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

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.

Study Overview

• Status: Completed
• Conditions: T1DM

• Study Type: Observational
• Enrollment (Actual): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical difficulties differences	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	2 years from patient first enrollment
Quality Of Life (QOL)	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.	2 years from patient first enrollment
Skin reactions differences	skin assessment at the pump insertion site (itching and redness).	2 years from patient first enrollment
Discontinuation rate differences	Comparison between constant pump users and those who discontinued	2 years from patient first enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control and metabolic parameters differences: Insulin TDD	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	2 years from patient first enrollment
Glycemic control and metabolic parameters differences: HbA1c%	The difference in HbA1c% as measured by each center ll local lab.	2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Glucose Mean & SD	Glucose Mean & SD as recorded by SMBG	2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Number of SMBG per day	Data derived from data recorded by SMBG	2 years from patient first enrollment
Glycemic control and metabolic parameters differences:BMI SDS	according to Center for Disease Control (CDC) growth charts scale	2 years from patient first enrollment

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Collaborators: Sheba Medical Center; Wolfson Medical Center; Maccabi Healthcare Services, Israel

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2015
• Primary Completion (ACTUAL): July 31, 2017
• Study Completion (ACTUAL): August 31, 2017

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (ACTUAL): October 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 0073-15-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes