Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/04/2007
Date assigned
03/07/2007
Last edited
04/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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 measures

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

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

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

http://www.lg.se

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes