A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 1
• Interventions: Device: Insulin pumps

• Registration Number: NCT00468754
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2007-05-02
• Study First Submitted QC: 2007-05-02
• Study First Posted: 2007-05-03
• Status Verified: 2010-06
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Type 1 diabetic patients, 18-60 years of age
• Diabetic for >2 years
• Treated with CSII for >=6 months
• HbA1c <8.5%

Exclusion Criteria

• Treatment with daily insulin injections
• Inability to handle pump therapy
• Untreated retinopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Insulin pumps	-
A	Insulin pumps	-

Primary Outcome Measures

Name	Time	Method
Variability of blood glucose characterised by the standard deviation of the mean blood glucose	Length of study

Secondary Outcome Measures

Name	Time	Method
HbA1c	Length of study
Frequency of severe hypoglycemia	Length of study
Daily insulin requirement	Length of study
Mean BG during the last month of the respective treatment period	Length of study