AIDgastro
Research type
Research Study
Full title
Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
IRAS ID
313818
Contact name
Nick Oliver
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Gastroparesis affects around 4-5% of people living with both type 1 diabetes, meaning that in the United Kingdom up to 20,000 live with both conditions. People with gastroparesis are less likely to use continuous glucose monitoring or insulin pump therapy, and are at greater risk of severe hypoglycaemia requiring the assistance of a third party for active treatment. People with type 1 diabetes and gastroparesis are therefore a particularly high risk group, may not be identified in clinic services and may not be offered support and solutions.
This randomised control pilot study aims to clinically evaluate the Medtronic 780G system, an automated insulin delivery (AID) system, in 16 people with type 1 diabetes and gastroparesis compared to their standard care. An AID system is comprised of an insulin pump, a continuous glucose monitor and a control algorithm that adjusts insulin delivery in response to real-time glucose changes. Recruitment will be undertaken from the type 1 diabetes and gastroenterology clinics at Imperial College Healthcare NHS Trust.
The total duration for each participant will be 14 weeks. Following a run-in period of 2 weeks using real-time continuous glucose monitoring, participants will be randomised to control (standard care and real-time CGM) or AID and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or control and finally 4-week AID). There are 5 study visits and two telephone visits in total.
The primary outcome is percentage time spent in glucose target (3.9-10mmol/L) and secondary outcomes include percentage time spent in hypoglycaemia (low glucose and hyperglycaemia (high glucose, gastrointestinal symptom scores and patient-reported measures.
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0028
Date of REC Opinion
16 Mar 2023
REC opinion
Further Information Favourable Opinion