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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
After the first CGM was completed during the conventional anti-diabetic treatment, patients received a rapid-acting insulin analogue before each meal (i.e., aspart) and a basal long-acting insulin analogue (i.e., detemir) once or twice daily. The analogues were titrated for optimal glycemic control. After one month of the aspart and detemir regimen, a physician adapted the insulin doses according to the glucose values observed from the second CGM.
Regional Hospital of Colmar
Colmar, France
Regional Hospital of Mulhouse
Mulhouse, France
Sainte Anne Hospital
Strasbourg, France
University Hospital of Strasbourg
Strasbourg, France
Mean plasma glucose level measured 3 times just before the first hemodialysis session
Determination by the glucose dehydrogenase method
Time frame: Baseline and at 3 months of treatment
HbA1c
Measured by high-performance liquid chromatography
Time frame: Baseline and at 3 months of treatment
Body weight
Time frame: Baseline and at 1 month and 3 months of treatment
Insulin requirements
IU per day
Time frame: Baseline and at 1 month and 3 months of treatment
Symptomatic hypoglycemia
Number of glycemia \< 60 mg/dl per patient and per month
Time frame: Baseline and at 1 month and 3 months of treatment
Continuous glucose monitoring parameters
Including: mean continuous glucose monitoring glucose values, within-subjects standard deviation (wSD) and coefficient of variation (wCV = wSD/mean), mean amplitude of glycemic excursion (MAGE), frequency of glucose values under 60 mg/dl, and frequency of glucose values higher than 180 mg/dl
Time frame: Baseline and at 1 month and 3 months of treatment
Deaths and major cardiovascular events
All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease
Time frame: Baseline and at 3 months of treatment
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Regional Hospital of Valenciennes
Valenciennes, France