← Back to Search

Behavioral Intervention

Psychoeducation for Type 1 Diabetes

N/A

Waitlist Available

Led By Lori M Laffel, MD, MPH

Research Sponsored by Joslin Diabetes Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 1 diabetes duration ≥12 months

Diagnosis of type 1 diabetes (according to ADA criteria)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 3, 6, 9, 12, 15, 18, 21, and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a behavioral intervention to help reduce stress and improve blood sugar control in 14-25 year olds with Type 1 diabetes, in order to improve their short and long term health.

Who is the study for?

The HAPPY T1D trial is for young people aged 14-25 with Type 1 Diabetes, who have an A1c level between 7-13%, and can use a smartphone or computer with wifi. They must speak English well enough to understand the material (5th grade level) and have had diabetes for at least a year. It's not for those pregnant or planning pregnancy, in another study recently, or with conditions like autism that could limit participation.

What is being tested?

This trial tests a behavioral/psychoeducational program designed to help reduce stress related to diabetes (diabetes distress) and improve blood sugar control in adolescents and young adults with Type 1 Diabetes over two years.

What are the potential side effects?

Since this is a psychoeducational intervention focusing on behavior and education rather than medication, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had Type 1 diabetes for at least a year.

Select...

I have been diagnosed with type 1 diabetes.

Select...

I am between 14 and 25 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 3, 6, 9, 12, 15, 18, 21, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 3, 6, 9, 12, 15, 18, 21, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3, 6, 9, 12, 15, 18, 21, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time in Range (TIR)

Secondary study objectives

A1c

Attitudes toward diabetes device use

Diabetes distress

Other study objectives

Diabetes incorporation/identity

Health-related quality of life

Hypoglycemia experience

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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

Group II: Control GroupActive Control1 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).

0 / 3Eligibility criteria met