At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adjusting Insulin Delivery to Activity (AIDA)
In Brief
A clinical study evaluating Dexcom G4 Platinum CGM and Activity monitor for Diabetes and Nocturnal Hypoglycemia. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Increased daytime activity in children and adolescents with type I diabetes is known to be associated with overnight hypoglycemia. We therefore wish to perform a prospective clinical study to assess the feasibility of using activity monitor data to adjust insulin pump basal rates and see whether we can help prevent overnight hypoglycemia or decrease related interventions following high activity days. We plan to carry this out by enrolling 20 subjects (10 subjects 1 to \<7 years old and 10 subjects 7 to 17 years old) with type 1 diabetes managed on insulin pump therapy and having them wear activity monitors and CGMs for up to 3 months. After an initial two-week period to establish activity baselines, we will recommend nighttime basal insulin rate adjustments based on activity monitor, CGM and insulin pump data.
Study Details
Timeline
Interventions
Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.