Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps

Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps

Sponsors

Lead sponsor: Assaf-Harofeh Medical Center

Collaborator: Wolfson Medical Center
Sheba Medical Center
Maccabi Healthcare Services, Israel

Source 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.

Overall Status Completed
Start Date May 31, 2015
Completion Date August 31, 2017
Primary Completion Date July 31, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Technical difficulties differences 2 years from patient first enrollment
Quality Of Life (QOL) 2 years from patient first enrollment
Skin reactions differences 2 years from patient first enrollment
Discontinuation rate differences 2 years from patient first enrollment
Secondary Outcome
Measure Time Frame
Glycemic control and metabolic parameters differences: Insulin TDD 2 years from patient first enrollment
Glycemic control and metabolic parameters differences: HbA1c% 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Glucose Mean & SD 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Number of SMBG per day 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:BMI SDS 2 years from patient first enrollment
Enrollment 60
Condition
Eligibility

Sampling method: Non-Probability Sample

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 -

Gender: All

Minimum age: N/A

Maximum age: 21 Years

Healthy volunteers: No

Verification Date

October 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Observation group

Description: 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.

Patient Data Undecided
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov