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

Roche

Status: Completed

Conditions: Diabetes Mellitus Type 1

Treatments: Device: Insulin pumps

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468754

RD000000275

RD000275

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A

Experimental group

Treatment:

Device: Insulin pumps

B

Experimental group

Treatment:

Device: Insulin pumps