DailyDose App for Type 1 Diabetes

(AB-CDE Trial)

Not yet recruiting at 5 trial locations
LW
ST
Overseen BySamrita Thapa
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Oregon Health and Science University
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called DailyDose, which helps manage type 1 diabetes by tracking glucose levels, insulin use, and exercise. The app provides personalized advice on insulin and carb intake, especially during exercise or low blood sugar events, to help lower blood sugar levels. Participants with type 1 diabetes for at least a year and who use multiple daily insulin injections might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to use the study insulin and devices. If you're on a stable dose of non-insulin glucose-lowering medication, you can continue as long as there are no plans to change it during the study.

What prior data suggests that the DailyDose app is safe for managing Type 1 Diabetes?

Research has shown that DailyDose, a smartphone app for managing type 1 diabetes, is safe to use. Studies have found that it provides real-time advice on insulin doses and helps improve blood sugar control. Importantly, these studies reported no major safety issues. Additionally, since DailyDose is neither a drug nor a surgical treatment, it is less likely to cause harmful side effects. The app uses data from blood sugar monitors, insulin use, and exercise to offer personalized advice. Overall, research indicates that DailyDose is safe and well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about the DailyDose app for Type 1 Diabetes because it offers a new way to manage the condition by integrating continuous glucose monitoring (CGM) with personalized counseling. Unlike traditional methods that primarily rely on multiple daily injections (MDI) of insulin, DailyDose combines technology and expert guidance, potentially improving control and quality of life for users. The app's data-driven approach allows for real-time adjustments, which could lead to better overall glucose management compared to standard care options.

What evidence suggests that the DailyDose app is effective for managing Type 1 Diabetes?

Research shows that the DailyDose app uses artificial intelligence (AI) to analyze blood sugar levels and suggest ways to manage Type 1 diabetes. In this trial, participants in the intervention group will use DailyDose alongside a continuous glucose monitor (CGM) and may receive counseling if needed. Users of similar apps with connected glucose meters have experienced better blood sugar control. However, some studies found that DailyDose itself did not improve blood sugar levels compared to baseline. Despite this, users who followed the app's personalized advice noticed benefits. This suggests that DailyDose's effectiveness may depend on how closely users follow its suggestions.26789

Who Is on the Research Team?

LW

Leah Wilson, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who are interested in managing their condition using a new smartphone app called DailyDose. The app aims to assist with insulin dosing and carbohydrate intake recommendations by tracking glucose, insulin use, and exercise.

Inclusion Criteria

Able to read, write and understand spoken English
HbA1c or GMI 7.5-11.5% at screening
I have been using insulin injections multiple times a day for at least 30 days.
See 5 more

Exclusion Criteria

I have an active foot ulcer.
I am not on long-term immunosuppressive medication.
Known or suspected abuse of alcohol, narcotics, or illicit drugs
See 23 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants use the Dexcom G6 CGM system, insulin dose capture system, and DailyDose app in Data-logging Mode for 2 weeks at home

2 weeks
1 visit (in-person) for training

Intervention/Control

Participants are randomized to either the intervention group using DailyDose or the control group using Data-logging Mode for 12 weeks

12 weeks
Regular data collection and monitoring

Adjustment

Participants receive DSMES and behavioral health interventions if needed, based on TIR and hypoglycemia metrics, for 12 weeks

12 weeks

Sustainability Assessment

All participants use DailyDose to assess sustainability of glycemic improvements for a final 12-week period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DailyDose

Trial Overview

The study investigates the effectiveness of the DailyDose app as a decision support tool for people with Type 1 Diabetes. It evaluates whether using the app can lead to better blood sugar control as indicated by HbA1c levels.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Leona M. & Harry B. Helmsley Charitable Trust

Collaborator

Citations

Artificial intelligence, diabetes experts combine forces for ...

The DailyDose app, which uses an artificial intelligence, or AI, algorithm to evaluate blood sugar data, identify concerning trends and recommend steps to help ...

Evaluation of a Prediction-Based Bedtime Intervention in ...

In this study, DailyDose collected and reported Dexcom G6 data comparably to the Dexcom G6 monitoring system used in the control arm.

Technology-Driven Diabetes Care: Real-World Evidence ...

Conclusion: Real-world data demonstrated improvements in glycemic metrics among 3790 PWDs using a mobile app with a connected glucose meter.

Assessment of a Decision Support System for Adults ...

Conclusion. Use of DailyDose did not improve glycemic outcomes compared to the baseline period. In a post hoc analysis, accepting and following recommendations ...

App-Based Certified Diabetes Education Therapy (AB-CDE)

DailyDose tracks your continuous glucose monitoring (CGM) data, insulin use, and exercise, and uses this information to provide personalized recommendations for ...

Assessment of a Decision Support System for Adults with ...

DailyDose is a decision support system designed to provide real-time dosing advice and weekly insulin dose adjustments for adults living with type 1 diabetes ...

OHSU # 2704 — DailyDose decision support algorithm ...

The DailyDose algorithm provides an artificial intelligence decision support system for improved management of blood glucose in patients with type 1 diabetes.

A digitally-enabled service model for team-based diabetes ...

The DailyDose app, designed by HHF in collaboration with researchers at Oregon Health Sciences University (OHSU), is a tool that helps people with type 1 ...

Using AI to Improve Glucose Outcomes: OHSU's DailyDose ...

Daily dose has been shown to improve glucose outcomes in people with type 1 diabetes.