Satisfaction with diabetes involvement: Exploring parent and adolescent perspectives.

AIMS: Both parent and adolescent involvement in type 1 diabetes management are critical during adolescence. The current study sought to understand the factors associated with parent and adolescent satisfaction with their own and one another's involvement in diabetes management. METHODS: Cross-sectional baseline data from 157 parent-adolescent dyads enrolled in an RCT were used. Adolescent ages ranged from 12 to 19 (Mage = 14.7, SD = 1.89) and were balanced by gender (50.3% male). Paired t-tests examined concordance between parent and adolescent satisfaction, bivariate correlations identified correlates, and regressions examined unique associations. RESULTS: Roughly, 43% of adolescents and 29% of parents were very satisfied with adolescent involvement in diabetes management, whereas 71% of adolescents and 26.1% of parents were very satisfied with parent involvement. Indicators of better glycaemic health (via higher percent time-in-range and lower HbA1c and percent time in hyperglycaemia) and psychosocial functioning (less diabetes distress and depression) were correlated with higher satisfaction. Parent satisfaction with adolescent involvement was higher among older adolescents (R = 0.198, p = 0.013). Non-Hispanic white youth were more satisfied with their own involvement than youth of colour (t(149) = -2.783, p = 0.003). Both percent time-in-range and one's own diabetes distress uniquely related to parent and adolescent satisfaction with adolescent involvement. Conversely, parent satisfaction with their own involvement was only uniquely associated with parent diabetes distress. CONCLUSION: Both adolescent and parents' satisfaction with adolescents' involvement in self-management are indicators of both glycaemic control and psychosocial well-being, whereas parents' self-evaluations are more closely tied to diabetes-specific distress.

"It changed everything we do": A mixed methods study of youth and parent experiences with a pilot exercise education intervention following new diagnosis of type 1 diabetes.

AIMS: This pilot study delivered a comprehensive exercise education intervention to youth with new-onset type 1 diabetes (T1D) and their parents to increase knowledge and confidence with physical activity (PA) shortly after diagnosis. METHODS: Youth initiated continuous glucose monitoring (CGM) and PA trackers within 1 month of diagnosis. Youth and their parents received the 4-session intervention over 12 months. Participants completed self-report questionnaires at baseline, 6- and 12-months. Surveys were analyzed using linear mixed effects models. Semi-structured interviews and focus groups explored experiences with the exercise education intervention. Groups and interviews were audio-recorded, transcribed, and analyzed using content analysis. RESULTS: A total of 16 parents (aged 46 ± 7 years; 88 % female; 67 % non-Hispanic White) and 17 youth (aged 14 ± 2 years; 41 % female; 65 % non-Hispanic White) participated. Worry about hypoglycemia did not worsen throughout the study duration. Parents and youth reported increased knowledge and confidence in managing T1D safely and preventing hypoglycemia during PA following receiving the tailored exercise education intervention. CONCLUSION: This study assessed a novel structured exercise education program for youth and their parents shortly following T1D diagnosis. These results support the broad translation and acceptability of a structured exercise education program in new-onset T1D.

Evaluation of a novel eating disorder prevention program for young women with type 1 diabetes: A preliminary randomized trial.

OBJECTIVE: Evaluate whether the Body Project prevention program adapted for young women with type 1 diabetes (Diabetes Body Project) reduces eating disorder (ED) risk factors and symptoms. METHODS: Young women (aged 15-30) at high-risk for EDs due to having type 1 diabetes and body image concerns (N = 55) were randomized to virtually delivered Diabetes Body Project groups or an educational control condition, completing measures at pretest, posttest, and 3-month follow-up. RESULTS: Diabetes Body Project versus the control participants showed significantly greater reductions in thin-ideal internalization, body dissatisfaction, diabetes distress, diabetes eating pathology, and ED symptoms by posttest, and greater reductions in diabetes eating pathology and ED symptoms, and greater improvements in quality of life by 3-month follow-up, which were medium to large effects (d's ranged from -0.43 to -0.90). Although control participants showed a worsening of glycemic control (time in range) verses Diabetes Body Project participants, this difference was non-significant (d = 0.26). CONCLUSIONS: Virtually delivered Diabetes Body Project decreased ED risk factors and symptoms in young women with type 1 diabetes. A well powered randomized controlled trial is warranted to evaluate this intervention over longer follow-up.

Expanding the use of patient-reported outcomes (PROs): Screening youth with type 1 diabetes from underrepresented populations.

