Comparison between continuous subcutaneous insulin infusion with multiple basal lispro infusion rates and multiple daily insulin injection with lispro and glargine

• Register: ISRCTN
• Last refreshed on: 4 October 2021
• Main ID: ISRCTN37153662
• Date of registration: 25/04/2007
• Prospective Registration: No
• Primary sponsor: Disetronic Medical Systems AG (Switzerland)
• Public title: Comparison between continuous subcutaneous insulin infusion with multiple basal lispro infusion rates and multiple daily insulin injection with lispro and glargine
• Scientific title: Comparison between continuous subcutaneous insulin infusion with multiple basal lispro infusion rates and multiple daily insulin injection with lispro and glargine
• Date of first enrolment: 24/07/2003
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN37153662
• Study type: Interventional
• Study design: Multicentre, randomised, cross-over study (Treatment)
• Phase: Not Specified

Countries of recruitment

Italy

Contacts

• Name: Daniela Bruttomesso

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Diabetes mellitus type one
Nutritional, Metabolic, Endocrine
Diabetes mellitus

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Disetronic Medical Systems AG (Switzerland)

Ethics review

Status:
Approval date:
Contact:

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).

Results

• Results available: Yes
• Date Completed: 16/05/2005