Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Blood glucose variability is lower during Continuous Subcutaneous Insulin Infusion (CSII) as compared to Multiple Daily Insulin injection (MDI) with Glargine.
Ethics approval
Approval received from the local ethics committee (Regione del Veneto, Azienda Ospedaliera di Padova, Comitato Etico per la Sperimentazione) on the 10th February 2003 (ref: 12998).
Study design
Multicentre, randomised, cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetes mellitus type one
Intervention
Patients were randomly assigned to Continuous Subcutaneous Insulin Infusion (CSII) with lispro or Multiple Daily Injections (MDI) with lispro and glargine. After four months they were switched to the alternative treatment.
Intervention type
Drug
Phase
Not Specified
Drug names
Lispro, glargine
Primary outcome measures
Blood glucose variability as measure by standard deviation of mean blood glucose.
Data of the last month of each treatment period were analysed.
Secondary outcome measures
1. HbA1c
2. Quality of metablic control characterised by the mean Blood Glucose (BG) during the last month of the respective treatment period
3. Mean and the standard deviation of the weekly BG (altogether and at the different points in time)
4. Frequency of BG greater than 8.0 mmol/l
5. Frequency of BG less than 3.5 mmol/l with or without any symptoms of hypoglycaemia
6. Frequency of severe hypoglycaemia (BG less than 2.0 mmol/l)
7. Frequency of severe hypoglycaemia (BG less than 2.0 mmol/l) day over
8. Frequency of severe hypoglycaemia (BG less than 2.0 mmol/l) night over
9. Frequency of Diabetic Ketoacidosis (DKA)
10. Frequency of hospitalisation or the use of an ambulance due to hypoglycaemic or ketotic/ketoacidotic events
11. Number of daily BG measurements
12. Daily insulin requirement (basal/preprandial, meal and correction boluses)
13. Number of daily glargine injections
14. Body weight
15. Treatment satisfaction measured by Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Data of the last month of each treatment period were analysed.
Overall trial start date
24/07/2003
Overall trial end date
16/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type one diabetic patients (World Health Organisation [WHO] classification)
2. Between 18 and 60 years old
3. Have been diabetics for more than two years
4. Have been treated with CSII for at least six months prior to the study
5. HbA1c needs to be less than 8.5%
6. Patients should be familiar with carbohydrate counting and should be able to change insulin doses (either by pump or injections) based on changes in food intake and physical exercise
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
1. Poor motivation
2. Body Mass Index (BMI) greater than 30 kg/m^2
3. Treatment with daily insulin injections
4. Inability to handle pump therapy (pump handling, infusion set handling, compliance with treatment rules)
5. Untreated retinopathy
Recruitment start date
24/07/2003
Recruitment end date
16/05/2005
Locations
Countries of recruitment
Italy
Trial participating centre
Azienda Ospedaliera di Padova
Padova
35128
Italy
Sponsor information
Organisation
Disetronic Medical Systems AG (Switzerland)
Sponsor details
Kirchbergstrasse 190
Burgdorf
3401
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Disetronic Medical Systems AG (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary