Status:
COMPLETED
Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients
Lead Sponsor:
Centre Europeen d'Etude du Diabete
Collaborating Sponsors:
Novo Nordisk A/S
Abbott
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-83 years
Phase:
PHASE4
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 ...
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 fea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01828970
Start Date
January 1 2010
End Date
September 1 2012
Last Update
April 11 2013
Active Locations (5)
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1
Regional Hospital of Colmar
Colmar, France, 68000
2
Regional Hospital of Mulhouse
Mulhouse, France, 68100
3
Sainte Anne Hospital
Strasbourg, France, 67000
4
University Hospital of Strasbourg
Strasbourg, France, 67000