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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

Study 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.Check my eligibility

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.See study design

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

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

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I have been diagnosed with type 1 diabetes.

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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time in Range (TIR)

Secondary outcome measures

A1c

Attitudes toward diabetes device use

Diabetes distress

Other outcome measures

Diabetes incorporation/identity

Health-related quality of life

Hypoglycemia experience

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

Find a Location

Who is running the clinical trial?

Joslin Diabetes CenterLead Sponsor

96 Previous Clinical Trials

26,383 Total Patients Enrolled

Stanford UniversityOTHER

2,386 Previous Clinical Trials

17,333,818 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,356 Previous Clinical Trials

4,314,876 Total Patients Enrolled

Media Library

Psychoeducation (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05413239 — N/A

Type 1 Diabetes Research Study Groups: Intervention Group, Control Group

Type 1 Diabetes Clinical Trial 2023: Psychoeducation Highlights & Side Effects. Trial Name: NCT05413239 — N/A

Psychoeducation (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05413239 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research experiment provide opportunities for participants of any age?

"Patients aged 14 to 25 are eligible for this medical trial. Notably, there are 218 trials targeting participants younger than 18 and 925 studies available to people 65 years old or older."

Answered by AI

Am I able to join in this experiment?

"This medical trial is inviting 180 youthful individuals aged 14-25, diagnosed with type 1 diabetes (according to ADA criteria) and an A1c range of 7-13%, who have been living with the disease for 12 or more months. Furthermore, participants must be English proficient at a 5th grade level or higher and own either a smartphone connected to Wi-Fi or access to one via computer."

Answered by AI

To what extent are individuals being included in the clinical trial?

"Affirmative. According to information on clinicaltrials.gov, this research project that was originally posted on July 26th 2022 is presently searching for participants. 180 people are needed between two distinct sites."

Answered by AI

Is the enrollment period for this clinical trial still open?

"Affirmative, information on clinicaltrials.gov implies that recruitment for this medical experiment is still open; the trial was posted at the end of July 2022 and most recently updated a day later. This study requires 180 participants to be sourced from two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05413239.