insulin therapy data for 19,354 individuals with type 1 Diabetes, during 1-month PLGS use (Basal-IQ technology) followed by 3-month AID use (Control-IQ technology). Baseline characteristics are as follows: 55.4% female, age (median/quartiles/range) 39/19-58/1-92 years, mean ± SD glucose management indicator (GMI) 7.5 ± 0.8. Primary outcome was time in target range (TIR) (70-180 mg/dL). Secondary outcomes included CGM-based glycemic control metrics and frequency of user-initiated boluses. RESULTS: Compared with PLGS, AID increased TIR on average from 58.4 to 70.5%. GMI and percent time above and below target range improved as well: from 7.5 to 7.1, 39.9 to 28.1%, and 1.66 to 1.46%, respectively; all P values <0.0001. Stratification of outcomes by age and baseline GMI revealed clinically significant differences. Glycemic improvements were most pronounced in those <18 years old (TIR improvement 14.0 percentage points) and those with baseline GMI >8.0 (TIR improvement 13.2 percentage points). User-initiated correction boluses decreased from 2.7 to 1.8 per day, while user-initiated meal boluses remained stable at 3.6 to 3.8 per day. CONCLUSIONS: Observed in real life of >19,000 individuals with type 1 diabetes, transitions from PLGS to AID resulted in improvement of all glycemic parameters, equivalent to improvements observed in randomized clinical trials, and reduced user-initiated boluses. However, glycemic and behavioral changes with AID use may differ greatly across different demographic and clinical groups.

A parallel randomised controlled trial of the Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised self-care (HARPdoc).

Impaired awareness of hypoglycaemia (IAH) is a major risk for severe hypoglycaemia in insulin treatment of type 1 diabetes (T1D). To explore the hypothesis that unhelpful health beliefs create barriers to regaining awareness, we conducted a multi-centre, randomised, parallel, two-arm trial (ClinicalTrials.gov NCT02940873) in adults with T1D and treatment-resistant IAH and severe hypoglycaemia, with blinded analysis of 12-month recall of severe hypoglycaemia at 12 and/or 24 months the primary outcome. Secondary outcomes included cognitive and emotional measures. Adults with T1D, IAH and severe hypoglycaemia despite structured education in insulin adjustment, +/- diabetes technologies, were randomised to the "Hypoglycaemia Awareness Restoration Programme despite optimised self-care" (HARPdoc, n = 49), a psychoeducation programme uniquely focussing on changing cognitive barriers to avoiding hypoglycaemia, or the evidence-based "Blood Glucose Awareness Training" (BGAT, n = 50), both delivered over six weeks. Median [IQR] severe hypoglycaemia at baseline was 5[2-12] per patient/year, 1[0-5] at 12 months and 0[0-2] at 24 months, with no superiority for HARPdoc (HARPdoc vs BGAT incident rate ratios [95% CI] 1.25[0.51, 3.09], p = 0.62 and 1.26[0.48, 3.35], p = 0.64 respectively), nor for changes in hypoglycaemia awareness scores or fear. Compared to BGAT, HARPdoc significantly reduced endorsement of unhelpful cognitions (Estimated Mean Difference for Attitudes to Awareness scores at 24 months, -2.07 [-3.37,-0.560], p = 0.01) and reduced scores for diabetes distress (-6.70[-12.50,-0.89], p = 0.02); depression (-1.86[-3.30, -0.43], p = 0.01) and anxiety (-1.89[-3.32, -0.47], p = 0.01). Despite positive impact on cognitive barriers around hypoglycaemia avoidance and on diabetes-related and general emotional distress scores, HARPdoc was not more effective than BGAT at reducing severe hypoglycaemia.

Characteristics of adults with type 1 diabetes and treatment-resistant problematic hypoglycaemia: a baseline analysis from the HARPdoc RCT.