AIM: Youth from lower socioeconomic status (SES) have suboptimal type 1 diabetes (T1D) outcomes. Patient reported outcomes (PROs) measure psychosocial states and are associated with T1D outcomes, however are understudied in low SES youth. We aimed to evaluate associations between PROs and public insurance status, a proxy for low SES. METHODS: We analyzed survey data from 129 youth with T1D (age 15.7 ± 2.3 years, 33 % publicly insured) screened with PROMIS Global Health (PGH, measuring global health) and Patient Health Questionnaire (PHQ-9, measuring depressive symptoms) during diabetes appointments. Correlation and regression analyses evaluated differences in PGH and PHQ-9 by insurance status. RESULTS: For youth with public insurance, lower global health correlated with lower self-monitoring blood glucose (SMBG; r = 0.38,p = 0.033) and older age (r = -0.45,p = 0.005). In youth with private insurance, lower global health correlated with lower SMBG (r = 0.27,p = 0.018) and female sex (rho = 0.26,p = 0.015). For youth with private insurance, higher depressive symptoms correlated with higher body mass index (r = 0.22,p = 0.03) and fewer SMBG (r = -0.35,p = 0.04). In multivariate regression analyses, public insurance was inversely associated with global health (p = 0.027). CONCLUSION: PGH is a particularly salient PRO in youth with public insurance. Global health may be an important psychosocial factor to assess in youth with T1D from low SES backgrounds.

DiabetesWise: An innovative approach to promoting diabetes device awareness.

BACKGROUND: DiabetesWise is an unbranded, data-driven online resource that tailors device recommendations based on preferences and priorities of people with insulin-requiring diabetes. The objective of this study is to examine whether DiabetesWise increases uptake of diabetes devices, which are empirically supported to improve glycemic and psychosocial outcomes. METHODS: The sample included 458 participants (Mage = 37.1, SD = 9.73; 66% female; 81% type 1 diabetes) with insulin-requiring diabetes and minimal diabetes device use at enrollment. Participants used DiabetesWise and completed online surveys. Chi-square and t tests evaluated requests for a device prescription, receiving a prescription, and starting a new device at 1 and 3 months post use. Baseline predictors of these variables and past use of continuous glucose monitors (CGMs) and changes in diabetes distress post use were also examined. RESULTS: Within the first month of interacting with DiabetesWise 19% of participants asked for a prescription for a diabetes device. This rate rose to 31% in the first 3 months. These requests resulted in 16% of the sample starting a new device within the first 3 months. Whereas several factors were associated with prior CGM use, receiving a prescription, and starting a new device, more diabetes distress (t(343) = -3.13, p = .002) was the only factor associated with asking for a prescription. Diabetes distress decreased after interacting with DiabetesWise within 1 month (t(193) = 3.51, p < .001) and 3 months (t(180) = 5.23, p < .001). CONCLUSIONS: Within 3 months of interacting with DiabetesWise, one in three participants had requested a prescription for a new diabetes device and average distress levels were reduced, indicating benefit from this low-intensity online platform.

Psychosocial Effects of the Loop Open-Source Automated Insulin Delivery System.

AIMS: This study examined the psychosocial impact of Loop, an open-source automated insulin dosing system that has emerged from the diabetes technology "Do-It-Yourself" (DIY) movement. METHODS: Subsamples of 239 adults, 115 children, and 243 parents completed data collection at the time of Loop initiation and 3 and 6 months later. Surveys collected demographic and clinical information, percent time-in-range, HbA1c, and validated psychosocial measures. Analyses included paired t tests and McNemar's tests to compare psychosocial functioning at 3 and 6 months and regression models to assess baseline predictors of psychosocial outcomes at 6 months. RESULTS: Adults reported significant improvements in diabetes distress (t = -7.20 P < .001; t = -8.01, P < .001), sleep quality (t = 6.81, P < .001; t = 2.98, P = .003), fear of hypoglycemia (t = -4.42, P < .001; t = -4.97, P < .001), and hypoglycemia confidence (t = 8.68, P < .001; t = 7.96 P < .001) from baseline to 3 months and 6 months, respectively. Significant improvements in parents' and children's sleep quality and parents' fear of hypoglycemia were also observed. Several baseline characteristics were associated with psychosocial outcomes at 6 months. CONCLUSIONS: The current findings support the broad and sustained benefits of Loop across multiple aspects of psychosocial well-being. Advancement and dissemination of such technologies has the potential to improve mental and physiological health among people living with type 1 diabetes.

Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents.

AIM: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. MATERIALS AND METHODS: The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. RESULTS: In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p < .05) and focus group responses. There were no negative effects of CL use reported by study participants. CONCLUSIONS: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience.

Qualitative Study of User Experiences with Loop, an Open-Source Automated Insulin Delivery System.

Background: Loop is an open-source automated insulin delivery (AID) system, used by more than 9,000 people with type 1 diabetes. Understanding the pros and cons of Loop use may help improve disease management and support population level innovation. Methods: Focus groups revealed 72 new and existing users' perspectives on Loop uptake, use, and persistence. A subsample of participants from a mixed-methods, observational cohort study shared first-hand accounts of their experiences using Loop. Participants were predominately white (95%), male (50%), privately insured (94%), and reported annual household income ≥$100K (73%) and education exceeding a bachelor's degree (87%) with a mean HbA1c of 6.6% ± 0.8%. Data were analyzed and synthesized by a multidisciplinary team. Results: Participants detailed their experiences with (1) Loop technical support and troubleshooting, (2) decreased mental/behavioral burden, (3) technical issues with parts of the system, (4) glycemic control, (5) personalizing settings, and (6) providers while using Loop. Decreased burden was the most endorsed benefit defined by less worry, stress, and cognitive effort and less time spent on diabetes management tasks. Participants highlighted the benefits of Loop overnight and their introduction to "Loop communities" during use. The most discussed challenges involved technical issues. A range of provider attitudes and knowledge about Loop complicated users' clinical experiences and disclosure. Conclusions: This sample of new and experienced Loop users reported benefits to quality of life and glycemic control that outweighed challenges of setting up system components, customizing the system to suit one's lifestyle and habits, and adjusting system settings. Challenges related to system setup and calibrating settings are remediable and, if addressed, may better serve Loop users. Users reported feeling empowered by the customizability of and the educational effects facilitated by the open-source AID system. Loop helped users learn more about their chronic illness and physiology in an acceptable format. Clinical Trial Registration number: NCT03838900.

Discontinued Use of the Loop Insulin Dosing System: A Mixed-Methods Investigation.

Background: Loop is an open-source automated insulin dosing system that allows users unrivaled control over system settings that affect future glucose prediction. Thousands use Loop, but little is known about those who discontinue. Methods: In a large observational study, 874 Loop participants completed surveys and provided glycemic data, 46 (5.3%) of those self-identified as discontinuing Loop use during the observation window, 45 completed a discontinued use survey, 22 provided system settings data, and 19 participated in semistructured interviews about their discontinuation. Qualitative data were transcribed, coded, and analyzed. Results: Older age and not trusting Loop were associated with discontinued use, although no other demographic or clinical characteristics were significant correlates. The most endorsed reasons were "I decided to try something else" (27.8%) followed by "It just didn't help as much as I thought it would" (22.2%). Qualitative analyses revealed prominent themes centered upon mental and emotional burden and adjusting settings. Other reasons for discontinued use included fear of disapproval of Loop use from diabetes provider, barriers to acquiring component devices, a desire to try new/different technologies, concerns that Loop could not accommodate specific exercise or low insulin dose regimens, and worry about Loop use during pregnancy. It was noted that burdens might be alleviated by enhanced technical assistance and expert guidance. Conclusions: Although the majority of individuals in the Loop observational study continued use, those who discontinued reported similar challenges. Technical support and education specific to setting calculations could expand Loop benefits, alleviate burden, and support sustained use among new Loop users. Clinical Trial Registration: clinicaltrials.gov (NCT03838900).

ONBOARD: A Feasibility Study of a Telehealth-Based Continuous Glucose Monitoring Adoption Intervention for Adults with Type 1 Diabetes.

Background: Continuous glucose monitoring (CGM) can improve glycemic control for adults with type 1 diabetes (T1D) but certain barriers interfere with consistent use including cost, data overload, alarm fatigue, physical discomfort, and unwanted social attention. This pilot study aimed to examine feasibility and acceptability of a behavioral intervention, ONBOARD (Overcoming Barriers and Obstacles to Adopting Diabetes Devices) to support adults with T1D in optimizing CGM use. Methods: Adults (18-50 years) with T1D in their first year of CGM use were invited to participate in a tailored, multicomponent telehealth-based intervention delivered over four 60-min sessions every 2-3 weeks. Participants completed surveys (demographics; diabetes distress, Diabetes Distress Scale for adults with type 1 diabetes; satisfaction with program) and provided CGM data at baseline and postintervention (3 months). Data were analyzed using paired t-tests and Wilcoxon signed-rank tests. Results: Twenty-two participants (age = 30.95 ± 8.32 years; 59% women; 91% non-Hispanic; 86% White, 5% Black, 9% other; 73% pump users) completed the study. ONBOARD demonstrated acceptability and a high rate of retention. Moderate effect sizes were found for reductions in diabetes distress (P = 0.01, r = -0.37) and increases in daytime spent in target range (70-180 mg/dL: P = 0.03, r = -0.35). There were no significant increases in hypoglycemia. Conclusions: Findings show preliminary evidence of feasibility, acceptability, and efficacy of ONBOARD for supporting adults with T1D in optimizing CGM use while alleviating diabetes distress. Further research is needed to examine ONBOARD in a larger sample over a longer period.

Provider Implicit Bias Impacts Pediatric Type 1 Diabetes Technology Recommendations in the United States: Findings from The Gatekeeper Study.

BACKGROUND: Diabetes technology use is associated with favorable type 1 diabetes (T1D) outcomes. American youth with public insurance, a proxy for low socioeconomic status, use less diabetes technology than those with private insurance. We aimed to evaluate the role of insurance-mediated provider implicit bias, defined as the systematic discrimination of youth with public insurance, on diabetes technology recommendations for youth with T1D in the United States. METHODS: Multi-disciplinary pediatric diabetes providers completed a bias assessment comprised of a clinical vignette and ranking exercises (n = 39). Provider bias was defined as providers: (1) recommending more technology for those on private insurance versus public insurance or (2) ranking insurance in the top 2 of 7 reasons to offer technology. Bias and provider characteristics were analyzed with descriptive statistics, group comparisons, and multivariate logistic regression. RESULTS: The majority of providers [44.1 ± 10.0 years old, 83% female, 79% non-Hispanic white, 49% physician, 12.2 ± 10.0 practice-years] demonstrated bias (n = 33/39, 84.6%). Compared to the group without bias, the group with bias had practiced longer (13.4±10.4 years vs 5.7 ± 3.6 years, P = .003) but otherwise had similar characteristics including age (44.4 ± 10.2 vs 42.6 ± 10.1, p = 0.701). In the logistic regression, practice-years remained significant (OR = 1.47, 95% CI [1.02,2.13]; P = .007) when age, sex, race/ethnicity, provider role, percent public insurance served, and workplace location were included. CONCLUSIONS: Provider bias to recommend technology based on insurance was common in our cohort and increased with years in practice. There are likely many reasons for this finding, including healthcare system drivers, yet as gatekeepers to diabetes technology, providers may be contributing to inequities in pediatric T1D in the United States.

Do Youth Want Psychosocial Screenings in Diabetes Clinic? Profiles of Acceptability.

AIMS: Psychosocial screenings are recommended and increasingly common in pediatric subspecialty clinics, though little is known about their acceptability. This study seeks to uncover profiles of acceptability and assess demographic and clinical correlates among adolescents with diabetes. METHODS: A sample of 124 adolescents (57.7% female) ages 12-21 years (M = 16.2 ± 2.3) completed screenings during routine diabetes appointments. K-means clustering of responses to acceptability items derived profiles; Analysis of Variance (ANOVA) and Chi-square tests assessed correlates. RESULTS: Adolescents with the most common profile (72.6%) placed high importance on medical providers' awareness of their emotions and reported no difficulties/discomfort with the screener. These youth had moderate depressive symptoms, low diabetes distress, and low A1c. Those who fit a less common profile (18.5%) were uncomfortable with the screener and had the highest depressive symptoms and lowest A1c. Youth who fit a smaller profile (6.5%) endorsed technical difficulties and had high depressive symptoms and lowest diabetes distress. The smallest profile (2.4%, N = 3) had difficulty understanding and experienced discomfort with the screening and had the lowest depressive symptoms and the highest diabetes distress and A1c. These differences in depressive symptoms (F = 3.54, p = .017), A1c values (F = 4.03, p = .009), and diabetes distress (F = 3.27, p = .036) were significant though differences in age, gender, and diabetes duration were not. CONCLUSIONS: Most youth responded favorably to in-clinic psychosocial screenings. Youth who were less satisfied were at increased risk for psychosocial and medical complications. Findings highlight areas of need, such as enhanced support with and an emphasized rationale for screenings, which may improve patient experience in subspecialty care.

Cost, Hassle, and On-Body Experience: Barriers to Diabetes Device Use in Adolescents and Potential Intervention Targets.

Background: Adolescents with diabetes have the highest A1cs of all age groups. Diabetes devices (insulin pumps and continuous glucose monitors [CGM]) can improve glycemic outcomes, and although the uptake of devices has increased, they remain underutilized in this population. This study characterizes adolescent-reported barriers to diabetes device use to determine targets for clinician intervention. Methods: We surveyed 411 adolescents with type 1 diabetes (mean age 16.30 ± 2.25 years) on barriers to diabetes device use, technology use attitudes (general and diabetes specific), benefits and burdens of CGM, self-efficacy for diabetes care, diabetes distress, family conflict, and depression. We characterize barriers to device uptake; assess demographic and psychosocial differences in device users, discontinuers, and nonusers; and determine differences in device use by gender and age. Results: The majority of adolescents used an insulin pump (n = 307, 75%) and more than half used CGM (n = 225, 55%). Cost/insurance-related concerns were the most commonly endorsed barrier category (61%) followed by wear-related issues (58.6%), which include the hassle of wearing the device (38%) and dislike of device on the body (33%). Adolescents who endorsed more barriers also reported more diabetes distress (P = 0.003), family conflict (P = 0.003), and depressive symptoms (P = 0.014). Pump and CGM discontinuers both endorsed more barriers and more negative perceptions of technology than current users, but reported no difference from device users in diabetes distress, family conflict, or depression. Gender was not related to the perceptions of devices. Conclusions: Clinicians can proactively assess attitudes toward diabetes technology and perceptions of benefits/burdens to encourage device uptake and potentially prevent device discontinuation among adolescents.

Parental Perspectives: Identifying Profiles of Parental Attitudes and Barriers Related to Diabetes Device Use.

Background: Despite the demonstrated benefits of diabetes device use, uptake of insulin pumps and continuous glucose monitors (CGMs) remains quite low. The current study aimed to identify profiles of parents of youth with type 1 diabetes based on their attitudes toward diabetes-specific technology and barriers to diabetes technology uptake. Methods: Online survey data were collected from 471 parents in the T1D Exchange Clinic Network (child's age = 12.0 ± 3.2 years; diabetes duration = 7.0 ± 2.9 years; A1c = 8.4% ± 1.3; 75% using insulin pump; 27% using CGM). Results: K-means cluster analyses revealed five parent profiles: Embracers (50.7%), Burdened (15.7%), Hopeful but Hassled (14.2%), Distrusting (12.7%), and Data Minimalists (6.6%). ANOVAs and chi-square tests identified differences between groups based on diabetes distress, worry over hypoglycemia, device use, and demographic characteristics. Conclusions: Providers encouraging device uptake may benefit from tailoring their approaches based on these distinct groups and their corresponding concerns and needs.

Trust in hybrid closed loop among people with diabetes: Perspectives of experienced system users.

Automated closed loop systems will greatly change type 1 diabetes management; user trust will be essential for acceptance of this new technology. This qualitative study explored trust in 32 individuals following a hybrid closed loop trial. Participants described how context-, system-, and person-level factors influenced their trust in the system. Participants attempted to override the system when they lacked trust, while trusting the system decreased self-management burdens and decreased stress. Findings highlight considerations for fostering trust in closed loop systems. Systems may be able to engage users by offering varying levels of controls to match trust preferences.

Depression in context: Important considerations for youth with type 1 vs type 2 diabetes.

