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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mini Link REAL-Time Transmitter
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Royal Victoria Hospital
  • Charles H. Best Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mini Link REAL-Time Transmitter

Arm Description

Outcomes

Primary Outcome Measures

HbA1c
Metabolic control as measured by standard HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
May 7, 2014
Last Updated
May 9, 2014
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02137031
Brief Title
Continuous Glucose Monitoring and Metabolic Control in Children With Type 1 Diabetes
Acronym
CHILD
Official Title
Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mini Link REAL-Time Transmitter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mini Link REAL-Time Transmitter
Intervention Description
Children used the Mini Link REAL-Time Transmitter to measure glucose continuously for a minimum of three days per week for three months.
Primary Outcome Measure Information:
Title
HbA1c
Description
Metabolic control as measured by standard HbA1c
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fear of Hypoglycemia
Description
Fear of Hypoglycemia as measured by Children's Hypoglycemia Index
Time Frame
3 months
Title
Frequency of Hypoglycemia
Description
The number of hypoglycemic episodes experienced per person over three months
Time Frame
3 months
Title
Frequency of Hyperglycemia
Description
Number of hyperglycemic episodes per person over the course of 3 months
Time Frame
3 months
Title
Frequency of Diabetic Ketoacidosis
Description
Frequency of Diabetic Ketoacidosis episodes per person over the course of 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krystie A Robinson-Vincent, PhD c
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Charles H. Best Centre
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1M 1Z5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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