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
Overview
- Phase
- Phase 4
- Intervention
- Basal-bolus detemir-aspart insulin regimen
- Conditions
- Diabetes Mellitus
- Sponsor
- Centre Europeen d'Etude du Diabete
- Enrollment
- 38
- Locations
- 5
- Primary Endpoint
- Mean plasma glucose level measured 3 times just before the first hemodialysis session
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age between 18 and 83 years
- •diagnosis of type 1 or type 2 diabetes
- •treatment with insulin injections or oral hypoglycemic agents
- •HbA1c ≥ 7% (i.e., 53 mmol/mol)
- •on hemodialysis for more than three months
Exclusion Criteria
- •unstable anemia or blood transfusions within the two months prior to the beginning of the study
- •a life expectancy of less than 1 year
- •chronic inflammatory disease
- •evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
- •noncompliant patients
Arms & Interventions
Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients
Intervention: Basal-bolus detemir-aspart insulin regimen
Outcomes
Primary Outcomes
Mean plasma glucose level measured 3 times just before the first hemodialysis session
Time Frame: Baseline and at 3 months of treatment
Determination by the glucose dehydrogenase method
Secondary Outcomes
- HbA1c(Baseline and at 3 months of treatment)
- Body weight(Baseline and at 1 month and 3 months of treatment)
- Insulin requirements(Baseline and at 1 month and 3 months of treatment)
- Symptomatic hypoglycemia(Baseline and at 1 month and 3 months of treatment)
- Continuous glucose monitoring parameters(Baseline and at 1 month and 3 months of treatment)
- Deaths and major cardiovascular events(Baseline and at 3 months of treatment)