BACKGROUND: Youth with diabetes are at increased risk for depression. However, severity and correlates of depressive symptoms may differ by diabetes type. OBJECTIVE: Associations of depressive symptoms with global health, diabetes duration, and gender were compared between youth with type 1 and type 2 diabetes. METHODS: A sample of 149 youth ages 12 to 21 diagnosed with either type 1 (n = 122) or type 2 (n = 27) diabetes were screened during routine clinic appointments. Regression models were constructed to examine differences by diabetes type. RESULTS: Adolescents with type 2 diabetes had significantly higher depressive symptom scores (4.89 vs 2.99, P = .025) than those with type 1 diabetes. A significant interaction between global health and diabetes type on depressive symptoms revealed inverse associations between global health and depressive symptoms that was stronger among youth with type 2 diabetes (ß = -.98, P < .001) than type 1 (ß = -.48, P < .001). Further probing revealed that among youth with better global health, adolescents with type 1 had more depressive symptoms than those with type 2 diabetes (ß = .33, P = .035). Diabetes duration and depressive symptoms were positively associated among individuals with type 2 (ß = .86, P = .043), but not type 1 diabetes. No gender differences were detected. CONCLUSION: These findings suggest that correlates of depressive symptoms in youth with diabetes differ by diabetes type. Global health appears to be an important correlate among youth with both types, whereas diabetes duration was only a significant factor among those with type 2 diabetes. The current findings can inform future psychosocial intervention efforts within both these populations.

Feasibility Studies of an Insulin-Only Bionic Pancreas in a Home-Use Setting.

BACKGROUND: We tested the safety and performance of the "insulin-only" configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points. METHOD: This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis. RESULTS: Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL, P = .004) but not in the dynamic set-point arm (154 ± 10 mg/dL, P = ns). There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms. There was less time <70 mg/dL with both the static (1.8% ± 1.4%, P = .009) and dynamic set-point (2.7±1.5, P = .051) arms compared to the usual-care arm (5.5% ± 4.2%). HF testing demonstrated preliminary user satisfaction and no increased risk of diabetes burden or distress. CONCLUSIONS: The insulin-only configuration of the BP using either static or dynamic set-points and initialized only with body weight performed similarly to other published insulin-only systems.

Optimizing the use of continuous glucose monitoring in young children with type 1 diabetes with an adaptive study design and multiple randomizations.

Parents of young children with type 1 diabetes (T1D) experience unique, developmental challenges in managing their child's T1D, resulting in psychosocial distress. Only a small portion of young children reach glucose goals and adherence to diabetes devices that help improve T1D management have historically been low in this population. The purpose of this study is to test four interventions that couple developmentally tailored behavioral supports with education to optimize use of diabetes devices, improve glucose control, and reduce psychosocial distress for parents of young children with T1D. The study team designed four behavioral interventions, two aimed at improving glucose control and two aimed at optimizing use of diabetes devices. The goal of this paper is to describe the behavioral interventions developed for this study, including the results of a pilot test, and describe the methods and analysis plan to test this intervention strategy with ninety participants in a large-scale, randomized trial using a sequential multiple assignment randomization trial (SMART) design. A SMART design will permit a clinically relevant evaluation of the intervention strategy, as it allows multiple randomizations based on individualized assessments throughout the study instead of a fixed intervention dose seen in most traditional randomized controlled trials.

CGM Benefits and Burdens: Two Brief Measures of Continuous Glucose Monitoring.

BACKGROUND: Continuous glucose monitors (CGM) are underutilized by individuals with type 1 diabetes (T1D), particularly during the adolescent years. Little is known about perceptions of CGM benefit and burdens, and few tools exist to quantify this information. METHODS: Two questionnaires were developed and validated-Benefit of CGM (BenCGM) and Burdens of CGM (BurCGM)-in a sample of adolescents ages 12-19 years involved in the T1D Exchange Registry. We chose to start the validation process with adolescents given their low CGM uptake and high risk for suboptimal glycemic outcomes. Exploratory and confirmatory factor analyses were conducted to confirm factor structure and select items. The resultant scales were tested for internal reliability and convergent/divergent validity with critical diabetes and quality of life outcomes: age, depression, diabetes distress, self-efficacy, technology attitudes, and diabetes technology attitudes. RESULTS: A total of 431 adolescents with T1D completed the questionnaires (51% female, mean age 16.3 ± 2.26, 83% white non-Hispanic, 70% having used CGM). Two single factor scales emerged, and scales were reduced to 8 items each. Those who perceived higher benefit of CGM exhibited lower diabetes distress, higher self-efficacy, and more positive attitudes toward technology. Those who perceived higher burden of CGM exhibited higher diabetes distress, lower self-efficacy, and less positive technology attitudes. CONCLUSION: The BenCGM and BurCGM questionnaires each comprise 8-items that demonstrate robust psychometric properties for use in adolescents with T1D, and can be used to develop targeted interventions to increase CGM wear to improve diabetes management.

Psychosocial and Human Factors During a Trial of a Hybrid Closed Loop System for Type 1 Diabetes Management.

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.