Diabetes Mellitus Clinical Trial
Official title:
Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study
The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes
We conducted a pilot prospective multicenter study in five French centers (Strasbourg
University Hospital, Strasbourg Sainte Anne Hospital, Colmar, Mulhouse, Valenciennes)
designed to evaluate the feasibility and effects of a 3 month treatment regimen with
rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir,
respectively) along with CGM on glucose level control in diabetic hemodialyzed patients.
All patients who were admitted to the nephrology departments and matched the inclusion
criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the
study. CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of
treatment. It was started during the first dialysis session and then continued for the next
two days at home under ambulatory conditions. The CGM was continued during the next dialysis
session. Therefore, in total, CGM (Navigator®; Abbott, Rungis, France) was performed for 54
hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of
treatment. The probe for the system was subcutaneously inserted at the beginning of the
first dialysis session to analyze interstitial glucose, and it was removed at the end of the
second dialysis session. Due to the time required for CGM calibration, plasma glucose levels
were only partially recorded during the first dialysis session.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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