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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03697369

Enrollment

Registered

2018-10-05

Start date

2015-05-31

Completion date

2017-08-31

Last updated

2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T1DM

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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: 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: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

Outcome results