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

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Mini Link REAL-Time Transmitter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mini Link REAL-Time Transmitter<br> | Device: Mini Link REAL-Time Transmitter<br>* Children used the Mini Link REAL-Time Transmitter to measure glucose continuously for a minimum of three days per week for three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Metabolic control as measured by standard HbA1c | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Hypoglycemia | Fear of Hypoglycemia as measured by Children's Hypoglycemia Index | 3 months | 
| Frequency of Hypoglycemia | The number of hypoglycemic episodes experienced per person over three months | 3 months | 
| Frequency of Hyperglycemia | Number of hyperglycemic episodes per person over the course of 3 months | 3 months | 
| Frequency of Diabetic Ketoacidosis | Frequency of Diabetic Ketoacidosis episodes per person over the course of 3 months | 3 months |