Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observation group Individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care and were followed up prospectively in the next 12 months. |
Outcome Measures
Primary Outcome Measures
- 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).
- Discontinuation rate differences [2 years from patient first enrollment]
Comparison between constant pump users and those who discontinued
Secondary Outcome Measures
- 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: 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:Glucose Mean & SD [2 years from patient first enrollment]
Glucose Mean & SD as recorded by SMBG
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of T1D recorded by a pediatric endocrinologist
-
Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017.
Exclusion Criteria:
• No restrictions on HbA1c value at study recruitment or on use of CGMS -
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assaf-Harofeh Medical Center
- Wolfson Medical Center
- Sheba Medical Center
- Maccabi Healthcare Services, Israel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0073-15-ASF