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Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

NCT01828970 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2013-04-11

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Centre Europeen d'Etude du Diabete

    lead OTHER

Principal Investigators

  • Laurence Kessler, PhD · University Hospital of Strasbourg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828970 on ClinicalTrials.gov