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Completed

NCT Number: NCT02137031

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Hospital, Barrie, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini Link REAL-Time Transmitter

Device

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

Primary outcomes

  1. HbA1c

    Time frame: 3 months

    Metabolic control as measured by standard HbA1c

Secondary outcomes

  1. Fear of Hypoglycemia

    Time frame: 3 months

    Fear of Hypoglycemia as measured by Children's Hypoglycemia Index

  2. Frequency of Hypoglycemia

    Time frame: 3 months

    The number of hypoglycemic episodes experienced per person over three months

  3. Frequency of Hyperglycemia

    Time frame: 3 months

    Number of hyperglycemic episodes per person over the course of 3 months

  4. Frequency of Diabetic Ketoacidosis

    Time frame: 3 months

    Frequency of Diabetic Ketoacidosis episodes per person over the course of 3 months

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management

Acronym: CHILD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 13, 2014
Registry last updated
May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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