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

NCT03093636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-11-18

Study results available
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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.

Conditions

  • Type1 Diabetes Mellitus

Interventions

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.

Sponsors & Collaborators

  • TypeZero Technologies

    collaborator INDUSTRY

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • DexCom, Inc.

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Stacey M. Anderson, MD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2019-03-19
Completion
2019-03-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093636 on ClinicalTrials.gov