NCT03093636

Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 15 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to reduce the frequency of hypoglycemia and severe hypoglycemic events in subjects who use insulin pens to treat their Type 1 Diabetes Mellitus (T1DM). Hypoglycemia is the number one fear of many individuals and families with someone who has type 1 diabetes, and this fear often prevents optimal glycemic control. It is expected that this protocol will yield increased knowledge about using a decision support system to help control the glucose level.

Detailed description

This study is a 12-week parallel group multi-center randomized trial designed to compare CGM+DSS with CGM alone. The DSS to be implemented contains a "smart" bolus advisor that adjusts the size of correction insulin boluses based on short term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. inControl-Advice, a smart-phone based medical software platform, is designed to provide advice to users. It receives data from an insulin pen and then adjustments the insulin delivery every 5 minutes. The system provides a series of real-time alerts and on-demand advice, for both dosing of insulin and ingestion of carbohydrates, based on data collected from T1DM patients (i.e. carbohydrate consumption, insulin injected, CGM) and inConrol Cloud analytics.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor (CGM)+Decision Support System (DSS)	Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App and a study CGM at home for 12 weeks. The DSS contains a "smart" bolus advisor that adjusts the size of the correction insulin boluses based on short-term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. Subjects will use study basal and bolus insulin during the study.
OTHER	Continuous Glucose Monitor (CGM) alone	Continuous Glucose Monitor (CGM) alone study participants will use a study CGM at home for 12 weeks. Subjects will use study basal and bolus insulin during the study.

Timeline

• Start date: 2017-04-17
• Primary completion: 2019-03-19
• Completion: 2019-03-19
• First posted: 2017-03-28
• Last updated: 2022-11-18
• Results posted: 2022-11-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study