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Group Education for Type 1 Diabetes (GET-IT-T1D Trial)

N/A

Waitlist Available

Led By Meranda Nakhla, MD, MSc

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

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

Must have

Adolescents with a diagnosis of Type 1 Diabetes

16 to 17 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0,12, 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is examining whether group education visits integrated into pediatric care, compared with usual care, has an effect on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures after the transfer to adult care for emerging adults with type 1 diabetes (T1D).

Who is the study for?

This trial is for adolescents aged 16-17 with Type 1 Diabetes, fluent in English or French, and receiving care at specific clinics in Montreal. It's not for those with severe neurocognitive disabilities or conditions like hemolytic anemia that affect blood test accuracy.

What is being tested?

The study tests if group education visits can help manage Type 1 Diabetes better than usual care alone. Participants will be randomly assigned to either the new approach or standard treatment and tracked for changes in their HbA1c levels and psychosocial outcomes over two years.

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications, there are no direct side effects from drugs. However, participants may experience stress or anxiety related to group settings or discussions about their condition.

Eligibility Criteria

Inclusion Criteria

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

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I am a teenager diagnosed with Type 1 Diabetes.

Select...

I am 16 or 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0,12, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0,12, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0,12, 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

Hemaglobin A1c (HbA1c)

Secondary study objectives

Cost effectiveness (HbA1c)

Cost effectiveness (QOL)

Cost effectiveness (self-efficacy)

+12 more

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

Group I: ControlExperimental Treatment1 Intervention

Usual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual diabetes care, an individual education session and written information will be provided before formal transfer.

Group II: ActiveExperimental Treatment1 Intervention

≥3 group education sessions (60 minutes per session) in addition to usual diabetes care, every 3 months for 12 months. Each group session (3-8 patients per group) will be facilitated by a diabetes nurse educator and/or dietitian. The group session content will be guided by the needs of the group participants. The group discussion will end with participants setting goals for their next appointment.

0 / 2Eligibility criteria met