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Assessment of a Decision Support Tool in Participants With Type 1 Diabetes

NCT04428645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-07-19

Study results available
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Summary

Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia which can lead to severe acute and chronic complications. The burden and complexity of managing T1D results in the majority of people not reaching adequate glycemic control. Our team has developed a smartphone based application, DailyDose, that combines continuous glucose monitoring data and insulin data to provide decision support for subjects with type 1 diabetes taking multiple daily injections (MDI). DailyDose provides on-demand, real-time dosing recommendations for insulin doses prior to meals and to correct hyperglycemia. DailyDose analyzes glucose patterns and provides weekly recommendations to the patient on insulin settings including carbohydrate ratios and correction factors. As needed, DailyDose will make weekly recommendations to change basal insulin. For subject safety, study investigators will set constraints on settings for short and long acting insulin during the onboarding process. DailyDose will not be able to recommend insulin dose changes above or below the set safety thresholds. DailyDose also provides recommendations on carbohydrate intake for exercise and includes hypoglycemia and hyperglycemia alarms.

Conditions

Interventions

DEVICE

DailyDose Decision Support

DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Peter Jacobs, PhD · Oregon Health and Science University

  • Jessica Castle, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2021-11-15
Completion
2021-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04428645 on ClinicalTrials.gov