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

University of Toronto

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Mini Link REAL-Time Transmitter

Study type: Interventional

Funder types: Other

Identifiers

NCT02137031

27225

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts 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

Trial design

40 participants in 1 patient group

Mini Link REAL-Time Transmitter

Experimental group

Treatment:

Device: Mini Link REAL-Time Transmitter