Evaluation of Novel Trend Arrow Adjustment Tool for Diabetes Patients Using Continuous Glucose Monitoring to Guide Insulin Bolus Adjustment (TAAT Study) (TAAT)
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Insulin Infusion Systems, Blood Glucose
Eligibility Criteria
Inclusion Criteria:
- Participants will be children and youth aged 5-18 years, attending CHEO diabetes clinic
- Established Type 1 diabetes for more than 1 year,
- Who have used an insulin pump and CGM for at least 3 months.
- Willing to wear iPro2 blinded CGM and to use the Trend Arrow Adjustment Tool and the 10/20% bolus adjustment method.
- Internet access at home (to upload CGM data).
Exclusion Criteria:
- Conditions which may interfere with the subject's ability to participate in the study.
- Has received oral and/or intravenous steroid therapy (for any indication, at any dose and/or for any duration) on more than 2 separate occasions in the past 12 months. Use of inhaled and/or topical steroid therapy in the last 12 months does not exclude the subject
Sites / Locations
- Children's Hospital of Eastern Ontario
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Trend Arrow Adjustment Tool
10/20% bolus adjustment
No adjustment/ignore trend arrows
The Trend Arrow Adjustment Tool, uses a formula based on the patients Insulin Sensitivity Factor (ISF) to allow adjustments to meal time insulin boluses, based on CGM trend arrows.
10-20% increase/decrease of the total original recommended bolus dose (10% for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose calculated by the pump calculator (i.e. Bolus Wizard).
Subjects will ignore the CGM trend arrows, meal time bolus insulin as per Bolus Wizard