At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
In Brief
A clinical study evaluating SAP and CLC for Type 1 Diabetes Mellitus and Cognitive Change. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.
Study Details
Timeline
Interventions
Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.