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

Joslin Diabetes Center

Status: Active, not recruiting

Conditions: Type 1 Diabetes

Treatments: Behavioral: Psychoeducation to reduce diabetes distress and improve glycemic outcomes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05413239

STUDY00000154

R01DK129479 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 191 patients

Sex: All

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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191 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The Intervention Group will receive the monthly intervention sessions during the first year of the study.

Treatment:

Behavioral: Psychoeducation to reduce diabetes distress and improve glycemic outcomes

Control Group

No Intervention group

Description:

The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).