MIDDAS-Type 1
Research type
Research Study
Full title
Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1) - A Randomised Feasibility Trial of an Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) in Patients with Type 1 Diabetes and obesity
IRAS ID
289901
Contact name
Basil Issa
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Research summary
This study will test the safety and acceptability of two different low calorie diets that are aimed at helping people with Type 1 diabetes lose weight and improve their blood sugar control. Twelve patients will be randomly allocated to one of the two low calorie diets. The daily low calorie diet involves 850 calorie days every day for 12 weeks. The intermittent low calorie diet involves two consecutive 850 calorie days plus five days of a healthy Mediterranean diet each week for 12 weeks. The low calorie days will involve Nestle Optifast® meal replacements (shakes/soups). Meal replacements are one way to achieve an accurate calorie and carbohydrate controlled diet while delivering all the nutrients we need. \n\nThere will be support from a team of health professionals including a dietitian, nurse, psychologist and doctor. The team will support participants by telephone and/or the Oviva® smartphone app which facilitates messaging, photos, video calls and logging of weight and blood pressure. The Freestyle Libre is a blood sugar monitoring device that will allow the healthcare team to view the participants’ blood sugar remotely for safety. \n\nThe findings of this study will inform a larger study looking at how feasible it is to deliver low calorie diet programmes with remote support from healthcare professionals to people with Type 1 diabetes to help them lose weight and improve their blood sugar control. This has the potential to reduce their risk of diabetes complications and other physical and mental health problems associated with Type 1 diabetes.Lay summary of study results
The study showed that it was feasible to use continuous and intermittent low energy diets for managing overweight and obesity in individuals with Type 1 diabetes. A manuscript is being prepared to be submitted for publication.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0014
Date of REC Opinion
18 Mar 2021
REC opinion
Further Information Favourable Opinion