DailyDose App for Type 1 Diabetes
(AB-CDE Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Intervention/Control
Participants are randomized to either the intervention group using DailyDose or the control group using Data-logging Mode for 12 weeks
Adjustment
Participants receive DSMES and behavioral health interventions if needed, based on TIR and hypoglycemia metrics, for 12 weeks
Sustainability Assessment
All participants use DailyDose to assess sustainability of glycemic improvements for a final 12-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
AB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated
Usual care including MDI insulin therapy with study CGM and DailyDose in Data-logging Mode.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
Leona M. & Harry B. Helmsley Charitable Trust
Collaborator
Citations
1.
news.ohsu.edu
news.ohsu.edu/2023/01/10/artificial-intelligence-diabetes-experts-combine-forces-for-blood-sugar-management-studyArtificial 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 ...
2.
diabetesjournals.org
diabetesjournals.org/care/article/48/10/1766/163047/Evaluation-of-a-Prediction-Based-BedtimeEvaluation 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.
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