MedicalResearch.com Interview with:
Dr Marcus Lind
Associate Professor of Diabetology at the University of Gothenburg
Gothenburg, Sweden
Chief Physician of Diabetology, Uddevalla Hospital
Uddevalla, Sweden
MedicalResearch.com: What is the background for this study?
Response: This was a randomized trial over 16 months (cross-over study with 26 weeks of each treatment and a between wash-out period of 17 weeks) of 161 persons with type 1 diabetes. The main purpose was to evaluate whether a “diabetes tool”, denoted continuous glucose monitoring improves the glycaemic control, known to be essential to lower risks for diabetic complications such as injuries on eyes, kidneys, nerves and the cardiovascular system. The study also evaluated whether the glucose could be stabalised, i.e. having less fluctutations (beside the average level per se) and whether well-being, treatment satisfaction and feeling more confident in the daily living to avoid low glucose values which lead influence the cognitive function and can lead to unconciousness. Earlier trials exist of this therapy in connection to insulin pumps. But it has not been tested in randomized trials with persons only using multiple daily insulin injections to administer insulin which is the most common therapy among adults with type 1 diabetes.
Another novelty is that the current CGM-system (DexCom G4) has earlier shown a high accuracy and positive treatment experience among persons with type 1 diabetes, but it has not been tested in long-term randomized trials. Of note this trial was performed among adults with type 1 diabetes.
Continuous glucose monitoring (CGM) is a system where the patient has a sensor subcutaneously that he/she easily can change every week. It estimates the glucose level every minute and shows values on a hand-held small monitor (size of a small cell-phone) and whether the glucose levels are rising or declining. The hypothesis with the study is that if the patient has continuous information of the glucose level and trends it will improve treatment variables. The comparison group was that patients got information of their glucose control via capillary finger sticks which has been the general treatment for a long time period but can only be made at certain occasions since a procedure where blood must be taken from the finger tips.
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