Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/04/2007
Date assigned
25/04/2007
Last edited
25/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniela Bruttomesso

ORCID ID

Contact details

Azienda Ospedaliera di Padova
Dipartimento di Medicina Clinica e Sperimentale
Cattedra Malattie del Metabolismo
2
Via Nicolò Giustiniani
Padova
35128
Italy

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

http://www.disetronic.com

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

Publication citations

Additional files

Editorial Notes