Clinical trial NCT03697369: Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
Official title: Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T1DM
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Wolfson Medical Center
name: Sheba Medical Center
name: Maccabi Healthcare Services, Israel
First posted: 2018-10-05
Enrollment: 60
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included all individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care, and were managed by the pediatric diabetes teams from the AWeSoMe Study Group ( four pediatric diabetes multidisciplinary clinics in Israel; Assaf Harofeh Medical Center, E. Wolfson Medical Center, Edmond and Lily Safra Children's Hospital, and Maccabi National Juvenile Diabetes 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.


Eligibility 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 -

Primary outcomes:
measure: Technical difficulties differences
timeFrame: 2 years from patient first enrollment
measure: Quality Of Life (QOL)
timeFrame: 2 years from patient first enrollment
measure: Skin reactions differences
timeFrame: 2 years from patient first enrollment
measure: Discontinuation rate differences
timeFrame: 2 years from patient first enrollment
Secondary outcomes:
measure: Glycemic control and metabolic parameters differences: Insulin TDD
timeFrame: 2 years from patient first enrollment
measure: Glycemic control and metabolic parameters differences: HbA1c%
timeFrame: 2 years from patient first enrollment
measure: Glycemic control and metabolic parameters differences:Glucose Mean & SD
timeFrame: 2 years from patient first enrollment
measure: Glycemic control and metabolic parameters differences:Number of SMBG per day
timeFrame: 2 years from patient first enrollment
measure: Glycemic control and metabolic parameters differences:BMI SDS
timeFrame: 2 years from patient first enrollment
Other outcomes:
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