What side effects are associated with this type of intervention?

The most common treatment for Type 1 Diabetes is insulin therapy, which can cause side effects such as hypoglycemia (low blood sugar), weight gain, and injection site reactions (redness, swelling, or pain). Other treatments that may be used in combination with insulin, such as metformin or GLP-1 agonists like liraglutide, can also cause gastrointestinal symptoms like nausea and vomiting. It is important for patients to work closely with their healthcare providers to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes (T1D), primarily focusing on insulin therapy, which remains the cornerstone of T1D management. While the Parent Group Education Sessions trial emphasizes improved parental support and education, it does not directly align with specific drug approvals. However, the trial's approach complements the use of insulin by potentially enhancing adherence and self-management through better parental involvement. No specific FDA-approved drugs for T1D directly focus on educational interventions, but the comprehensive management of T1D includes both pharmacological treatments and supportive educational strategies.

What other types of research exist?

Promising alternatives to Parent Group Education Sessions for Type 1 Diabetes patients include: 1) Smartphone technology-based interventions, which have shown interest and potential in managing diabetes among ethnic minority adolescents and their parents. 2) Decision coaching using tools like the Ottawa Family Decision Guide, which has been field-tested with positive outcomes. 3) Online education and support interventions, which have been evaluated and shown to provide significant support for adolescents with diabetes. These alternatives leverage technology and personalized coaching to enhance diabetes management and support.

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Parent Group Education for Adolescent Type 1 Diabetes Transition (GETIT-Parent Trial)

N/A

Waitlist Available

Led By Meranda Nakhla, MD

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

Participants must be fluent in English or French

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 6, 12, 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if group education for parents of teens with type 1 diabetes helps improve the transition to adulthood. The study focuses on parents and aims to teach them how to better support their children in managing their diabetes. The goal is to see if these sessions can make a positive difference in the teens' health and self-management.

Who is the study for?

This trial is for parents fluent in English or French, of adolescents aged 14-16 with type 1 diabetes (T1D), who are patients at Montreal Children's Hospital. It excludes those already in the GET-IT-T1D adolescent trial or with severe neurocognitive disabilities.

What is being tested?

The study tests if group education sessions for parents can help their teens transition into adulthood better than usual diabetes care alone. This pilot randomized controlled trial will lead to a larger study on self-management and health outcomes.

What are the potential side effects?

Since this trial involves educational sessions rather than medical treatments, there are no direct side effects like you'd expect from medication. However, participants may experience stress or emotional discomfort.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am fluent in either English or French.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 6, 12, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 6, 12, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 6, 12, 18 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

Adherence feasibility

Recruitment feasibility

Response feasibility

+1 more

Secondary study objectives

Diabetes Distress - Adolescent

Diabetes Distress - Parent

Diabetes Resilience - Adolescent

+9 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: Usual diabetes careExperimental 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 care, individual sessions and meetings related to transition care with the diabetes social worker will be provided to parents, as needed.

Group II: Group education sessions for parents plus usual diabetes careExperimental Treatment1 Intervention

≥3 in-person/virtual one-hour group education sessions for parents plus usual diabetes care, every 3 months for 12 months and ≥3 "check-in" virtual 15-20 minute sessions in-between the group sessions. Each group session (3-8 parents per group) will be facilitated by a diabetes social worker and will consist of parent-driven discussions on topics relevant to adolescence and transition care. Each one-hour session will commence with an ice-breaker activity and then move to a parent-driven, facilitator-mediated discussion. The group session content will be guided by the needs of the participants; however, the facilitator will actively promote discussion on adolescent- and transition-related topics. The group discussion will end with participants setting goals for their next session.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for Type 1 Diabetes (T1D) is insulin therapy, which involves administering exogenous insulin to replace the insulin that the pancreas can no longer produce. This is essential for maintaining normal blood glucose levels and preventing complications. Additionally, educational interventions, such as parent group education sessions, play a significant role in improving disease management. These sessions enhance parents' understanding of insulin administration, carbohydrate counting, and recognizing signs of hypo- and hyperglycemia, thereby optimizing clinical outcomes and improving the quality of life for both patients and their families.

Dietitians' perspectives on challenges and prospects for group-based education to adults with type 1 diabetes - a qualitative study.E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials.Routine hospital admission versus out-patient or home care in children at diagnosis of type 1 diabetes mellitus.