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

NCT07665567 | Enrolling By Invitation

• 1 other identifier: Veritas IRB 2025 3865-23452
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes (T2DM)

Keywords

T2D

Outcome Measures

Primary Outcomes (1)

• glycated hemoglobin HbA1C

  glycemic control

  16, 28,40, 52, 68 weeks

Secondary Outcomes (1)

• Weight

  At baseline, intensive period (16 weeks) and at the end of the study (68 weeks)

Other Outcomes (1)

• European Quality of Life- 5 Dimensions

  Baseline, 16, 28, 40, 52 and at the end of the study (68 weeks)

Study Arms (1)

Remission group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living with type 2 diabetes for at least 5 years or less, who are on (maximum) two glucose lowering medications plus basal insulin.

You may qualify if:

• Adults aged 30-80 years with:
• Type 2 diabetes diagnosed ≤ 5 years;
• stable type 2 diabetes drug regimen in the 8 weeks before consent;
• 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;
• Body Mass Index ≥ 23 kg/m2;
• ability to perform self-blood glucose monitoring or wear a continuous blood glucose monitor;
• access to a telephone; and
• ability to read, write, and provide informed consent in English.

You may not qualify 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Escarpment Health Centre

Hamilton, Ontario, L9C 7N4, Canada

Location

Related Publications (1)

• Sherifali DT, Racey ME, Greenway MK, Alliston PE, Ali MU, Gerstein HC; Integrated Knowledge Translation (iKT) Type 2 Diabetes Remission Advisory Team*. Type 2 Diabetes Remission: A Systematic Review and Meta-analysis of Nonsurgical Randomized Controlled Trials. Diabetes Care. 2025 Dec 1;48(12):2181-2191. doi: 10.2337/dc25-0562.

  PMID: 40982327 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Diana Sherifali, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-01

Locations

CA (1)