Diabetes-related Quality Of Life Research Articles

Sex-driven factors associated with anxiety and depression in autoimmune diabetes.

To analyze the prevalence of anxiety and depression in a large cohort of adults with autoimmune diabetes, identifying sex-driven associated factors. In this cross-sectional study, we enrolled 553 consecutive adults with Type 1 diabetes mellitus or latent autoimmune diabetes in adults who came to the Division of Endocrinology of the S.Orsola-Malpighi Polyclinic, Bologna (Italy),to receive their second dose of SARS-CoV-2 vaccine. We administered the questionnaires: Hospital Anxiety and Depression Scale, Diabetes Distress Scale, Diabetes-related Quality of Life, Diabetes Treatment Satisfaction Questionnaire. We collected clinical and biochemical data and 14 days glucose metrics in patients with sensor use > 70% in a time span of ± 4months from the questionnaires' administration. We excluded 119 patients from our analyses with missing data (final cohort n = 434: 79% of those enrolled). Anxiety and depression prevalence was respectively 30.4% and 10.8%. According to the multivariate analysis, higher diabete-related emotional burden, lower treatment satisfaction, but not physician-related distress, were risk factors for anxiety and depression; female sex was associated with anxiety (OR 0.51, 95% 0.31-0.81; p = 0.005); in women, depression was associated with increasing age (males vs. females OR 0.96 per 1year increase, 95% CI 0.92-1.00; p = 0.036), whilst in men with HbA1c (OR 1.08 per 1mmol/mol increase, 95% CI 1.03-1.13; p = 0.002). Nearly 1/3 of patients with autoimmune diabetes suffers from anxiety and 1/10 from depression. These conditions are associated with independent modifiable and non-modifiable characteristics. For depression, these characteristics differ between males and females.

Comparison of the Sensor-Augmented Pump System with the Advanced Hybrid Closed-Loop Delivery System: Quality of Life, Diabetes Distress, and Glycaemic Outcomes in a Real-Life Context.

Type 1 diabetes mellitus (T1D) is a chronic disease that requires exogenous insulin administration and intensive management to prevent any complications. Recent innovations in T1D management technologies include the Advanced Hybrid Closed-Loop delivery system (AHCL). The pioneer AHCL system provides automated basal and automated bolus corrections when needed. This study aimed to compare the Advanced Hybrid Closed-Loop (AHCL) system and the Sensor-Augmented Pump (SAP) with Predictive Low Glucose Management (PLGM) system, in relation to glycaemic outcomes, general and diabetes-related Quality of Life (QoL), and diabetes distress. General and diabetes-related QoL were assessed with the Diabetes Quality of Life Brief Clinical Inventory (DQOL-BCI) and the World Health Organization Quality of Life-BREF (WHOQOL-BREF), respectively. Diabetes distress was assessed with the Diabetes Distress Scale for Type 1 diabetes (T1-DDS). Eighty-nine T1D adults participated in the study, mostly females (65.2%), with a mean age of 39.8 (± 11.5 years). They had on average 23 years of diabetes (± 10.7) and they were on continuous subcutaneous insulin infusion therapy. Significant differences favoring the AHCL over the SAP + PLGM system were demonstrated by lower mean glucose levels, less time above range, lower scores on DQOL-BCI, T1-DDS, and higher scores on WHOQOL-BREF. Finally, the linear regression models revealed the association of time in range in most of the above aspects. This study highlighted the advantages of the AHCL system over the SAP + PLGM system in the real-world setting in relation to general and diabetes-related QoL, diabetes distress, and glycaemic outcomes.

Quality of life, stress, anxiety and depression and associated factors among people with type 2 diabetes mellitus in Western region Saudi Arabia.

