Contact information
Type
Scientific
Primary contact
Dr Lars Skogsberg
ORCID ID
Contact details
Pediatric Clinic
Gävle Hospital
Gävle
S-80187
Sweden
-
lars.skogsberg@lg.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Uppsala University (Sweden), approved on 11th October 2001 (ref: Ups dnr 01-347)
Study design
Open, randomized, parallel group study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
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 trial start date
01/12/2001
Overall trial end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children and adolescents (age 7 to 17 years) with newly diagnosed (within 3 weeks) type 1 diabetes mellitus.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
72 patients
Total final enrolment
72
Participant exclusion criteria
Other relavent diseases.
Recruitment start date
01/12/2001
Recruitment end date
31/05/2006
Locations
Countries of recruitment
Sweden
Trial participating centre
Pediatric Clinic
Gävle
S-80187
Sweden
Sponsor information
Organisation
County of Gävleborg (Sweden)
Sponsor details
Gävle Hospital
Gävle
S-80187
Sweden
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Research and Development Center, County of Gävleborg (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation for Children with Diabetes (Barndiabetesfonden) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18721168 (added 16/05/2019)