Remission Evaluation of Metabolic Interventions in Type 2 Diabetes in Primary Care (REMIT-Prime): An Implementation-effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 118
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Type 2 diabetes (T2D) is a major health problem in Canada, affecting 11 million Canadians. Individuals with diabetes have a greater risk of developing blindness or being hospitalized with cardiovascular disease, end-stage renal disease, and lower limb amputations compared to the general population. Currently, T2D management involves lifestyle modification and glucose-lowering medications in response to rising glucose levels and failing therapeutic regimens. This approach leads to frequent self-blood glucose monitoring (SBGM), clinical appointments, and chronic polypharmacy, all of which are associated with increased risk of adverse effects, non-adherence to medications, and poor quality of life.
Evidence that T2D can be completely or partially reversed is now challenging the traditional approach to its management. Strategies combining dietary interventions, intensive metabolic and pharmacotherapy strategies, or bariatric surgery have been shown to induce diabetes remission. However, extremely low-calorie diets or bariatric surgery is not acceptable to many patients and not scalable for primary care, where diabetes care is primarily delivered.
Over the past 7 years, our investigators of Canadian multidisciplinary health care providers, patient partners, physicians, and researchers have identified and tested non-surgical remission-inducing therapeutic regimens in people with T2D. The Remission Evaluation of Medical Interventions in T2D (REMIT) program comprises 1 pilot study, 3 completed pan-Canadian multicentre (8 sites) trials, and one ongoing trial. For all the trials, the paradigm tested was one of a 3 to 4-month remission-induction period, followed by a 1-year follow-up period to detect relapse. All 5 trials tested the efficacy of an induction period during which normoglycemia was targeted to reduce glucotoxicity with frequent health coaching (focused on self-efficacy, weight reduction, and physical activity), metformin and basal insulin. These trials also included additional metabolic therapy with either: a) dapagliflozin (SGLT2 inhibitor); b) sitagliptin (DPP-4 inhibitor); c) lixisenatide (GLP-1 receptor agonist); or d) liraglutide. In all 5 trials, glucose-lowering drugs were stopped after 3-4 months. Participants with a glycated hemoglobin (A1C) <7.3% were classified as being in possible remission and followed for relapse. Following the pilot study, all 3 completed trials observed a lower hazard of relapse in the intervention group with hazard ratios of 0.60 (95% CI 0.39, 0.95) for the sitagliptin trial, 0.57 (95% CI 0.39, 0.81) for the dapagliflozin trial 0.57 (95% CI 0.40, 0.81) for the lixisenatide trial.
The findings from the previous trials suggest that a short-term intensive intervention with passive follow-up is a viable alternative to achieving remission. Research is needed to test the implementation of an intensive short-term remission approach in real-world settings such as primary care. Therefore, the REMIT-Prime study will use an implementation-effectiveness evaluation approach to assess the REMIT short-term metabolic intervention on the real-world effectiveness and understand implementation barriers and facilitators in primary care settings. This proposed study seeks to simultaneously test the clinical effectiveness and an implementation strategy in one partnering site (Escarpment Health Centre, in Hamilton, Ontario [EHC]), to inform additional implementation sites. Ultimately, the program of REMIT-Prime will inform the future scale, spread and sustainability of the REMIT intervention in primary care.
1.2 What are the principal questions to be addressed?
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.