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
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

Pediatric Clinic
Gävle Hospital
Gävle
S-80187
Sweden

lars.skogsberg@lg.se

Study information

Study designOpen, randomized, parallel group study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleComparison 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 objectivesTo 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) studiedType 1 diabetes mellitus
InterventionGroup 1: Continuous subcutaneous insulin infusion for 24 months
Group 2: Multiple daily insulin injections for 24 months
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)insulin
Primary outcome measureThe 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 measuresThe 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 date01/12/2001
Completion date31/05/2006

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit7 Years
Upper age limit17 Years
SexNot Specified
Target number of participants72 patients
Total final enrolment72
Key inclusion criteriaChildren and adolescents (age 7 to 17 years) with newly diagnosed (within 3 weeks) type 1 diabetes mellitus.
Key exclusion criteriaOther relavent diseases.
Date of first enrolment01/12/2001
Date of final enrolment31/05/2006

Locations

Countries of recruitment

  • Sweden

Study participating centre

Pediatric Clinic
Gävle
S-80187
Sweden

Sponsor information

County of Gävleborg (Sweden)
Government

Gävle Hospital
Gävle
S-80187
Sweden

http://www.lg.se

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
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 results 01/10/2008 16/05/2019 Yes No

Editorial Notes

16/05/2019: Publication reference and total final enrolment added.

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