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
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 design | Multicentre, randomised, cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Comparison between continuous subcutaneous insulin infusion with multiple basal lispro infusion rates and multiple daily insulin injection with lispro and glargine |
| Study objectives | Blood 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lispro, glargine |
| Primary outcome measure | 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 study start date | 24/07/2003 |
| Completion date | 16/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/07/2003 |
| Date of final enrolment | 16/05/2005 |
Locations
Countries of recruitment
- Italy
Study participating centre
Azienda Ospedaliera di Padova
Padova
35128
Italy
35128
Italy
Sponsor information
Disetronic Medical Systems AG (Switzerland)
Industry
Industry
Kirchbergstrasse 190
Burgdorf
3401
Switzerland
| Website | http://www.disetronic.com |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
