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

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ClinicalTrials.gov Identifier: NCT01828970
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Collaborators:
Novo Nordisk A/S
Abbott
Information provided by (Responsible Party):
Centre Europeen d'Etude du Diabete

Study Description
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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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Basal-bolus detemir-aspart insulin regimen Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. HbA1c [ Time Frame: Baseline and at 3 months of treatment ]
    Measured by high-performance liquid chromatography

  2. Body weight [ Time Frame: Baseline and at 1 month and 3 months of treatment ]
  3. Insulin requirements [ Time Frame: Baseline and at 1 month and 3 months of treatment ]
    IU per day

  4. 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

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 83 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828970


Locations
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France
Regional Hospital of Colmar
Colmar, France, 68000
Regional Hospital of Mulhouse
Mulhouse, France, 68100
Sainte Anne Hospital
Strasbourg, France, 67000
University Hospital of Strasbourg
Strasbourg, France, 67000
Regional Hospital of Valenciennes
Valenciennes, France, 59300
Sponsors and Collaborators
Centre Europeen d'Etude du Diabete
Novo Nordisk A/S
Abbott
Investigators
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Study Director: Laurence Kessler, PhD University Hospital of Strasbourg
More Information
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Publications of Results:

Other Publications:
U S Renal Data System, USRDS 2012 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012. Available from http://www.usrds.org/atlas.aspx

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Responsible Party: Centre Europeen d'Etude du Diabete
ClinicalTrials.gov Identifier: NCT01828970    
Other Study ID Numbers: 09/43
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Keywords provided by Centre Europeen d'Etude du Diabete:
Diabetes Mellitus
Hemodialysis
Continuous glucose monitoring
Insulin analogues
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs