Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Basal-bolus detemir-aspart insulin regimen

• Registration Number: NCT01828970
• Lead Sponsor: Centre Europeen d'Etude du Diabete

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-11
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Basal-bolus specific insulin regimen	Basal-bolus detemir-aspart insulin regimen	Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients

Primary Outcome Measures

Name	Time	Method
Mean plasma glucose level measured 3 times just before the first hemodialysis session	Baseline and at 3 months of treatment	Determination by the glucose dehydrogenase method

Secondary Outcome Measures

Name	Time	Method
HbA1c	Baseline and at 3 months of treatment	Measured by high-performance liquid chromatography
Body weight	Baseline and at 1 month and 3 months of treatment
Insulin requirements	Baseline and at 1 month and 3 months of treatment	IU per day
Symptomatic hypoglycemia	Baseline and at 1 month and 3 months of treatment	Number of glycemia \< 60 mg/dl per patient and per month
Continuous glucose monitoring parameters	Baseline and at 1 month and 3 months of treatment	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
Deaths and major cardiovascular events	Baseline and at 3 months of treatment	All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease

Trial Locations

Locations (5)

Regional Hospital of Valenciennes; 🇫🇷 Valenciennes, France

Regional Hospital of Mulhouse; 🇫🇷 Mulhouse, France

Sainte Anne Hospital; 🇫🇷 Strasbourg, France

Regional Hospital of Colmar; 🇫🇷 Colmar, France

University Hospital of Strasbourg; 🇫🇷 Strasbourg, France