Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Basal-bolus detemir-aspart insulin regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basal-bolus specific insulin regimen<br>Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients | Drug: Basal-bolus detemir-aspart insulin regimen<br>* 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.<br>* Other names: Novorapid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean plasma glucose level measured 3 times just before the first hemodialysis session | Determination by the glucose dehydrogenase method | Baseline and at 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Measured by high-performance liquid chromatography | Baseline and at 3 months of treatment | 
| Body weight |  | Baseline and at 1 month and 3 months of treatment | 
| Insulin requirements | IU per day | Baseline and at 1 month and 3 months of treatment | 
| Symptomatic hypoglycemia | Number of glycemia < 60 mg/dl per patient and per month | 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 | 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 | Baseline and at 3 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Hemodialysis, Continuous glucose monitoring, Insulin analogues