Trial information
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine.
Status: Completed
Protocol number: RD000000275
Sponsor: Disetronic Medical Systems AG
Company division: Diagnostic
Official Scientific Title: Comparison between CSII with multiple basal Lispro infusion rates and MDI with Lispro and Glargine.
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.
Study type: Interventional; Randomized; Open Label; Active; Crossover; Efficacy study
Condition: Diabetes Mellitus, Type 1
Intervention type: Device
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 60 Years
Accepts healthy volunteers: No
Anticipated start date: July, 2003
Trial registration date: 04/23/2007
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bergamo
- Brescia
- Padova
- Pisa
