Trials / Completed
CompletedNCT03697369
Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Assaf-Harofeh Medical Center · Other Government
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices. Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use . Methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.
Conditions
Timeline
- Start date
- 2015-05-31
- Primary completion
- 2017-07-31
- Completion
- 2017-08-31
- First posted
- 2018-10-05
- Last updated
- 2018-10-05
Source: ClinicalTrials.gov record NCT03697369. Inclusion in this directory is not an endorsement.