scholarly journals A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial (Preprint)

2021 ◽  
Author(s):  
Catherine Stanger ◽  
Tobias Kowatsch ◽  
Haiyi Xie ◽  
Inbal Nahum-Shani ◽  
Frances Lim-Liberty ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Young Adults ◽  
Glycemic Control ◽  
Randomized Trial ◽  
Health Coaching ◽  
Mobile App ◽  
Self Management ◽  
Target Range ◽  
Secondary Outcomes

BACKGROUND Many young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve target range glycemic control. Few interventions, however, have been developed specifically for this age group. OBJECTIVE In this randomized trial, we will provide a mobile app (SweetGoals) to all participants as a “core” intervention. The app prompts participants to upload data from their diabetes devices weekly to a device-agnostic uploader (Glooko), automatically retrieves uploaded data, assesses daily and weekly self-management goals, and generates feedback messages about goal attainment. Further, the trial will test two unique intervention components: (1) incentives to promote consistent daily adherence to goals, and (2) web health coaching to teach effective problem solving focused on personalized barriers to self-management. We will use a novel digital direct-to-patient recruitment method and intervention delivery model that transcends the clinic. METHODS A 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A<sub>1c</sub> ≥ 8.0%. All participants will receive the SweetGoals app that tracks and provides feedback about two adherence targets: (a) daily glucose monitoring; and (b) mealtime behaviors. Participants will be randomized to the factorial combination of incentives and health coaching. The intervention will last 6 months. The primary outcome will be reduction in A<sub>1c</sub>. Secondary outcomes include self-regulation mechanisms in longitudinal mediation models and engagement metrics as a predictor of outcomes. Participants will complete 6- and 12-month follow-up assessments. We hypothesize greater sustained A<sub>1c</sub> improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components. RESULTS Data collection is expected to be complete by February 2025. Analyses of primary and secondary outcomes are expected by December 2025. CONCLUSIONS Successful completion of these aims will support dissemination and effectiveness studies of this intervention that seeks to improve glycemic control in this high-risk and understudied population of young adults with T1D. CLINICALTRIAL ClinicalTrials.gov NCT04646473; https://clinicaltrials.gov/ct2/show/NCT04646473 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/27109

scholarly journals A Digital Health Intervention (SweetGoals) for Young Adults With Type 1 Diabetes: Protocol for a Factorial Randomized Trial

10.2196/27109 ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. e27109
Author(s):  
Catherine Stanger ◽  
Tobias Kowatsch ◽  
Haiyi Xie ◽  
Inbal Nahum-Shani ◽  
Frances Lim-Liberty ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Young Adults ◽  
Glycemic Control ◽  
Randomized Trial ◽  
Health Coaching ◽  
Mobile App ◽  
Self Management ◽  
Target Range ◽  
Secondary Outcomes

Background Many young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve target range glycemic control. Few interventions, however, have been developed specifically for this age group. Objective In this randomized trial, we will provide a mobile app (SweetGoals) to all participants as a “core” intervention. The app prompts participants to upload data from their diabetes devices weekly to a device-agnostic uploader (Glooko), automatically retrieves uploaded data, assesses daily and weekly self-management goals, and generates feedback messages about goal attainment. Further, the trial will test two unique intervention components: (1) incentives to promote consistent daily adherence to goals, and (2) web health coaching to teach effective problem solving focused on personalized barriers to self-management. We will use a novel digital direct-to-patient recruitment method and intervention delivery model that transcends the clinic. Methods A 2x2 factorial randomized trial will be conducted with 300 young adults ages 19-25 with type 1 diabetes and (Hb)A1c ≥ 8.0%. All participants will receive the SweetGoals app that tracks and provides feedback about two adherence targets: (a) daily glucose monitoring; and (b) mealtime behaviors. Participants will be randomized to the factorial combination of incentives and health coaching. The intervention will last 6 months. The primary outcome will be reduction in A1c. Secondary outcomes include self-regulation mechanisms in longitudinal mediation models and engagement metrics as a predictor of outcomes. Participants will complete 6- and 12-month follow-up assessments. We hypothesize greater sustained A1c improvements in participants who receive coaching and who receive incentives compared to those who do not receive those components. Results Data collection is expected to be complete by February 2025. Analyses of primary and secondary outcomes are expected by December 2025. Conclusions Successful completion of these aims will support dissemination and effectiveness studies of this intervention that seeks to improve glycemic control in this high-risk and understudied population of young adults with T1D. Trial Registration ClinicalTrials.gov NCT04646473; https://clinicaltrials.gov/ct2/show/NCT04646473 International Registered Report Identifier (IRRID) PRR1-10.2196/27109

scholarly journals A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Pamela Martyn-Nemeth ◽  
Jennifer Duffecy ◽  
Laurie Quinn ◽  
Chang Park ◽  
Dan Mihailescu ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Young Adults ◽  
Glycemic Control ◽  
Behavioral Therapy ◽  
Attention Control ◽  
Self Management ◽  
Control Group ◽  
Fear Of Hypoglycemia ◽  
Attention Control Group

Abstract Background In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings). Methods/design A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups. Discussion Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV. Trial registration ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018

scholarly journals Remote monitoring of adolescents with type 1 diabetes mellitus using a mobile application

2022 ◽  
Vol 24 (5) ◽  
pp. 404-413
Author(s):  
D. N. Laptev ◽  
I. A. Eremina ◽  
A. V. Karpushkina ◽  
E. E. Petryaykina ◽  
O. B. Bezlepkina ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Type 1 Diabetes Mellitus ◽  
Mobile Application ◽  
Mobile App ◽  
Target Range

Background: The prevalence of type 1 diabetes mellitus (T1DM) in childhood is increasing every year. Adolescence is the most challenging age for achieving optimal metabolic control of T1DM. Telemedicine has already been shown to be ­effective in children with the condition, but there are not enough studies in adolescents. The use of mobile apps may be associated with better glycemic control in patients with type 1 diabetes.Aims: To assess the effectiveness and safety of a model of medical care for adolescents with type 1 diabetes using remote counseling and a mobile application.Materials and methods: Were included adolescents aged ≥14 and 18 years with a T1DM duration> 3 months, a glycated hemoglobin level (HbA1c)> 7%. The duration of the study was 26 weeks. There were 3 face-to-face and at least 4 remote visits using a mobile application. All patients underwent standard examination and anthropometry, study of HbA1c, registration and analysis of indicators, assessment and correction of the treatment. The quality of life of adolescents was assessed at baseline and at the end of the study. Adolescents and physicians were interviewed about program evaluation.Results: 56 patients were included, 7 adolescents withdrew. HbA1c significantly decreased by the 12th week of the study (–0.3%; p = 0.005), by the end of the study the change in HbA1c was –0.5% (p <0.001). There was an increase in the percentage of glucose measurements in the target range (+5.3 pp; p = 0.016) and a decrease in blood glucose variability (-3.1 pp; p =  0.015). There was a significant improvement in both the total assessment of the quality of life by patients (+2.9 points; p = 0.008) and individual components of its indicators: attitude to diabetes (+3.0 points; p = 0.049), attitude to treatment (+4.6 points; p = 0.010) and communication with others (+4.5 points; p = 0.015). The majority of doctors and patients assessed their participation in the study positively. The incidence of adverse events did not change significantly during the study from baseline.Conclusion: Remote counseling using a mobile app is a safe and effective approach for adolescents with T1DM in terms of glycemic control and quality of life, and provides convenience and speed of interaction.

803-P: Modifiable Diabetes-Specific Factors and Glycemic Control in Economically Vulnerable and Racial/Ethnic Minority Young Adults with Type 1 Diabetes

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 803-P
Author(s):  
SHIVANI AGARWAL ◽  
LAUREN KANAPKA ◽  
JENNIFER RAYMOND ◽  
ASHBY F. WALKER ◽  
ANDREA GERARD GONZALEZ ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Young Adults ◽  
Glycemic Control ◽  
Ethnic Minority ◽  
Specific Factors ◽  
Racial Ethnic

scholarly journals Feasibility study of real-time online text-based CBT to support self-management for people with type 1 diabetes: the Diabetes On-line Therapy (DOT) Study

2021 ◽  
Vol 9 (1) ◽  
pp. e001934
Author(s):  
Anne M Doherty ◽  
Anne Herrmann-Werner ◽  
Arann Rowe ◽  
Jennie Brown ◽  
Scott Weich ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Real Time ◽  
Instant Messaging ◽  
Controlled Trial ◽  
Self Management ◽  
Diabetes Distress ◽  
The Mean ◽  
Distress Scale

IntroductionThis study examines the feasibility of conducting diabetes-focused cognitive–behavioral therapy (CBT) via a secure online real-time instant messaging system intervention to support self-management and improve glycemic control in people with type 1 diabetes.Research design and methodsWe used a pre–post uncontrolled intervention design over 12 months. We recruited adults with type 1 diabetes and suboptimal glycemic control (HbA1c ≥69 mmol/mol (DCCT 8.5%) for 12 months) across four hospitals in London. The intervention comprised 10 sessions of diabetes-focused CBT delivered by diabetes specialist nurses. The primary outcomes were number of eligible patients, rates of recruitment and follow-up, number of sessions completed and SD of the main outcome measure, change in HbA1c over 12 months. We measured the feasibility of collecting secondary outcomes, that is, depression measured using Patient Health Questionnaire-9 (PHQ-9), anxiety measured Generalised Anxiety Disorder (GAD) and the Diabetes Distress Scale (DDS).ResultsWe screened 3177 patients, of whom 638 were potentially eligible, from whom 71 (11.1%) were recruited. The mean age was 28.1 (13.1) years, and the mean HbA1c was 84.6 mmol/mol (17.8), DCCT 9.9%. Forty-six (65%) patients had at least 1 session and 29 (41%) completed all sessions. There was a significant reduction in HbA1c over 12 months (mean difference −6.2 (2.3) mmol/mol, DCCT 0.6%, p=0.038). The change scores in PHQ-9, GAD and DDS also improved.ConclusionsIt would be feasible to conduct a full-scale text-based synchronized real-time diabetes-focused CBT as an efficacy randomized controlled trial.

Health promotion challenges for young adults living with intellectual disability and type 1 diabetes

2021 ◽  
pp. 174462952110327
Author(s):  
Anne L Marks ◽  
Natasha Mahoney ◽  
Yu-Wei Chen ◽  
Reinie Cordier ◽  
Angus Buchanan ◽  
...  
Keyword(s):  
Health Promotion ◽  
Type 1 Diabetes ◽  
Young Adults ◽  
Intellectual Disability ◽  
Barriers And Facilitators ◽  
Self Management ◽  
Service Support ◽  
Health Support ◽  
Level Monitoring

Background: Self-management of type 1 diabetes mellitus (T1DM) can be challenging for people with intellectual disability. Often, parents provide health support due to lack of appropriate services outside the home. The study aim was to identify barriers and facilitators to T1DM self-management for young adults with intellectual disability and the implications for health promotion. Methods: Five male participants with intellectual disability, aged 17–26 years, and seven parents were interviewed between October 2017 and February 2019. Interview data were descriptively analysed. Findings: Two categories for barriers and facilitators were identified: 1) Diabetes self-management is complex (carbohydrate counting, blood glucose level monitoring, insulin therapy); 2) support for diabetes care (reliance on parents and carers, the National Disability Insurance Scheme, mainstream diabetes service support). Conclusions: Parents are critical for the support of people with intellectual disability and T1DM in the absence of disability staff with appropriate health skills.

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