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

Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Mini Link REAL-Time Transmitter

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Hospital
    • Whitby, Ontario, Canada, L1M 1Z5
      • Charles H. Best Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mini Link REAL-Time Transmitter	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Metabolic control as measured by standard HbA1c	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Krystie A Robinson-Vincent, PhD c, University of Toronto

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 9, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 9, 2014
• Last Verified: May 1, 2014

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: 27225