NCT03674281

The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will evaluate up to 15 subjects in each age group for a period of 8-10 weeks performing neurocognitive tests before and after each intervention. The first study phase will be up to 2 weeks of a training period to allow participants to get acquainted with the use of the CGM if they are not familiar with the use of the device. This training period will be followed by a 4-week sensor-augmented pump (SAP) period using a study CGM and the subject's personal insulin pump. The subjects will return to clinic at the completion of the SAP period and will be trained on the Tandem t:slim X2 with Control-IQ and G6 CGM. At the completion of the system training session, subjects will begin 4-weeks of Closed-Loop Control (CLC). Questionnaires will be completed by the study subject at screening, after completion of SAP and after completion of CLC. Ecological Momentary Assessments (EMAs) and actigraphy data will be collected in the last 14 days of the SAP and CLC periods. A parent/guardian of the enrolled children will also be asked to participate in all trainings, complete parental Patient-Report Outcomes (PRO) Questionnaires, and collect sleep patterns while wearing the actigraph watch.

Conditions

• Type 1 Diabetes Mellitus
• Cognitive Change

Interventions

Type	Name	Description
DEVICE	SAP	Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
DEVICE	CLC	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.

Timeline

• Start date: 2018-09-24
• Primary completion: 2019-11-21
• Completion: 2019-11-21
• First posted: 2018-09-17
• Last updated: 2021-01-12
• Results posted: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study