NCT02558491

Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Daniel Chernavvsky, MD · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump.

Detailed description

The overall aim of this proposed research is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump. The system will be deployed on our portable medical application platform (DiAs) and will include insulin pump treatment parameters optimization and an exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment. A second phase of the trial will enroll additional users of insulin pumps, and subjects who treat their T1DM with the use of multiple daily injections (MDI) of insulin. MDI users should be administering the Lantus (glargine) dose at approximately the same time each day and use only one basal rate per day. MDI users will also use MySugr app to count carbohydrates for all meals that require insulin treatment.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Decision Support System	The purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing glucose variability in T1DM patient using an insulin pump or MDI. The system will be deployed on our portable medical application platform (DiAs) and will include the following elements: 1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data 2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment. 3. A smart bolus calculator based on CGM glucose measurements and insulin sensitivity estimation.
OTHER	Usual Care	During the Control study admission, DiAs will be programmed with the home insulin dosing parameters. The study subject will use the home basal/bolus MDI or continuous subcutaneous insulin infusion (CSII) insulin regimen via the home insulin pens or pump and determine the amount of insulin to give for the entire admission per the subject's home carb counting parameters and as calculated by the DiAs meal screen.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-09-24
• Last updated: 2024-08-07
• Results posted: 2023-03-23

Locations

1 site across 1 country: United States