Clinical trial NCT05413239: Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Stanford University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-06-09
Enrollment: 191
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time in Range (TIR)
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months
Secondary outcomes:
measure: A1c
timeFrame: 0, 6, 12, 18, and 24 months
measure: Diabetes distress
timeFrame: 0, 6, 12, 18, and 24 months
measure: Attitudes toward diabetes device use
timeFrame: 0, 6, 12, 18, and 24 months
Other outcomes:
measure: Hypoglycemia experience
timeFrame: 0, 6, 12, 18, and 24 months
measure: Health-related quality of life
timeFrame: 0, 6, 12, 18, and 24 months
measure: Diabetes incorporation/identity
timeFrame: 0, 6, 12, 18, and 24 months
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Lori M Laffel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Korey K Hood, PhD
role: PRINCIPAL_INVESTIGATOR
References: