Research Article: Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1): protocol for a randomised feasibility trial of an intermittent and continuous low-energy diet in patients with type 1 diabetes and overweight and obesity
Abstract:
Introduction Rising levels of overweight and obesity among people with type 1 diabetes (T1D) contribute to insulin resistance, dyslipidaemia, retinopathy, cardiometabolic complications and psychological morbidity. Continuous low-energy diets (CLED) providing approximately 800 kcal (3347?kJ)/day can produce significant weight loss in type 2 diabetes, and intermittent low-energy diets (ILED) may be an alternative. The Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1) aims to assess the safety, acceptability and feasibility of remotely delivered ILED and CLED programmes for people with T1D and overweight and obesity. Methods and analysis Twelve participants with T1D and body mass index ?27.5?kg/m 2 (?25?kg/m 2 in high-risk ethnic minorities) recruited from an National Health Service (NHS) trust and research register in England will be randomised to a remotely delivered CLED (n=6) or ILED (n=6) for 12 weeks. The CLED includes a daily Optifast 850 kcal (3556?kJ) 75?g carbohydrate formula diet. The ILED includes 2?days/week of Optifast and 5?days of a portion-controlled Mediterranean diet (170–250?g carbohydrate/day). Both groups will receive matched high-frequency remote support from a dietitian, nurse and psychologist via telephone and/or the Oviva app. The primary outcome will assess safety (occurrence of severe hypoglycaemia, ketonaemia, ketoacidosis and time above and below target blood glucose). Secondary outcomes include study uptake, retention, dietary adherence, acceptability, intervention delivery fidelity and potential efficacy in relation to change in weight, insulin requirements, glycated haemoglobin, lipids, insulin resistance (estimated glucose disposal rate) and quality of life. Participants will be invited for optional repeat measurements at 52 weeks. Ethics and dissemination The trial protocol (V4.0/08.06.2022) was granted ethical approval by Cambridge East Research Ethics Committee (Ref: 21/EE/0014). The study will inform progression to a full-scale randomised controlled trial to test the efficacy of these programmes for patients with T1D and overweight and obesity. Trial registration number NCT04674384 ; Pre-results.
Introduction:
Background There are approximately 400?000 people with type 1 diabetes (T1D) in the United Kingdom, with rates increasing by 4% annually. 1 T1D is associated with a healthy bodyweight; however, overweight and obesity is becoming increasingly common in this population due, in part, to modern more intensive approaches to manage hyperglycaemia with higher daily doses of insulin, as evidenced by the Diabetes Control and Complications Trial, and other studies. 2 3 The prevalence of obesity (body mass index (BMI)…
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