Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients
NCT ID: NCT01828970
Last Updated: 2013-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2010-01-31
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* a life expectancy of less than 1 year
* chronic inflammatory disease
* evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
* noncompliant patients
18 Years
83 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Abbott
INDUSTRY
Centre Europeen d'Etude du Diabete
OTHER
Responsible Party
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Principal Investigators
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Laurence Kessler, PhD
Role: STUDY_DIRECTOR
University Hospital of Strasbourg
Locations
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Regional Hospital of Colmar
Colmar, , France
Regional Hospital of Mulhouse
Mulhouse, , France
Sainte Anne Hospital
Strasbourg, , France
University Hospital of Strasbourg
Strasbourg, , France
Regional Hospital of Valenciennes
Valenciennes, , France
Countries
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References
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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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Other Identifiers
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09/43
Identifier Type: -
Identifier Source: org_study_id
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