The objective of this study is to evaluate the quality of life (QoL), depression, anxiety, and stress, along with associated factors among individuals with diabetes in Saudi Arabia. This survey was conducted at King Abdulaziz University (KAU), Jeddah, Kingdom of Saudi Arabia (KSA). The assessment of depression, anxiety, and stress related to Type 2 Diabetes Mellitus (T2DM) was conducted using the DASS-21 questionnaire, while diabetes-related QoL was evaluated using the revised version of the diabetes QoL questionnaire (RV-DQoL13). Data were analyzed using SPSS-26. A total of 251 subjects were included in the study (165 [65.7%] males and 86 [34.3%] females, mean age 50.1 ± 14.5 years). The individuals with DM had a mean value of QoL of 29.16 ± 9.23, with 46.9% having poor QoL. Furthermore, in dimensions of QoL, almost half of the individuals reported high worry about the disease (49.6%), followed by a high diabetes impact (46.6%) and low life satisfaction (42.9%). The prevalence of depression, anxiety, and stress was 49.4, 71.7, and 49.8%, respectively. A significant correlation was found between depression, anxiety, and stress and DASS-21 scores with QoL (p < 0.001). The regression analysis indicated an association of distinct factors with QoL like age above 41 years (p = 0.004), being married (p < 0.001), being divorced (p = 0.04), higher education (p = 0.007), regular medicine intake (p = 0.01), regular exercise (p = 0.03), lipid profile (p = 0.01), HbA1c (p < 0.001), and DASS-21 scores (p < 0.001). Poor QoL score (TQoL score > 27) was significantly associated with depression, anxiety, and stress (p < 0.001). The participants with higher monthly income, shorter disease duration, regular medicine use, and altered lipid profile, and older subjects had a lower chance of depression, anxiety, and stress. Approximately half of individuals with T2DM experienced poor QoL, while the prevalence rates for depression, anxiety, and stress were 49.4, 71.7, and 49.8%, respectively. Scores in the domains of impact, worry, and satisfaction were below optimal levels. Several factors were linked to QoL and depression, anxiety, and stress, and an association was observed between DASS-21 scores and QoL.

Costs and Health Care Utilization Analysis of Medical Group Visits for Adults With Type 2 Diabetes in Community Health Centers.

We evaluated the economic impact of group visits (GVs) in adults with uncontrolled diabetes in community health centers (CHCs) in the United States. In this prospective controlled trial, we implemented 6 monthly GV sessions in 5 CHCs and compared intervention patients (n=49) to control patients (n=72) receiving usual care within the same CHCs. We conducted patient chart reviews to obtain health care utilization data for the prior 6 months at baseline, 6 months (during the GV implementation), and 12 months (after the implementation). We also collected monthly logs of CHC expenses and staff time spent on activities related to GVs. Per-patient total costs included CHCs' expenses and costs associated with staff time and patients' health care use. For group comparison, we used the Wilcoxon rank-sum test and the bootstrapping method that was to bootstrap generalized estimating equation models. The GV group had fewer 6-month hospitalizations (mean: GV: 0.06 vs. control: 0.24, rate: 6.1% vs. 19.4%) ( P ≤ 0.04) and similar emergency department visits at 12 months than the control group. Implementing GV incurred $1770 per-patient. The intervention cost $1597 more than the control at 6 months ($3021 vs. $1424) but saved $1855 at 12 months ($857 vs. $2712) ( P =0.002). The diabetes GV care model reduced hospitalizations and had cost savings at 12 months, while it improved patients' diabetes-related quality of life and glucose control. Future studies should assess its lifetime cost-effectiveness through a randomized controlled trial.

Outcomes measured in studies assessing health systems interventions for type 1 diabetes management: A scoping review.

Describe the outcomes reported in research on health systems interventions for type 1 diabetes management in comparison to the outcomes proposed by a core outcome set (COS) for this condition, an essential list of outcomes that studies should measure. Systematic search of studies published between 2010 and 2021 reporting health systems interventions directed to improve the management of type 1 diabetes using PubMed, EMBASE and CENTRAL. Information on the outcomes was extracted and classified according to a COS: self-management, level of clinical engagement, perceived control over diabetes, diabetes-related quality of life, diabetes burden, diabetes ketoacidosis, severe hypoglycemia, and glycated hemoglobin (HbA1C). 187 studies were included. Most of the studies included either children (n = 82/187) or adults (n = 82/187) living with type 1 diabetes. The most common outcome measured was HbA1C (n = 149/187), followed by self-management (n = 105/187). While the least measured ones were diabetes ketoacidosis (n = 15/187), and clinical engagement (n = 0/187). None of the studies measured all the outcomes recommended in the COS. Additionally, different tools were found to be used in measuring the same outcome. This study provides a description of what researchers are measuring when assessing health systems interventions to improve type 1 diabetes management. In contrast to a COS, it was found that there is a predominance of clinical-based outcomes over patient-reported outcome measures.

The Effect of Do-It-Yourself Real-Time Continuous Glucose Monitoring on Glycemic Variables and Participant-Reported Outcomes in Adults With Type 1 Diabetes: A Randomized Crossover Trial.

Real-time continuous glucose monitoring (rtCGM) has several advantages over intermittently scanned continuous glucose monitoring (isCGM) but generally comes at a higher cost. Do-it-yourself rtCGM (DIY-rtCGM) potentially has benefits similar to those of rtCGM. This study compared outcomes in adults with type 1 diabetes using DIY-rtCGM versus isCGM. In this crossover trial, adults with type 1 diabetes were randomized to use isCGM or DIY-rtCGM for eight weeks before crossover to use the other device for eight weeks, after a four-week washout period where participants reverted back to isCGM. The primary endpoint was time in range (TIR; 3.9-10 mmol/L). Secondary endpoints included other glycemic control measures, psychosocial outcomes, and sleep quality. Sixty participants were recruited, and 52 (87%) completed follow-up. Glucose outcomes were similar in the DIY-rtCGM and isCGM groups, including TIR (53.1% vs 51.3%; mean difference -1.7% P = .593), glycosylated hemoglobin (57.0 ± 17.8 vs 61.4 ± 12.2 mmol/L; P = .593), and time in hypoglycemia <3.9 mmol/L (3.9 ± 3.8% vs 3.8 ± 4.0%; P = .947). Hypoglycemia Fear Survey total score (1.17 ± 0.52 vs 0.97 ± 0.54; P = .02) and fear of hypoglycemia score (1.18 ± 0.64 vs 0.97 ± 0.45; P = .02) were significantly higher during DIY-rtCGM versus isCGM. Diabetes Treatment Satisfaction Questionnaire status (DTSQS) score was also higher with DIY-rtCGM versus isCGM (28.7 ± 5.8 vs 26.0 ± 5.8; P = .04), whereas diabetes-related quality of life was slightly lower (DAWN2 Impact of Diabetes score: 3.11 ± 0.4 vs 3.32 ± 0.51; P = .045); sleep quality did not differ between the two groups. Although the use of DIY-rtCGM did not improve glycemic outcomes compared with isCGM, it positively impacted several patient-reported psychosocial variables. DIY-rtCGM potentially provides an alternative, cost-effective rtCGM option.

Diabetes-Related Quality of Life Assessment in Children following Total Pancreatectomy with Islet Autotransplantation

Total pancreatectomy with islet autotransplantation (TPIAT) can improve pain and reduce functional impairment associated with acute recurrent or chronic pancreatitis. However, long-term glucose monitoring and insulin therapy are often required, which can adversely affect the quality of life. We sought to evaluate diabetes-related quality of life (DR-QOL) in youth who underwent TPIAT and compare it to the youth with new-onset type 1 diabetes (T1D). The Pediatric Quality of Life Inventory™ 3.2 Diabetes Module (PedsQL™ DM) was used to assess DR-QOL in 46 youth (&lt;20 years old) who underwent TPIAT. The PedsQL™ DM scores were analyzed for statistically significant changes and minimally important clinical differences (MCID) over time post-TPIAT. Scores at 12 months (n = 29) and 24 months (n = 16) were then compared to PedsQL™ DM scores from a historical cohort of demographically similar (age and sex) youth with a 12 months (n = 52) and 24 months (n = 58) after diagnosis of T1D. The diabetes symptoms summary score (mean 65 to 57 and p = 0.03 ) and the total score (mean 74 to 68 and p &lt; 0.05 ) decreased (worsened) during the first 24 months post-TPIAT and met the MCID threshold, suggesting the decrease in these scores was clinically significant. Post-TPIAT PedsQL™ DM scores were not significantly different than youth new diagnosis of T1D after 24 months (all p &gt; 0.2 ). In youth who underwent TPIAT, DR-QOL worsened over the first two years, mostly attributable to the diabetes symptoms score. Compared to children with T1D, post-TPIAT DR-QOL was similar two years after diabetes onset.

1137-P: Improvements in Diabetes-Related Quality of Life (DRQL) and Emotional Distress with Hybrid Closed-Loop (HCL) Technology in Marginalized Families with Suboptimally Controlled Type 1 Diabetes (T1D)

Background: Prior HCL studies enrolling participants with well-controlled T1D and limited financial, racial-ethnic, and socioeconomic diversity have shown limited success in improving patient-reported outcomes (PROs). We evaluated changes in PROs among marginalized youth with T1D and their parents after 6 months of Tandem t:slim X2 insulin pump with Control-IQ technology use. Methods: This non-randomized 6-month pilot study enrolled 15 publicly insured, non-Hispanic Black (NHB) youth with T1D and hemoglobin A1c (HbA1c) ≥10% (Mage 14.6 ± 3.7 yrs, MT1Dduration 8.5 ± 4.8 yrs, MA1c11.9±1.4%). Youth and parent PROs at baseline and 6-months were compared using paired t-tests. The following constructs were assessed using validated PROs: DRQL using T1D and Life (T1DAL), emotional distress using Problem Areas in Diabetes (PAID), positive expectancy of technology using INSPIRE, and self-management behaviors using Diabetes Management Questionnaire (DMQ). Results: Thirteen participants completed the study. HbA1c decreased from 11.7±1.3% to 9.6±1.6% over 6 months (p=0.001). TIDAL scores increased among parents and youth (p-T1DAL +7.1 to 70±13, p=0.01; y-T1DAL +8 to 69±12, p=0.03). PAID scores decreased among parents and youth (p-PAID -25 to 43±30, p=0.01; y-PAID -19.4 to 23±19, p=0.02). There were no changes in parent or child INSPIRE (p=0.23, p=0.88) or DMQ scores (p=0.44, p=0.16). Conclusions: Six months of Tandem t:slim X2 insulin pump with Control-IQ technology in marginalized youth with T1D improved HbA1c, DRQL, and diabetes-related distress among parents and youth despite no change in diabetes self-management behaviors or decrease in positive expectancy of HCL. Including diverse populations in T1D research and supporting equal access to HCL technology for all people with T1D may demonstrate psychosocial benefits with no additional burden for youth and their parents. Disclosure A.G.Perkins: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc. J.Grundman: Research Support; American Diabetes Association, Dexcom, Inc. S.Meighan: Speaker's Bureau; Dexcom, Inc. M.Monaghan: Employee; National Institute of Diabetes and Digestive and Kidney Diseases, Research Support; American Diabetes Association. R.Streisand: None. B.E.Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic. Funding Tandem Diabetes Care, Inc. (TDC20210226); National Institutes of Health (K23DK129827); Dexcom, Inc.

684-P: Momentary, Daily, and Long-Term Impacts of Diabetes on Daily Activities—The Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL-T1D) Study

Introduction: While it is widely recognized that T1D can interfere with daily activities, the extent and impact of these disruptions are poorly understood. Using FEEL-T1D study data, we examined how T1D interfered with daily activities, and the association between activity disruptions, illness intrusiveness, and diabetes-related quality of life (DQoL). Methods: FEEL-T1D prompted 14 days of surveys via smartphone at 3-hr intervals 5-6x/day. At each survey, participants indicated what activity they were doing, their activity performance and satisfaction, and whether/how T1D interfered with the activity. At end-of-day, they noted activities they could not do due to T1D. At study end, participants completed the T1D and Life (T1DAL) measure of DQoL and Adapted Illness Intrusiveness Rating Scale (AIIRS). Descriptive statistics and multilevel regressions were used to identify daily activity disruptions and their associations with DQoL and illness intrusiveness. Results: Overall, 190 participants (40±14 yrs old, 54% female, 29% White, 40% Hispanic/Latinx, 31% other) completed 14,387 momentary surveys, of which 12.1% indicated activity disruptions, most often personal care (16.1% disrupted), sleep (14.6%), and housework/errands (13.4%). Participants were unable to do desired activities due to T1D on 8.2% of days, most often housework/errands (3.8% of days), work/school, personal care, and leisure (2.6% for each). Performance and satisfaction were poorer for disrupted vs. non-disrupted activities (p&amp;lt;.0001). Those with more activity disruptions had greater illness intrusiveness (p&amp;lt;.0001) and lower DQoL (p&amp;lt;.0001). Discussion: T1D-related activity disruptions are common and associated with poorer activity performance/satisfaction, more illness intrusiveness, and lower DQoL. Validating the impact of T1D on daily activities, and seeking strategies to minimize this impact, may improve QoL for adults with T1D. Disclosure E.Pyatak: Research Support; Abbott Diabetes. G.Crespo-ramos: None. R.Hernandez: None. L.T.Pham: None. J.S.Gonzalez: Consultant; Virta Health Corp. D.Spruijt-metz: None. P.Lee: None. S.Schneider: None. A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. J.P.Crandall: Research Support; Abbott Diabetes. S.Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. H.Jin: None. C.J.Hoogendoorn: None. Funding National Institutes of Health (1R01DK121298)

699-P: Neighborhood Disadvantage and Psychosocial Health for Parents of Teens with Type 1 Diabetes (T1D)

Background: The psychosocial health of parents is important to the mental and physical health of teens with T1D, yet living in an area of high neighborhood disadvantage may risk parental psychosocial health due, in part, to increased exposure to stressors and less available support. We explored associations among neighborhood disadvantage and parents’ self-reported psychosocial outcomes among racially, ethnically, and socioeconomically diverse parents of teens with T1D. Methods: At baseline of a 2-site psychosocial intervention trial, 130 parents of teens aged 13-18 with T1D reported on demographic information and their diabetes distress, family conflict, diabetes-related quality of life, and resilience. We retrieved area deprivation index (ADI) scores for home addresses; this measure of neighborhood disadvantage summarizes neighborhood-level income, education, employment, and housing quality via a state-relative decile score ranging from 1-10 (higher scores indicate more disadvantage). Regression analyses were used to examine associations among ADI and psychosocial measures. Results: 130 parents (2% American Indian/Alaska Native, 2% Asian, 8% Black/African American, 10% Latino/Mexican/South or Central American, 81% White; 87% mothers; 73% employed full-time; 78% private Insurance; 59% college graduate or higher) completed surveys. Mean ADI was 3.8±2.7 (range 1-10). Higher neighborhood disadvantage was associated with significantly higher diabetes distress [F(1,127)=13.99, p&amp;lt;.001] and family conflict [F(1,126)=19.42, p&amp;lt;.001] and lower resilience [F(1,127)=4.30, p=.04] and diabetes-related quality of life [F(1,125)=10.42, p=.002]. Conclusions: Consistently poorer psychosocial health among parents in areas with higher neighborhood disadvantage highlights the centrality of social determinants of health to families of teens with T1D. Targeted support for parents in these areas may benefit family T1D management and, ultimately, youth outcomes. Disclosure M.B.O'donnell: None. S.R.Scott: None. B.M.Ellisor: None. S.Garcia perez: None. Y.Rojas: None. F.Malik: None. M.E.Hilliard: None. J.P.Yi-frazier: None. Funding National Institutes of Health (R01DK121224)

Identification of Core Outcome Domains and Design of a Survey Questionnaire to Evaluate Impacts of Digital Health Solutions That Matter to People With Diabetes.

Digital health solutions (DHS) are increasingly used to support people with diabetes (PwD) to help manage their diabetes and to gather and manage health and treatment data. There is a need for scientifically reliable and valid methods to measure the value and impact of DHS on outcomes that matter to PwD. Here, we describe the development of a survey questionnaire designed to assess the perceptions of PwD toward DHS and their prioritized outcomes for DHS evaluation. We applied a structured process for engagement of a total of nine PwD and representatives of diabetes advocacy organizations. Questionnaire development consisted of a scoping literature review, individual interviews, workshops, asynchronous virtual collaboration, and cognitive debriefing interviews. We identified three overarching categories of DHS, which were meaningful to PwD and crucial for the identification of relevant outcomes: (1) online/digital tools for information, education, support, motivation; (2) personal health monitoring to support self-management; (3) digital and telehealth solutions for engaging with health professionals. Overall outcome domains identified to be important were diabetes-related quality of life, distress, treatment burden, and confidence in self-management. Additional positive and negative outcomes specific to DHS were identified and corresponding questions were incorporated into the survey questionnaire. We identified the need for self-reporting of quality of life, diabetes distress, treatment burden, and confidence in self-management, as well as specific positive and negative impacts of DHS. We designed a survey questionnaire to further assess the perceptions and perspectives of people with type 1 and 2 diabetes on outcomes relevant for DHS evaluations.

Associations of Diabetes-related and Health-related Quality of Life With Glycemic Levels in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care

ObjectivesAs adolescents with type 1 diabetes (T1D) progress to adulthood, they assume responsibility for diabetes self-management while dealing with competing life demands, decreasing parental support, and the transfer to adult care. Lower perceived quality of life (QOL) may hamper diabetes management, which is associated with suboptimal glycemic levels. Our objective was to determine associations of diabetes- and health-related QOL with glycemic management (glycated hemoglobin [A1C]) in adolescents with T1D before their transfer to adult care. MethodsWe conducted a cross-sectional analysis of baseline data from the Group Education Trial to Improve Transition (GET-IT- T1D) in adolescents with T1D (16 to 17 years of age). Participants completed validated questionnaires measuring diabetes-related QOL (PedsQL 3.2 Diabetes Module) and health-related QOL (PedsQL 4.0 Generic Core Scales). Associations of QOL Total and subscale scores with A1C were assessed using linear regression models adjusted for sex, diabetes duration, socioeconomic status, insulin pump use, and mental health comorbidity. ResultsOne hundred fifty-three adolescents with T1D were included (mean age, 16.5 [standard deviation, 0.3] years). Diabetes-related QOL Total scores (adjusted β=−0.04; 95% confidence interval [CI], −0.05 to −0.02) as well as subscale scores for Diabetes Symptoms (adjusted β=−0.02; 95% CI, −0.04 to −0.00) and Diabetes Management (adjusted β=−0.04; 95% CI, −0.05 to −0.02) were inversely associated with A1C. Health-related QOL Total scores were not associated with A1C, but Psychosocial Health subscale scores were (adjusted β=−0.01; 95% CI, −0.03 to −0.00). ConclusionOur results suggest that strategies focussing on diabetes-related QOL and psychosocial health may help prepare adolescents for the increasing responsibility of diabetes self-care.

