Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-31 @ 2:21 AM
Study NCT ID:
NCT04217369
Status:
UNKNOWN
Last Update Posted:
2020-01-03
First Post:
2019-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impacts of Glucose Forecasting
Sponsor:
Bio Conscious Technologies Ltd
Organization:
Study Overview
Official Title:
Impacts of Estimated Future Glucose Values on Health
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study of individuals with type I or type II diabetes. It is meant to test the effect of using the Diabits app on a participant's blood glucose control. The Diabits app is a diabetes management app which integrates with your continuous glucose monitor (CGM) and presents not only your current blood glucose trend, but also an estimate of your blood glucose values up to 60 minutes into the future. The Diabits app has been available in the USA and Canada for the past two years and was validated for predictive accuracy at BC Children's Hospital in Canada in 2017 with a predicted accuracy of 94.9%. Diabits app users in North America have shown some improvements in their individual time in range (TIR) and HbA1c values. This study aims to validate those results in a clinical setting. The study will randomise a total of 90 participants into using the Diabits app with or without the glucose forecasting enabled to help determine if the glucose forecasting (or predictions) can help participants make better treatment decisions and improve not only measurements of glucose such as time in range and HbA1c, but also reduce anxiety and improve quality of life with diabetes.
Detailed Description:
This study focuses on the impact of the Diabits app, a smartphone application which assists a person with diabetes to better manage their blood glucose. The Diabits app connects to a user's continuous glucose monitor (CGM) such as an Abbott Freestyle Libre, and predicts what the user's blood glucose will be over the next 60 minutes, updating every 5 minutes. The Diabits app displays that prediction to the user so that the user may make proactive decisions about insulin and food, with the goal of achieving more stable blood glucose control.
The study will evaluate the impact which having access to blood glucose predictions has on a user's time in range (TIR). The hypothesis is that having access to blood glucose predictions will improve the user's ability to stay within their target blood glucose range by 5% within a given 24 hour period. This is a randomized controlled trial. A control group with Abbott Freestyle Libre CGMs will be recruited, and given a version of the Diabits app which does not display any blood glucose forecasts. A treatment group, also with Abbott Freestyle Libres, will be given the Diabits app with glucose forecasts enabled. Both groups will be asked to use the app as their primary diabetes management tool for the duration of the study.
The study will run for 3 months. At the beginning of the study the 90 participants will be separated evenly into two groups. A blood test will be done to measure HbA1c and each participant will complete a number of surveys. At the end of the study the same activities will occur. Following conclusion, results will be evaluated to determine what differences develop between the control and treatment groups.
The study will evaluate the impact which having access to blood glucose predictions has on a user's time in range (TIR). The hypothesis is that having access to blood glucose predictions will improve the user's ability to stay within their target blood glucose range by 5% within a given 24 hour period. This is a randomized controlled trial. A control group with Abbott Freestyle Libre CGMs will be recruited, and given a version of the Diabits app which does not display any blood glucose forecasts. A treatment group, also with Abbott Freestyle Libres, will be given the Diabits app with glucose forecasts enabled. Both groups will be asked to use the app as their primary diabetes management tool for the duration of the study.
The study will run for 3 months. At the beginning of the study the 90 participants will be separated evenly into two groups. A blood test will be done to measure HbA1c and each participant will complete a number of surveys. At the end of the study the same activities will occur. Following conclusion, results will be evaluated to determine what differences develop between the control and treatment groups.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: