Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients (GlyCEDIA)

April 9, 2013 updated by: Centre Europeen d'Etude du Diabete

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

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

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Colmar, France, 68000
        • Regional Hospital of Colmar
      • Mulhouse, France, 68100
        • Regional Hospital of Mulhouse
      • Strasbourg, France, 67000
        • University Hospital of Strasbourg
      • Strasbourg, France, 67000
        • Sainte Anne Hospital
      • Valenciennes, France, 59300
        • Regional Hospital of Valenciennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and at 3 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline and at 3 months of treatment
Measured by high-performance liquid chromatography
Baseline and at 3 months of treatment
Body weight
Time Frame: Baseline and at 1 month and 3 months of treatment
Baseline and at 1 month and 3 months of treatment
Insulin requirements
Time Frame: Baseline and at 1 month and 3 months of treatment
IU per day
Baseline and at 1 month and 3 months of treatment
Symptomatic hypoglycemia
Time Frame: Baseline and at 1 month and 3 months of treatment
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
Time Frame: 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
Baseline and at 1 month and 3 months of treatment
Deaths and major cardiovascular events
Time Frame: Baseline and at 3 months of treatment
All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease
Baseline and at 3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Laurence Kessler, PhD, University Hospital of Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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