Sedentary Behavior and Physical Activity Associated with Psychosocial Outcomes in Adolescents with Type 1 Diabetes.

Adolescents with type 1 diabetes (T1D) are particularly vulnerable to poor psychosocial outcomes-high rates of diabetes distress and poor quality of life are common among this cohort. Previous work in the general population demonstrated positive associations between quality of life and increases in moderate-to-vigorous physical activity (MVPA), as well as decreased sedentary behavior. While survey-based assessments of young adults with T1D observed similar trends, these studies were limited by their use of subjective assessments of MVPA and sedentary behavior. The use of direct activity monitoring is needed to establish the association between psychosocial outcomes and MVPA and sedentary behavior among adolescents with T1D. To explore the association between objectively measured MVPA and sedentary behavior on psychosocial outcomes among adolescents with T1D. The current study is a secondary analysis of baseline data collected for a pilot trial of sleep-promoting intervention for adolescents with T1D. Participants (n = 29, with a mean age of 15.9 ± 1.3 years) completed baseline surveys and wore an actigraph for a week following the baseline visit. We examined minutes per week of MVPA and proportion of awake time spent sedentary in relation to adolescents' diabetes distress, depressive symptoms, and diabetes-related quality of life. Participants engaged in a mean of 19.6 ± 22.4 minutes of MVPA per day and spent 68.6 ± 9.9% of their awake time sedentary. MVPA was associated with lower diabetes distress in unadjusted (-3.6; 95% CI: -6.4 to -0.8) and adjusted (-2.6; 95% CI: -5.0--0.3) analyses. Sedentary time was associated with higher diabetes distress in adjusted (6.3; 95% CI: 1.3-11.2) but not unadjusted (6.0; 95% CI: -5.6-12.6) analyses. In secondary analyses, we did not observe significant associations between quality of life or depressive symptoms with either MVPA or sedentary behavior. Our findings extend previous survey-based work demonstrating an association between decreased diabetes distress with greater weekly MVPA and lower sedentary time. The current study highlights the multifaceted benefits of physical activity in this population and provides preliminary evidence for developing interventions to reduce sedentary time as an alternative method to improve psychosocial outcomes in this at-risk population.

Impact of Overnight Glucose on Next-Day Functioning in Adults With Type 1 Diabetes: An Exploratory Intensive Longitudinal Study.

While there is evidence that functioning, or ability to perform daily life activities, can be adversely influenced by type 1 diabetes, the impact of acute fluctuations in glucose levels on functioning is poorly understood. Using dynamic structural equation modeling, we examined whether overnight glucose (coefficient of variation[CV], percent time <70 mg/dL, percent time >250 mg/dL) predicted seven next-day functioning outcomes (mobile cognitive tasks, accelerometry-derived physical activity, self-reported activity participation) in adults with type 1 diabetes. We examined mediation, moderation, and whether short-term relationships were predictive of global patient-reported outcomes. Overall next-day functioning was significantly predicted from overnight CV (P = 0.017) and percent time >250 mg/dL (P = 0.037). Pairwise tests indicate that higher CV is associated with poorer sustained attention (P = 0.028) and lower engagement in demanding activities (P = 0.028), time <70 mg/dL is associated with poorer sustained attention (P = 0.007), and time >250 mg/dL is associated with more sedentary time (P = 0.024). The impact of CV on sustained attention is partially mediated by sleep fragmentation. Individual differences in the effect of overnight time <70 mg/dL on sustained attention predict global illness intrusiveness (P = 0.016) and diabetes-related quality of life (P = 0.036). Overnight glucose predicts problems with objective and self-reported next-day functioning and can adversely impact global patient-reported outcomes. These findings across diverse outcomes highlight the wide-ranging effects of glucose fluctuations on functioning in adults with type 1 diabetes.

