Comparison in metabolic control and treatment satisfaction with continuous subcutaneous insulin infusion and multiple daily injections in children at onset of type 1 diabetes mellitus
ISRCTN | ISRCTN64351161 |
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DOI | https://doi.org/10.1186/ISRCTN64351161 |
Secondary identifying numbers | N/A |
- Submission date
- 29/04/2007
- Registration date
- 03/07/2007
- Last edited
- 16/05/2019
- 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 Lars Skogsberg
Scientific
Scientific
Pediatric Clinic
Gävle Hospital
Gävle
S-80187
Sweden
lars.skogsberg@lg.se |
Study information
Study design | Open, randomized, parallel group study. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | Comparison in metabolic control and treatment satisfaction with continuous subcutaneous insulin infusion and multiple daily injections in children at onset of type 1 diabetes mellitus |
Study objectives | To compare treatment satisfaction with Continuous Subcutaneous Insulin Infusion (CSII) and Multiple Daily Injections (MDI) in newly diagnosed diabetic children and adolescents. Our outcome measurements are metabolic control, safety and treatment satisfaction. |
Ethics approval(s) | Uppsala University (Sweden), approved on 11th October 2001 (ref: Ups dnr 01-347) |
Health condition(s) or problem(s) studied | Type 1 diabetes mellitus |
Intervention | Group 1: Continuous subcutaneous insulin infusion for 24 months Group 2: Multiple daily insulin injections for 24 months |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | insulin |
Primary outcome measure | The following were measured at baseline, 1 month, 6, 12 and 24 months: 1. Metabolic control (HbA1c) 2. Treatment satisfaction (Qestionnaires Diabetes Treatment Satisfaction Questionnaire [DTSQ]) 3. Safety (Registration of hospitalization for ketoacidosis [defined as pH <7.3] and major hypoglycemic episodes and/or technical problems) |
Secondary outcome measures | The following were measured at baseline, 1 month, 6, 12 and 24 months: 1. BMI 2. Isulin requirment 3. Adverse events 4. C-petide 5. insulin-like growth factor-1 (IGF-1) 6. Binding proteins |
Overall study start date | 01/12/2001 |
Completion date | 31/05/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 7 Years |
Upper age limit | 17 Years |
Sex | Not Specified |
Target number of participants | 72 patients |
Total final enrolment | 72 |
Key inclusion criteria | Children and adolescents (age 7 to 17 years) with newly diagnosed (within 3 weeks) type 1 diabetes mellitus. |
Key exclusion criteria | Other relavent diseases. |
Date of first enrolment | 01/12/2001 |
Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Pediatric Clinic
Gävle
S-80187
Sweden
S-80187
Sweden
Sponsor information
County of Gävleborg (Sweden)
Government
Government
Gävle Hospital
Gävle
S-80187
Sweden
Website | http://www.lg.se |
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Funders
Funder type
Government
Research and Development Center, County of Gävleborg (Sweden)
No information available
Foundation for Children with Diabetes (Barndiabetesfonden) (Sweden)
No information available
Results and Publications
Intention to publish date | |
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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 | results | 01/10/2008 | 16/05/2019 | Yes | No |
Editorial Notes
16/05/2019: Publication reference and total final enrolment added.