Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462371
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2007-04-18
Brief Title:
Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Open-Label Randomised Trial Comparing Efficacy of Continuous Subcutaneous Insulin InfusionCSII and Multiple Daily Insulin Injections MDII in Improving Glycemic Control and Quality of Life in Poorly Regulated Type 1 Diabetic Children
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison between insulin pump treatment and multiple daily insulin injections in 38 children with type 1 diabetes4-16 years old Outcome metabolic control quality of life impact of disease and cost effectiveness
We hypothesised that insulin pump treatment would give a better metabolic control and quality of life
We hypothesised that insulin pump treatment would give a better metabolic control and quality of life
Detailed Description:
The current standard of insulin treatment in type 1 diabetes is multiple daily insulin injection therapy MDII In the seventies continuous subcutaneous insulin infusion CSII was introduced CSII has been gaining popularity perhaps because of technical advances resulting in improved patient comfort In children five randomised studies1-5 were completed to compare MDII and CSII No data were gained about quality of life and impact of disease
In our trial we focussed on quality of life next to metabolic control
The trial was an open-labelledrandomised trial Both efficacy and safety data were collected The trial started with a 14 weeks run in phase during all patients started MDIIIn the following randomisation phase patients were randomised to continue MDII or to CSIIThis phase lasted 14 weeksIn the phase thereafter all patients used CSII for 14 weeks The trial was concluded by a 14 weeks allocated patient preference phase
Patients were type 1 diabetic children 4-16 years old with poor metabolic controlhypothesis better metabolic control in CSII better quality of life in CSII
In our trial we focussed on quality of life next to metabolic control
The trial was an open-labelledrandomised trial Both efficacy and safety data were collected The trial started with a 14 weeks run in phase during all patients started MDIIIn the following randomisation phase patients were randomised to continue MDII or to CSIIThis phase lasted 14 weeksIn the phase thereafter all patients used CSII for 14 weeks The trial was concluded by a 14 weeks allocated patient preference phase
Patients were type 1 diabetic children 4-16 years old with poor metabolic controlhypothesis better metabolic control in CSII better quality of life in CSII
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None