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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mini Link REAL-Time Transmitter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Metabolic control as measured by standard HbA1c | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krystie A Robinson-Vincent, PhD c | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Barrie | Ontario | L4M 6M2 | Canada | ||
| Charles H. Best Centre |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| Whitby |
| Ontario |
| L1M 1Z5 |
| Canada |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |