- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217369
Impacts of Glucose Forecasting
Impacts of Estimated Future Glucose Values on Health
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- An individual with type I or type II diabetes treated with > 1 insulin injections
- Currently using a smartphone compatible with the Diabits app
- Are willing to, or already wear a CGM which is compatible with the Diabits app
- Willing and able to provide informed consent, to have their data collected, and to complete questionnaires that are included as part of the protocol.
- HbA1c between 7.5 - 10 % ( 86 - 58 mmol/mol)
Exclusion Criteria:
- Patients who are pregnant or are planning to become pregnant during the duration of the study.
- Patients with major psychiatric illness or severe end-stage diabetes complications.
- Patients who use sensor-augmented pumps with automated features such as hybrid closed loop or predictive insulin suspension. This includes those who use non-commercial software such as DIY closed loop.
- Patients with prior use of the Diabits app
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
A control arm.
The participant will be given a version of the Diabits app without predictions of blood glucose enabled.
They will then use the Diabits app as if they were using their usual companion app to manage their diabetes for the duration of the study.
|
|
Experimental: Intervention
The intervention arm.
The participants in this arm will be provided with a version of the Diabits app which provides predictions of where their blood glucose will be one hour into the future, based on historic data and user inputs.
The participant will then manage their blood glucose using these predictions for the duration of the study.
|
Participants will be able to view predictions of future blood glucose.
These predictions will indicate where the participant's blood glucose will travel over the next hour given that the participant's state does not change.
Based on this, the participant is expected, but not required to make decisions about their activity, food, and insulin, in order to maintain blood glucose in a healthy range.
The intervention does not require a specific method of glucose management, or event that a participant takes any action after viewing a prediction, the intervention is simply to display the prediction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time in Range
Time Frame: One day
|
The proportion of time in a single day in which a given participant's blood glucose is within a predetermined target blood glucose range.
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BGL variability (SD) BGL variability (SD)
Time Frame: 1 day
|
The standard deviation from the mean of the participant's blood glucose
|
1 day
|
BGL Variability (ADRR)
Time Frame: 14 days
|
Average Daily Risk Range, a measure of variability which assesses two weeks of data to identify risk of out-of-range events.
|
14 days
|
Time below range
Time Frame: 1 day
|
A proportion of time where the participant's blood glucose is below 3.9 mmol/L, and is below 3.0 mmol/L, respectively
|
1 day
|
Change is HbA1c
Time Frame: 14 days
|
A calculated metric which is an analogue to a laboratory HbA1c measure, to assess the likelihood of measurable changes in HbA1c
|
14 days
|
Laboratory HbA1c
Time Frame: 90 days
|
A blood test which measures hemoglobin A1c, an indicator of long term tissue damage
|
90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019 (Chief Medical Office (CMO) Alberta Health Services)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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