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

T1DM Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697369
• Other study ID #: 0073-15-ASF
• Status: Completed
• Start date: May 31, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2018
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• T1DM

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center	Maccabi Healthcare Services, Israel, Sheba Medical Center, Wolfson Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Skin reactions differences	skin assessment at the pump insertion site (itching and redness).	2 years from patient first enrollment
Primary	Discontinuation rate differences	Comparison between constant pump users and those who discontinued	2 years from patient first enrollment
Secondary	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
Secondary	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
Secondary	Glycemic control and metabolic parameters differences:Glucose Mean & SD	Glucose Mean & SD as recorded by SMBG	2 years from patient first enrollment
Secondary	Glycemic control and metabolic parameters differences:Number of SMBG per day	Data derived from data recorded by SMBG	2 years from patient first enrollment
Secondary	Glycemic control and metabolic parameters differences:BMI SDS	according to Center for Disease Control (CDC) growth charts scale	2 years from patient first enrollment