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

ISRCTN ISRCTN37153662
DOI https://doi.org/10.1186/ISRCTN37153662
Secondary identifying numbers N/A
Submission date
18/04/2007
Registration date
25/04/2007
Last edited
22/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniela Bruttomesso
Scientific

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

Study information

Study designMulticentre, randomised, cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleComparison between continuous subcutaneous insulin infusion with multiple basal lispro infusion rates and multiple daily insulin injection with lispro and glargine
Study objectivesBlood glucose variability is lower during Continuous Subcutaneous Insulin Infusion (CSII) as compared to Multiple Daily Insulin injection (MDI) with Glargine.
Ethics approval(s)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).
Health condition(s) or problem(s) studiedDiabetes mellitus type one
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Lispro, glargine
Primary outcome measureBlood glucose variability as measure by standard deviation of mean blood glucose.

Data of the last month of each treatment period were analysed.
Secondary outcome measures1. 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 study start date24/07/2003
Completion date16/05/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexNot Specified
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment24/07/2003
Date of final enrolment16/05/2005

Locations

Countries of recruitment

  • Italy

Study participating centre

Azienda Ospedaliera di Padova
Padova
35128
Italy

Sponsor information

Disetronic Medical Systems AG (Switzerland)
Industry

Kirchbergstrasse 190
Burgdorf
3401
Switzerland

Website http://www.disetronic.com
ROR logo "ROR" https://ror.org/00by1q217

Funders

Funder type

Industry

Disetronic Medical Systems AG (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 27/02/2008 22/09/2021 Yes No

Editorial Notes

22/09/2021: Publication reference added.