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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Mini Link REAL-Time Transmitter

• Registration Number: NCT02137031
• Lead Sponsor: University of Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-09
• Last Update Submitted: 2014-05-09
• Study First Posted: 2014-05-13
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mini Link REAL-Time Transmitter	Mini Link REAL-Time Transmitter	-

Primary Outcome Measures

Name	Time	Method
HbA1c	3 months	Metabolic control as measured by standard HbA1c

Secondary Outcome Measures

Name	Time	Method
Fear of Hypoglycemia	3 months	Fear of Hypoglycemia as measured by Children's Hypoglycemia Index
Frequency of Hypoglycemia	3 months	The number of hypoglycemic episodes experienced per person over three months
Frequency of Hyperglycemia	3 months	Number of hyperglycemic episodes per person over the course of 3 months
Frequency of Diabetic Ketoacidosis	3 months	Frequency of Diabetic Ketoacidosis episodes per person over the course of 3 months

Trial Locations

Locations (2)

Charles H. Best Centre; 🇨🇦 Whitby, Ontario, Canada

Royal Victoria Hospital; 🇨🇦 Barrie, Ontario, Canada