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

NCT05413239 | Completed Results DMC

• 2 other identifiers: STUDY00000154R01DK129479
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 (months 0-12 reported for primary outcome analysis)

Secondary Outcomes (3)

• A1c

  0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)

• Diabetes Distress

  0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)

• Attitudes Toward Diabetes Device Use

  0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Psychoeducation to reduce diabetes distress and improve glycemic outcomes

Control Group

NO INTERVENTION

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

Interventions

Psychoeducation to reduce diabetes distress and improve glycemic outcomes BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Stanford University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Stanford University

Palo Alto, California, 94305, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Lori Laffel, MD, MPH
• Organization: Joslin Diabetes Center

lori.laffel@joslin.harvard.edu

6177322603

Study Officials

• Lori M Laffel, MD, MPH

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

• Korey K Hood, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: July 26, 2022
• Primary Completion: November 30, 2024
• Study Completion: February 1, 2026
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: After all of the investigators' analyses, presentations, and publications of study findings are complete
• Access Criteria: If it is determined that data can be shared, data will be made available upon request to qualified persons only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are complete.

Locations

US (2)