Type 1 Diabetes Mellitus Clinical Trial
Official title:
Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management
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.
n/a
Primary Purpose: Treatment
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