Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)

Type 1 Diabetes Clinical Trial

Official title:

Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults With T1D: Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05413239
• Other study ID #: STUDY00000154
• Secondary ID: R01DK129479
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: June 2024
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.

Description:

In this study, we will recruit 180 adolescents and young adults (ages 14-25) with type 1 diabetes for at least 1 year and suboptimal diabetes control (A1c 7-13%) to participate in a 2-year randomized clinical trial aimed at reducing diabetes distress and improving glycemic outcomes. Adolescents and young adults with type 1 diabetes represent a population that often has uncontrolled diabetes with elevated A1c levels and experiences diabetes distress, making such patients ideal for this study. Participants will be randomly assigned to one of two groups (control or intervention). The intervention group will participate in monthly intervention sessions with a research assistant during the first year of the study. Four sessions will focus on improving glycemic outcomes and 8 sessions will focus on reducing diabetes distress. The sessions will be conducted face-to-face or remotely. To ensure adequate recruitment and retention, the control group will participate in the intervention sessions during the second year of the study. Participants in both groups will use continuous glucose monitoring (CGM), with CGM data downloaded every 3 months. Participants in both groups will complete surveys and have A1c measured every 6 months. We will compare the two groups on percent time in target glucose range (70-180 mg/dL), A1c, and diabetes distress from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent time in range, A1c, and diabetes distress, compared with the control group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 191
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

Inclusion Criteria:

• Age 14-25 years

• Diagnosis of type 1 diabetes (according to ADA criteria)

• Type 1 diabetes duration =12 months

• A1c 7-13%

• Smartphone or regular access to wifi via computer

• Fluency in English at a 5th grade level or higher (based on investigator assessment of grade level in school or highest grade level achieved and presence in mainstream academic classes)

Exclusion Criteria:

• Physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism)

• Participation in another intervention study within the last 3 months

• Currently pregnant or intending to become pregnant during the study (assessed by self-report)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Psychoeducation to reduce diabetes distress and improve glycemic outcomes
The intervention includes two types of sessions - those targeting an improvement in glycemic outcomes and those targeting a reduction in diabetes distress. Evidence indicates that psychoeducation and support are needed to improve self-care behaviors and optimize use of advanced diabetes technologies, which, in turn, can help improve diabetes control while also reducing diabetes distress. Participants will receive 4 one-on-one glycemic sessions and 8 one-on-one distress sessions, each lasting ~30 minutes. Sessions will be conducted in-person or remotely. The virtual sessions are intended to provide the extra psychoeducation and support needed for this high risk group without increasing the burden associated with frequent face-to-face sessions.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Stanford University	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Joslin Diabetes Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypoglycemia experience	Fear of hypoglycemia and confidence in hypoglycemia management will be assessed every 6 months with the Fear of Hypoglycemia Screener and the Hypoglycemia Confidence Scale. Change in hypoglycemia experience from 0 to 12 months will be compared within and between the intervention group and control group.	0, 6, 12, 18, and 24 months
Other	Health-related quality of life	Health-related quality of life will be assessed every 6 months with the PROMIS Global Health Measure. Change in quality of life from 0 to 12 months will be compared within and between the intervention group and control group.	0, 6, 12, 18, and 24 months
Other	Diabetes incorporation/identity	Diabetes incorporation/identity will be assessed every 6 months with the Accepting Diabetes And Personal Treatment (ADAPT) survey. Change in diabetes incorporation/identity from 0 to 12 months will be compared within and between the intervention group and control group.	0, 6, 12, 18, and 24 months
Primary	Time in Range (TIR)	CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group.	0, 3, 6, 9, 12, 15, 18, 21, and 24 months
Secondary	A1c	A1c will be assessed every 6 months. Blood samples will be collected locally using uniform procedures and sent to the central laboratory at the University of Minnesota for analysis. Change in A1c from 0 to 12 months will be compared within and between the intervention group and control group.	0, 6, 12, 18, and 24 months
Secondary	Diabetes distress	Diabetes distress will be assessed every 6 months using the validated Problem Areas in Diabetes - Pediatric survey (PAID-Peds) and the Diabetes Distress Scale. Change in diabetes distress from 0 to 12 months will be compared within and between the intervention group and control group.	0, 6, 12, 18, and 24 months
Secondary	Attitudes toward diabetes device use	Attitudes toward diabetes device use will be assessed every 6 months using the validated Glucose Monitoring Satisfaction Survey and the Diabetes Technology Attitudes Scale. Change in attitudes toward device use from 0 to 12 months will be compared within and between the intervention group and control group.	0, 6, 12, 18, and 24 months