AIMS/HYPOTHESIS: Problematic hypoglycaemia still complicates insulin therapy for some with type 1 diabetes. This study describes baseline emotional, cognitive and behavioural characteristics in participants in the HARPdoc trial, which evaluates a novel intervention for treatment-resistant problematic hypoglycaemia. METHODS: We documented a cross-sectional baseline description of 99 adults with type 1 diabetes and problematic hypoglycaemia despite structured education in flexible insulin therapy. The following measures were included: Hypoglycaemia Fear Survey II (HFS-II); Attitudes to Awareness of Hypoglycaemia questionnaire (A2A); Hospital Anxiety and Depression Index; and Problem Areas In Diabetes. k-mean cluster analysis was applied to HFS-II and A2A factors. Data were compared with a peer group without problematic hypoglycaemia, propensity-matched for age, sex and diabetes duration (n = 81). RESULTS: The HARPdoc cohort had long-duration diabetes (mean ± SD 35.8 ± 15.4 years), mean ± SD Gold score 5.3 ± 1.2 and a median (IQR) of 5.0 (2.0-12.0) severe hypoglycaemia episodes in the previous year. Most individuals had been offered technology and 49.5% screened positive for anxiety (35.0% for depression and 31.3% for high diabetes distress). The cohort segregated into two clusters: in one (n = 68), people endorsed A2A cognitive barriers to hypoglycaemia avoidance, with low fear on HFS-II factors; in the other (n = 29), A2A factor scores were low and HFS-II high. Anxiety and depression scores were significantly lower in the comparator group. CONCLUSIONS/INTERPRETATION: The HARPdoc protocol successfully recruited people with treatment-resistant problematic hypoglycaemia. The participants had high anxiety and depression. Most of the cohort endorsed unhelpful health beliefs around hypoglycaemia, with low fear of hypoglycaemia, a combination that may contribute to persistence of problematic hypoglycaemia and may be a target for adjunctive psychological therapies.

Hypoglycemia Subtypes in Type 1 Diabetes: An Exploration of the Hypoglycemia Fear Survey-II.

OBJECTIVE: The Hypoglycemia Fear Survey-II (HFS-II) is a well-validated measure of fear of hypoglycemia in people with type 1 diabetes. The aim of this study was to explore the relationships between hypoglycemia worries, behaviors, and cognitive barriers to hypoglycemia avoidance and hypoglycemia awareness status, severe hypoglycemia, and HbA1c. RESEARCH DESIGN AND METHODS: Participants with type 1 diabetes (n = 178), with the study population enriched for people at risk for severe hypoglycemia (49%), completed questionnaires for assessing hypoglycemia fear (HFS-II), hyperglycemia avoidance (Hyperglycemia Avoidance Scale [HAS]), diabetes distress (Problem Areas In Diabetes [PAID]), and cognitive barriers to hypoglycemia avoidance (Attitudes to Awareness of Hypoglycemia [A2A]). Exploratory factor analysis was applied to the HFS-II. We sought to establish clusters based on HFS-II, A2A, Gold, HAS, and PAID using k-means clustering. RESULTS: Four HFS-II factors were identified: Sought Safety, Restricted Activity, Ran High, and Worry. While Sought Safety, Restricted Activity, and Worry increased with progressively impaired awareness and recurrent severe hypoglycemia, Ran High did not. With cluster analysis we outlined four clusters: two clusters with preserved hypoglycemia awareness were differentiated by low fear/low cognitive barriers to hypoglycemia avoidance (cluster 1) versus high fear and distress and increased Ran High behaviors (cluster 2). Two clusters with impaired hypoglycemia awareness were differentiated by low fear/high cognitive barriers (cluster 3) as well as high fear/low cognitive barriers (cluster 4). CONCLUSIONS: This is the first study to define clusters of hypoglycemia experience by worry, behaviors, and cognitive barriers to hypoglycemia avoidance. The resulting subtypes may be important in understanding and treating problematic hypoglycemia.

The Impact of a Recently Approved Automated Insulin Delivery System on Glycemic, Sleep, and Psychosocial Outcomes in Older Adults With Type 1 Diabetes: A Pilot Study.

BACKGROUND: Older adults with type 1 diabetes (≥65 years) are often under-represented in clinical trials of automated insulin delivery (AID) systems. We sought to test the efficacy of a recently FDA-approved AID system in this population. METHODS: Participants with type 1 diabetes used sensor-augmented pump (SAP) therapy for four weeks and then used an AID system (Control-IQ) for four weeks. In addition to glucose control variables, patient-reported outcomes (PRO) were assessed with questionnaires and sleep parameters were assessed by actigraphy. RESULTS: Fifteen older adults (mean age 68.7 ± 3.3, HbA1c of 7.0 ± 0.8) completed the pilot trial. Glycemic outcomes improved during AID compared to SAP. During AID use, mean glucose was 146.0 mg/dL; mean percent time in range (TIR, 70-180 mg/dL) was 79.6%; median time below 70 mg/dL was 1.1%. The AID system was in use 92.6% ± 7.0% of the time. Compared to SAP, while participants were on AID the TIR increased significantly (+10%, P = .002) accompanied by a reduction in both time above 180 mg/dL (-6.9%, P = .005) and below 70 mg/dl (-0.4%, P = .053). Diabetes-related distress decreased significantly while using AID (P = .028), but sleep parameters remained unchanged. CONCLUSIONS: Use of this AID system in older adults improved glycemic control with high scores in ease of use, trust, and usability. Participants reported an improvement in diabetes distress with AID use. There were no significant changes in sleep.

