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

NCT ID: NCT02137031

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-04-30

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

Study Design

• Primary Study Purpose: TREATMENT

Study Groups

Mini Link REAL-Time Transmitter

Group Type: EXPERIMENTAL

Mini Link REAL-Time Transmitter

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Krystie Robinson-Vincent

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krystie A Robinson-Vincent, PhD c

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Royal Victoria Hospital

Barrie, Ontario, Canada

Charles H. Best Centre

Whitby, Ontario, Canada

Countries

Canada

Other Identifiers

27225

Identifier Type: -

Identifier Source: org_study_id