Remission Evaluation of Metabolic Interventions in Type 2 Diabetes in Primary Care (REMIT-Prime)

NCT07665567 · tracked via the Priya Life Science Canada tracker

Sponsor

McMaster University

Phase

Observational

Started

2026-03-11

Last updated

2026-06-24

Condition(s) studied

Type 2 Diabetes (T2DM)

Study summary

The Remission Evaluation of Metabolic Interventions in Type 2 diabetes (REMIT) program incorporates a non-surgical-remission-inducing therapeutic approach, pairing health coaching with physician-led pharmacotherapy. This approach has been tested in 5 multi-cite trials (1 pilot, 3 completed and 1 ongoing) and suggests an intensive short-term intervention with passive follow up supports patients in achieving remission. Further research is needed to evaluate the feasibility of the short-term REMIT intervention in real-world settings such as primary care and inform the future rollout of the program in multiple sites across Ontario.

The REMIT-Prime study will evaluate the REMIT short-term metabolic intervention in a primary care setting (Hamilton, Ontario), with the aims of investigating the feasibility and acceptability of the REMIT intervention in primary care settings and understanding the context for implementation. One hundred and eighteen eligible participants from the primary care site will be offered the REMIT intervention or waitlisted as a natural control group. The study protocols will be collaboratively designed and finalized with a primary care team and patient partners to elicit feedback on the adoption and feasibility of the intervention in primary care. Healthcare professionals from the CFFM will also be interviewed and asked to describe their experiences with the intervention. The findings from these interviews will support the rapid translation and rollout of the REMIT program in other interested primary care sites, including in London and Cambridge, Ontario.

Eligibility

Sex

ALL

Min age

30 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: Adults aged 30-80 years with: 1. Type 2 diabetes diagnosed ≤ 5 years; 2. stable type 2 diabetes drug regimen in the 8 weeks before consent; 3. glycated hemoglobin HbA1C 6.5-9.5% on no glucose-lowering drugs or 6.5-8.0% on 1-2 glucose-lowering drugs or 6.5-7.5% on basal insulin; 4. Body Mass Index ≥ 23 kg/m2; 5. ability to perform self-blood glucose monitoring or wear a continuous blood glucose monitor; 6. access to a telephone; and 7. ability to read, write, and provide informed consent in English. Exclusion Criteria: Individuals will be excluded if: a) coaching may not be appropriate (e.g., impaired cognition); b) pregnant (or planning pregnancy) at the time of recruitment; c) cohabiting with a participant in the study (to reduce contamination); d) have an underlying medical condition that may limit one's participation in the study (e.g. history of cardiovascular disease, injury, or contraindication to any study medication (e.g. metformin)); e) history of bariatric surgery, or planned bariatric surgery in the next 1.5 years; f) history of any major illness with a life expectancy of \< 3 years; g) history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity; h) excessive alcohol intake, acute or chronic; or i) inability to take the study medications. \-

Primary outcome measure(s)

glycated hemoglobin HbA1C — 16, 28,40, 52, 68 weeks
glycemic control

Trial sites (1)

Facility	City	Region	Status
Escarpment Health Centre	Hamilton	Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07665567 on ClinicalTrials.gov ↗ ← All trials in Canada