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

Shamir Medical Center (Assaf-Harofeh)

Status: Completed

Conditions: T1DM

Study type: Observational

Funder types: Other

Identifiers

NCT03697369

0073-15-ASF

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

60 participants in 1 patient group

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.