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

NCT02137031 | Completed DMC

• 1 other identifier: 27225
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Metabolic control as measured by standard HbA1c

  3 months

Secondary Outcomes (4)

• Fear of Hypoglycemia

  3 months

• Frequency of Hypoglycemia

  3 months

• Frequency of Hyperglycemia

  3 months

• Frequency of Diabetic Ketoacidosis

  3 months

Study Arms (1)

Mini Link REAL-Time Transmitter

EXPERIMENTAL

Device: Mini Link REAL-Time Transmitter

Interventions

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.

Mini Link REAL-Time Transmitter

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (2)

Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

Charles H. Best Centre

Whitby, Ontario, L1M 1Z5, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Krystie A Robinson-Vincent, PhD c

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 13, 2014
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

CA (2)