Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
- Conditions
- T1DM
- Registration Number
- NCT03697369
- Lead Sponsor
- Assaf-Harofeh Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Diagnosis of T1D recorded by a pediatric endocrinologist
- Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017.
• No restrictions on HbA1c value at study recruitment or on use of CGMS -
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Discontinuation rate differences 2 years from patient first enrollment Comparison between constant pump users and those who discontinued
Technical difficulties differences 2 years from patient first enrollment All patients were asked 5 questions regarding monthly frequency of technical problems including the need to use extra sets and the level of pain at catheter insertion
Quality Of Life (QOL) 2 years from patient first enrollment QOL assessment was performed utilizing The Diabetes Treatment Satisfaction Questionnaires (DTSQ) for teens and for parents, separately \[14\]. The teens DTSQ contained 12 items scores on six-point scales, of which 9 were summed, the parents DTSQ contained 14 items, of which 9 were summed. Maximal grade was 42.
Skin reactions differences 2 years from patient first enrollment skin assessment at the pump insertion site (itching and redness).
- Secondary Outcome Measures
Name Time Method Glycemic control and metabolic parameters differences: HbA1c% 2 years from patient first enrollment The difference in HbA1c% as measured by each center ll local lab.
Glycemic control and metabolic parameters differences:Number of SMBG per day 2 years from patient first enrollment Data derived from data recorded by SMBG
Glycemic control and metabolic parameters differences:BMI SDS 2 years from patient first enrollment according to Center for Disease Control (CDC) growth charts scale
Glycemic control and metabolic parameters differences: Insulin TDD 2 years from patient first enrollment The difference in glycemic control parameters and metabolic parameters after 3, 6 and 12 months of follow up, between the pumps devices. Insulin TDD, as reported by pump printout data
Glycemic control and metabolic parameters differences:Glucose Mean & SD 2 years from patient first enrollment Glucose Mean \& SD as recorded by SMBG