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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	N/A
Sponsor	County of Gävleborg (Sweden)
Funders	Research and Development Center, County of Gävleborg (Sweden), Foundation for Children with Diabetes (Barndiabetesfonden) (Sweden)

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

Email	lars.skogsberg@lg.se

Study information

Primary study design	Interventional
Study design	Open, randomized, parallel group study.
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	insulin
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/05/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	17 Years
Sex	Not Specified
Target sample size at registration	72
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.