C-peptide status in HypoCOMPaSS
Research type
Research Study
Full title
Does C-peptide microsecretor status in individuals with long standing type 1 diabetes and impaired awareness of hypoglycaemia predict response to behavioural intervention and optimised insulin delivery/glucose monitoring in the HypoCOMPaSS study?
IRAS ID
212690
Contact name
James Shaw
Contact email
Sponsor organisation
Newcastle Upon Tyne Hospitals NHS Foundation trust
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
Severe hypoglycaemia and impaired awareness of hypoglycaemia remain greatly feared complications of diabetes and its treatment(1). The HypoCOMPaSS trial showed awareness of hypoglycaemia can be improved and severe hypoglycaemia events prevented in individuals with long standing type 1 diabetes and impaired awareness of hypoglycaemia through the delivery of a single structured education session and optimised medical management. Continued benefit was noted to extend to 2 years follow-up with a 20-fold reduction in severe hypoglycaemia events in the context of improved glycaemic control. However, of the 92% of participants affected with severe hypoglycaemia in the year pre-trial, 36% participants experienced at least one episode of severe hypoglycaemia during the follow-up period.
This study will assess residual beta-cell function in participants of the original study by a single-visit mixed meal tolerance test to explore whether C-peptide microsecretor status is a predictor of response or incomplete response to intervention in the HypoCOMPaSS trial. Participants of the multi-centre HypoCOMPaSS study will be contacted by the HypoCOMPaSS team at their original study centre, informed of the study and offered a Participant Information Sheet. A subsequent telephone call from study co-ordinators will confirm interest and participants will attend the research facility fasting on a pre-arranged date prior to completion of Informed Consent Sheet and a 2 hour mixed meal tolerance test. The Participant Information Sheet is detailed as to instruction for meal tolerance test preparation. The study will last one morning and the duration of study for each participant is one day.
1. Frier BM. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab Res Rev. 2008;24(2):87-92.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0474
Date of REC Opinion
25 Nov 2016
REC opinion
Favourable Opinion