Trial | NCT01828970  Report issue

Title

Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    38
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 Started
Jan 31
2010
Primary Completion
Sep 30
2012
Study Completion
Sep 30
2012
Last Update
Apr 11
2013
Estimate

Drug Basal-bolus detemir-aspart insulin regimen

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.

  • Other names: Levemir, Novorapid

Basal-bolus specific insulin regimen Experimental

Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients

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
No Results Posted