Overview

Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Europeen d'Etude du Diabete
Collaborators:
Abbott
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Long-Acting
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