FIRST1D
Research type
Research Study
Full title
A Study of Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion (CSII) in Adults with Type 1 Diabetes
IRAS ID
237129
Contact name
Nick Oliver
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
This study aims to contribute to the evidence base for the optimal initial insulin profile for adults with type 1 diabetes commencing continuous subcutaneous insulin infusion (CSII), also known as insulin pump therapy. CSII delivers rapid acting insulin continuously from a small, portable, battery-operated pump about the size of a small pager. It has been shown to better mimic the natural physiology of the pancreas than injections, as background insulin (basal) rates can be adjusted to meet the match the requirements of the individual. On initiation of insulin pump therapy, the basal insulin may be given as a flat rate, or as a variable rate based on circadian profiling, and adjustments to these rates are made based on blood glucose results in the next weeks and months. Using a randomised controlled trial study design, we will test the hypothesis that circadian insulin infusion rates in CSII naïve people with type 1 diabetes are closer to optimal basal rates, compared with a flat initial rate. Participants will have 7 days of blinded continuous glucose monitoring prior to the study, and continuously after initiation of CSII. At insulin pump initiation they will be randomised to a flat basal rate or circadian rate (defined by Roche Accu-Chek software) and insulin pump therapy will be initiated with standard structured education and support. Participants will do basal rate testing commencing on day 7, 14 and 28 after randomisation, which involved skipping a meal and taking capillary blood glucose tests every two hours. Participants will be reviewed at the end of each set of basal rate tests, and their basal rates adjusted based on a pre-defined criteria. The primary outcome is the absolute change in insulin basal rate over 24 hours after 3 rounds of basal rate testing.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/0196
Date of REC Opinion
16 Feb 2018
REC opinion
Favourable Opinion