Continuous Glucose Monitoring and Metabolic Control in Children With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— CHILD  

Official title:

Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137031
• Other study ID #: 27225
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: May 9, 2014
• Start date: September 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this pilot randomized controlled trial is to provide preliminary indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine participants' satisfaction with allocated treatment.

With increased and immediate information related to current and future (trend) glucose information provided by the continuous glucose monitor, children can then act upon this knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c levels.

Research on the effectiveness of continuous glucose monitoring on metabolic control in children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore, a pilot clinical trial will be designed to provide preliminary indicators of the feasibility and acceptability of continuous glucose monitoring on metabolic control and address the following objectives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children aged 6-18 years

• T1D for greater than one year;

• Willing to perform at least three self-monitoring blood glucose tests per day;

• Has been using continuous subcutaneous insulin infusion for more than one month

• English speaking

Exclusion Criteria:

• Presence of celiac disease (can cause malabsorption of nutrients affecting metabolic control)

• Use of corticosteroids that have systemic effects and affect glucose levels

• Currently using continuous glucose monitoring

• Cognitively unable to self-manage, based on parent's and/or care provider's opinion

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Mini Link REAL-Time Transmitter
Children used the Mini Link REAL-Time Transmitter to measure glucose continuously for a minimum of three days per week for three months.

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Barrie	Ontario
Canada	Charles H. Best Centre	Whitby	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Metabolic control as measured by standard HbA1c	3 months	No
Secondary	Fear of Hypoglycemia	Fear of Hypoglycemia as measured by Children's Hypoglycemia Index	3 months	No
Secondary	Frequency of Hypoglycemia	The number of hypoglycemic episodes experienced per person over three months	3 months	No
Secondary	Frequency of Hyperglycemia	Number of hyperglycemic episodes per person over the course of 3 months	3 months	No
Secondary	Frequency of Diabetic Ketoacidosis	Frequency of Diabetic Ketoacidosis episodes per person over the course of 3 months	3 months	No