Sleep quality and sex-related factors in adult patients with immune-mediated diabetes: a large cross-sectional study

AimTo analyze sleep quality and its relationships with clinical and biochemical features in a large cohort of adults with autoimmune diabetes.MethodsWe administered to 553 patients with autoimmune diabetes the questionnaires: Pittsburgh Sleep Quality Index (PSQI), diabetes distress scale, diabetes-related quality of life and diabetes treatment satisfaction questionnaire. We excluded patients with missing HbA1c ± 4 months from PSQI administration or incorrect PSQI compilation (n = 110).ResultsAltered sleep quality was recorded in 142/443 subjects (32%), insufficient total sleep time in 177/443 (40%). The altered sleep quality group had higher HbA1c (median 56 mmol/mol [interquartile range-IQR 49–62] vs 59 [IQR 52–68]; P < 0.001), higher average HbA1c in the previous 36 months (59 mmol/mol [IQR 54–68] vs 56 [IQR 51–62]; P < 0.001), and more individuals with HbA1c > 53 mmol/mol (74.6% vs 62.8%; P = 0.014). Diabetes duration (P = 0.63), type of insulin delivery (P = 0.48) and glucose monitoring (P = 0.35) were uninfluential. Patients with altered sleep quality showed higher prevalence of autoimmune (42 vs 28%; P = 0.005) and mental diseases (12 vs 4%; P = 0.002); there were greater emotional distress, and lower quality of life and treatment satisfaction (P < 0.001 for all), irrespective of sex. Men with altered sleep quality had higher HbA1c and prevalence of autoimmune diseases. Women showed greater prevalence of psychiatric disorders. Average HbA1c of the previous 36 months, autoimmune or psychiatric disorders were independent predictive factors for altered sleep quality.ConclusionOne-third of the patients with autoimmune diabetes showed altered sleep quality, which associates with worse glycemic control, and autoimmune and mental disorders, with sex-specific differences.

Diabetes Technology and the Human Factor.

Diabetes Technology and the Human Factor.

Applying the use of shared medical appointments (SMAs) to improve continuous glucose monitor (CGM) use, glycemic control, and quality of life in marginalized youth with type 1 diabetes: Study protocol for a pilot prospective cohort study

BackgroundContinuous glucose monitors (CGMs) have been associated with improved glycemic control and diabetes-related quality of life in youth with type 1 diabetes (T1D), however use is lowest among youth from low-income households and racial/ethnic minorities. Shared medical appointments (SMAs) have been shown to improve glycemic control and reduce diabetes distress in adolescents with T1D, but a focus on marginalized youth has been lacking. This prospective cohort pilot study will assess feasibility and acceptability of the SMA intervention and impact on CGM uptake and sustained use, glycemic control, and diabetes distress in marginalized youth with elevated hemoglobin A1c (HbA1C). MethodsThe pilot study will recruit 20 publicly insured youth with T1D aged 8–12 years who identify as non-Hispanic Black or Latinx and have had at least one HbA1C value > 8% in the past year and their primary caretaker. The trial will employ an enrollment visit, SMA visits every 3 months over a 12-month study period, and a 6-month follow-up observational period. Feasibility measures include proportion of eligible youth successfully recruited for participation, proportion initiating CGM, SMA attendance, and retention through study completion. Acceptability will be assessed using satisfaction surveys. Changes in glycemic control will be assessed using CGM metrics and A1c from baseline to completion of the 12-month SMA intervention, as well as 3 and 6-months after completion of the SMA intervention. ConclusionImplementing SMAs for marginalized youth has the potential to address diabetes disparities by optimizing clinical and psychosocial outcomes for the most vulnerable youth living with T1D.Trial Registration: https://clinicaltrials.gov/ct2/show/NCT05431686.