Fear of hypoglycemia in children with type 1 diabetes and their parents: Validation of the Italian version of the Hypoglycemia Fear Survey for Children and for Parents.

BACKGROUND: Currently, Italian versions of the Hypoglycemia Fear Survey for Children (CHFS) and for Parents (PHFS) quantifying Fear of Hypoglycemia (FoH) in pediatric diabetes are not available. OBJECTIVE: To validate the Italian version of the CHFS and PHFS. SUBJECTS AND METHODS: One hundred and seventy-four children with type 1 diabetes aged 6-18 and 178 parents completed the CHFS and PHFS, the PedsQL 3.0 Diabetes module and the KIDSCREEN-10. Internal consistency was good (α = 0.85 for CHFS, α = 0.88 for PHFS); validity was supported by correlations of CHFS total score (CHFS-T r = -0.50; p < 0.001, CI = -0.62 to -0.35) and Worry subscale (CHFS-W r = -0.49; p < 0.001, CI = -0.62 to -0.32) with measures of health-related quality of life (QoL), which were not related to PHFS scores. Factor analyses justified the structure and the separate scoring of Behavior and Worry subscales. Children's age was negatively correlated with CHFS-T (r = -0.16; p = 0.03, CI = -0.36 to 0.00), CHFS-W (r = -0.29; p = 0.02, CI = -0.39 to -0.07), PHFS-T (r = -0.20; p = 0.006, CI = -0.35 to -0.04), PHFS-B (r = -0.30; p = 0.001, CI = -0.43 to -0.17). Mean (SD) item scores of CHFS-T (1.47 ± 0.56 vs. 1.27 ± 0.57; p < 0.05) and CHFS-W (1.20 ± 0.73 vs. 0.96 ± 0.68; p < 0.05) were higher in children with HbA1c ≥7.5%. Higher levels of distress for upsetting hypoglycemia were associated with lower child's QoL scores as perceived by children (Peds-QL: 72.6 ± 12.8 vs. 80.4 ± 11.9; p < 0.001) and parents (Peds-QL: 70.6 ± 13.8 vs. 75.8 ± 12.9; p < 0.05). CONCLUSION: The Italian version of CHFS and PHFS appears to be a valid measure to assess FoH in clinical practice and factor analysis supports separate scoring for the Worry and Behavior subscales.

Psychometric Properties of the Hypoglycemia Fear Survey in a Clinical Sample of Adolescents with Type 1 Diabetes and Their Caregivers.

OBJECTIVE: A previously published exploratory factor analysis suggested that the Hypoglycemia Fear Survey-Child and Parent Versions, is comprised of three subscales: Maintain High Blood Glucose, Helplessness/Worry About Low Blood Glucose, and Worry About Negative Social Consequences. The primary aim of this study was to confirm this three-factor model with a clinical population of adolescents with type 1 diabetes (T1D) and their caregivers. METHODS: Participants included N = 1,035 youth ages 10-17.99 years with T1D, and their female (N = 835) and/or male (N = 326) caregivers who completed the Hypoglycemia Fear Survey independently during a routine medical appointment. We conducted confirmatory factor analysis and examined reliability of the Hypoglycemia Fear Survey and its associations with demographics and clinical outcomes (e.g., mean blood glucose, glycemic control). RESULTS: Confirmatory factor analysis supported the three-factor model in youth and female and male caregivers. The internal consistencies for Maintain High Blood Glucose, Helplessness/Worry About Low Blood Glucose, and Worry About Negative Social Consequences were acceptable. The majority of demographic and clinical outcome variables correlated as hypothesized with the three subscales. CONCLUSIONS: Using a large clinical sample of adolescents with T1D and their caretakers, we confirmed the three-factor model for the Hypoglycemia Fear Survey, which is sufficiently reliable to be used in a clinical setting. Important areas of future research include examining moderators for the effect of fear of hypoglycemia on clinical outcomes, and possible inclusion of items related to modern diabetes devices.

Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial.

Background: Closed-loop control (CLC) has been shown to improve glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. We recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; we now report patient-reported outcomes (PROs) in this iDCL trial. Methods: Participants were randomized 2:1 to CLC (N = 112) versus SAP (N = 56) and completed questionnaires, including Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline, 3, and 6 months. CLC participants also completed Diabetes Technology Expectations and Acceptance and System Usability Scale (SUS). Results: The Hypoglycemia Fear Survey Behavior subscale improved significantly after 6 months of CLC compared with SAP. DDS did not differ except for powerless subscale scores, which worsened at 3 months in SAP. Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency toward improved confidence in managing hypoglycemia. The INSPIRE questionnaire showed favorable scores in the CLC group for teens and parents, with a similar trend for adults. At baseline and 6 months, CLC participants had high positive expectations for the device with Diabetes Technology Acceptance and SUS showing high benefit and low burden scores. Conclusion: CLC improved some PROs compared with SAP. Participants reported high benefit and low burden with CLC. Clinical Trial Identifier: NCT03563313.

Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control.

Introduction: Hybrid closed-loop systems increase time-in-range (TIR) and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This article focuses on the PROs for pediatric participants (ages 6-13 years) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase TIR and improve other glycemic metrics. Research Design and Methods: One hundred and one children 6 to 13 years old with T1D were randomly assigned to closed-loop control (CLC) or sensor-augmented pump (SAP) in a 16-week randomized clinical trial with extension to 28 weeks during which the SAP group crossed over to CLC. Health-related quality of life and treatment satisfaction measures were obtained from children and their parents at baseline, 16 weeks, and 28 weeks. Results: Neither the children in the CLC group nor their parents had statistically significant changes in PRO outcomes compared with the SAP group at the end of the 16-week randomized controlled trial and the 28-week extension. Parents in the CLC group reported nonsignificant improvements in some PRO scores when compared with the SAP group at 16 weeks, which were sustained at 28 weeks. Sleep scores for parents improved from "poor sleep quality" to "adequate sleep quality" between baseline and 16 weeks, however, the change in scores was not statistically different between groups. Conclusions: Children with T1D who used the Control-IQ system did not experience increased burden compared with those using SAP based on person-reported outcomes from the children and their parents. Clinical Trials Registration: NCT03844789.

Sleep and diabetes-specific psycho-behavioral outcomes of a new automated insulin delivery system in young children with type 1 diabetes and their parents.

BACKGROUND: Data on the use of Control-IQ, the latest FDA-approved automated insulin delivery (AID) system for people with T1D 6 years of age or older is still scarce, particularly regarding nonglycemic outcomes. Children with T1D and their parents are at higher risk for sleep disturbances. This study assesses sleep, psycho-behavioral and glycemic outcomes of AID compared to sensor-augmented pump therapy (SAP) therapy in young children with T1D and their parents. METHODS: Thirteen parents and their young children (ages 7-10) on insulin pump therapy were enrolled. Children completed an initial 4-week study with SAP using their own pump and a study CGM followed by a 4-week phase of AID. Sleep outcomes for parents and children were evaluated through actigraphy watches. Several questionnaires were administered at baseline and at the end of each study phase. CGM data were used to assess glycemic outcomes. RESULTS: Actigraphy data did not show any significant change from SAP to AID, except a reduction of number of parental awakenings during the night (p = 0.036). Parents reported statistically significant improvements in Pittsburgh Sleep Quality Index total score (p = 0.009), Hypoglycemia Fear Survey total score (p = 0.011), diabetes-related distress (p = 0.032), and depression (p = 0.023). While on AID, time in range (70-180 mg/dL) significantly increased compared to SAP (p < 0.001), accompanied by a reduction in hyperglycemia (p = 0.001). CONCLUSIONS: These results suggest that use of AID has a positive impact on glycemic outcomes in young children as well as sleep and diabetes-specific quality of life outcomes in their parents.

Association between sleep disturbances, fear of hypoglycemia and psychological well-being in adults with type 1 diabetes mellitus, data from cross-sectional VARDIA study.

AIM: To assess the relationship between sleep quality, fear of hypoglycemia, glycemic variability and psychological well-being in type 1 diabetes mellitus. METHODS: Our data were provided by the VARDIA Study, a multicentric cross-sectional study conducted between June and December 2015. Sleep characteristics were assessed by the Pittsburgh Sleep Quality Index (PSQI). Fear of hypoglycemia and psychological well-being were measured with the Hypoglycemia Fear Survey version II (HFS-II) and the Hospital Anxiety and Depression Scale (HADS), respectively. Glycemic variability (GV) was determined using the CV of three 7-point self-monitoring blood glucose profiles and the mean amplitude of glycemic excursion (MAGE). RESULTS: 315 patients were eligible for PSQI questionnaire analysis: 54% women, mean age 47 ± 15, mean diabetes duration of 24 ± 13 years, HbA1c of 7.6 ± 0.9% (60 ± 7,5mmol/mol). Average PSQI score was 6.0 ± 3.3 and 59.8% of the patients had a PSQI score > 5. HFS-II score and HADS were significantly higher among "poor" sleepers (p < 0.0001) and PSQI score was positively associated with HADS (ß = 0.22; 95% CI = 0.08;0.35). GV evaluated by CV or MAGE did not differ between "poor" and "good" sleepers (p = 0.28 and 0.54, respectively). CONCLUSIONS: Adult patients with type 1 diabetes have sleep disturbances which correlate with psychological well-being. This study suggests that psychological management can be a target to improve sleep quality in adults with type 1 diabetes mellitus.