The Diabetes teleMonitoring of patients in insulin Therapy (DiaMonT) trial: study protocol for a randomized controlled trial

BackgroundThe effect of telemedicine solutions in diabetes remains inconclusive. However, telemedicine studies have shown a positive trend in regards to glycemic control. The telemedicine interventions that facilitate adjustment of medication seems to improve glycemic control more effectively. Hence, it is recommended that future telemedicine studies for patients with diabetes include patient-specific suggestions for changes in medicine. Hence, the aim of the trial is to explore the effect of telemonitoring in patients with type 2 diabetes (T2D) on insulin therapy.MethodsThe trial is an open-label randomized controlled trial with a trial period of 3 months conducted in two sites in Denmark. Patients with T2D on insulin therapy will be randomized (1:1) to a telemonitoring group (intervention) or a usual care group (control). The telemonitoring group will use a continuous glucose monitor (CGM), an insulin pen, an activity tracker, and smartphone applications throughout the trial. Hospital staff will monitor the telemonitoring group and contact the subjects by telephone repeatedly throughout the trial period. The usual care group will use a blinded CGM the first and last 20 days of the trial and will use a blinded insulin pen for the entire period.The primary endpoint will be changed from baseline in CGM time in range (3.9–10.0 mmol/L) 3 months after randomization. Secondary endpoints include change from baseline in glycated hemoglobin (HbA1c), total daily dose, time above range, and time below range 3 months after randomization. Exploratory endpoints include health-related quality of life, diabetes-related quality of life, etc.DiscussionThe DiaMonT trial will test a telemonitoring setup including various devices. Such a setup may be criticized, because it is impossible to determine which element(s) add to the potential effect. However, it is not possible and counterproductive to test the elements individually, since it is the full telemedicine setup that is being evaluated. The DiaMonT trial is the first Danish trial to explore the effect of telemonitoring on patients on insulin therapy. Thus, the DiaMonT trial has the potential to form the basis for the implementation of telemedicine for patients with T2D in Denmark.Trial registrationClinicalTrials.gov NCT04981808. Registered on 8 June 2021.

Real-Time Continuous Glucose Monitoring in Adolescents and Young Adults With Type 2 Diabetes Can Improve Quality of Life.

Real-time continuous glucose monitoring (CGM) is effective for diabetes management in cases of type 1 diabetes and adults with type 2 diabetes (T2D) but has not been assessed in adolescents and young adults (AYAs) with T2D. The objective of this pilot interventional study was to assess the feasibility and acceptability of real-time CGM use in AYAs with T2D. Adolescents and young adults (13-21 years old) with T2D for six months or more and hemoglobin A1c (A1c) greater than 7%, on any Food and Drug Administration-approved treatment regimen, were included. After a blinded run-in period, participants were given access to a real-time CGM system for 12 weeks. The use and acceptability of the real-time CGM were evaluated by sensor usage, surveys, and focus group qualitative data. Participants' (n = 9) median age was 19.1 (interquartile range [IQR] 16.8-20.5) years, 78% were female, 100% were people of color, and 67% were publicly insured. Baseline A1c was 11.9% (standard deviation ±2.8%), with median diabetes duration of 2.5 (IQR 1.4-6) years, and 67% were using insulin. Seven participants completed the study and demonstrated statistically significant improvement in diabetes-related quality of life, with the mean Pediatric Quality of Life inventory (PedsQL) diabetes score increasing from 70 to 75 after using CGM (P = .026). Focus group results supported survey results that CGM use among AYAs with T2D is feasible, can improve quality of life, and has the potential to modify behavior. Real-time CGM is feasible and acceptable for AYAs with T2D and may improve the quality of life of patients with diabetes. Larger randomized controlled trials are needed to assess the effects on glycemic control and healthy lifestyle changes.

Quality of life and psychological well-being among children and adolescents with diabetes and their caregivers using open-source automated insulin delivery systems: Findings from a multinational survey

BackgroundOpen-source automated insulin delivery (AID) systems have shown to be safe and effective in children and adolescents with type 1 diabetes (T1D) in real-world studies. However, there is a lack of evidence on the effect on their caregivers’ quality-of-life (QoL) and well-being. The aim of this study was to assess the QoL of caregivers and children and adolescents using open-source AID systems using validated measures. MethodsIn this cross-sectional online survey we examined the caregiver-reported QoL and well-being of users and non-users. Validated questionnaires assessed general well-being (WHO-5), diabetes-specific QoL (PAID, PedsQL) and sleep quality (PSQI). Results168 caregivers from 27 countries completed at least one questionnaire, including 119 caregivers of children using open-source AID and 49 not using them. After inclusion of covariates, all measures but the PAID and one subscale of the PedsQL showed significant between-group differences with AID users reporting higher general (WHO-5: p = 0.003), sleep-related (PSQI: p = 0.001) and diabetes-related QoL (PedsQL: p < 0.05). ConclusionsThe results show the potential impact of open-source AID on QoL and psychological well-being of caregivers and children and adolescents with T1D, and can therefore help to inform academia, regulators, and policymakers about the psychosocial health implications of open-source AID.