- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05205876
Safety and Feasibility Study of the Eddii Mobile Application
A Safety and Feasibility Study of the Eddii Mobile Application for Glucose Monitoring in Pediatric Patients With Type I Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Wearable continuous glucose monitoring (CGM) sensors have revolutionized diabetes management over the past decade. By providing blood glucose (BG) concentration measurements continuously over consecutive days, CGMs are an increasingly adopted technology. While CGM devices have been shown to improve the safety and effectiveness of diabetes therapy to reduce hypoglycemia incidents and durability and to decrease glycemic variability CGM software and tools available for users to feel motivated and engaged are limited. Users of CGM often use an app that provides an interface for them to track their BG. In most cases, this app is offered by their CGM device provider.
These interfaces are considerably basic and scientific in nature, often developed by scientists and engineers for the everyday user. These apps are particularly dull and tiresome for children and adolescents living with diabetes. Current real-time CGM interfaces present real-time BG reading, in addition to the BG trend and a historical chart, together with minimal options for the user to enter lifestyle data such as medications, meals, and exercise. Examples of such default interfaces are ones offered by Dexcom, Medtronic Guardian and Freestyle Libre. While some of these apps provide patterns and health summaries to the user, these are provided in a separate app to the one streaming real-time BG. With the emergence of rtAPI (real-time Application Programming Interface) integrations with CGMs, there is ample opportunity to improve the dynamism, sophistication, and offerings within these CGM Apps , creating a platform that delights the user rather than one that makes diabetes management seem like a daily chore. Furthermore, it is hypothesized that creating additional engagement in the form of games and real-life rewards will improve glycemic control.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- Eddii, inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (Pediatric Volunteers)
Subject must meet all of the following to be enrolled.
- Volunteer, or their Authorized Representative, is willing and able to provide written informed consent, including authorization to release health information
- Volunteer is > 5 years and < 12 years of age (inclusive) at time of consent
- Volunteer has been diagnosed with Type 1 diabetes
- Volunteer has been utilizing the Dexcom continuous glucose monitor for a minimum of 6 months prior to enrollment in the study
- Volunteer must use the Dexcom mobile application
- Volunteer has a parent or legal guardian willing to participate in the study
- Volunteer must have access to and use an iOS smart phone, iPhone 10 model or above
Parent / Guardian Volunteers:
Subject must meet all of the following to be enrolled.
- Volunteer is willing and able to provide written informed consent, including authorization to release health information
- Volunteer has a child that meets study inclusion criteria and is willing to participate in the study
- Volunteer lives with a child that meets study inclusion criteria and is willing to participate in the study
- Volunteer is willing to be responsible for management of the Eddii mobile application use
- Volunteer must have and use an iOS smart phone device
Exclusion Criteria:
- EXCLUSION CRITERIA (Pediatric Volunteers)
Subject will be excluded if any of the below are present.
- Volunteer is unwilling or unable to provide written informed consent and/or does not have an authorized representative who can provide consent on their behalf
- Volunteer does not have access to an iOS smartphone device
- Volunteer does not have access to the internet
- Volunteer is enrolled in another research study at the time of enrollment
EXCLUSION CRITERIA (Parents / Guardians) Subject will be excluded if any of the below are present.
- Volunteer is unwilling or unable to provide written informed consent and/or does not have an authorized representative who can provide consent on their behalf
- Volunteer does not have access to an iOS smartphone device
- Volunteer does not have access to the internet
- Volunteer is enrolled in another research study at the time of enrollment
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 (Dexcom app)
This group will use the Dexcom application for management of their blood glucose for the duration of the study (8 weeks).
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|
Experimental: Intervention (Eddii app)
This group will use the Dexcom application for the initial 2 weeks of the study, and switch to using the Eddii application on Day 14 of the study for the remaining 6 weeks of the study.
|
Participants will use the Eddii mobile application in the intervention arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the Eddii App as assessed by accuracy and reliability of blood glucose measurements
Time Frame: Eight Weeks
|
Safety (Intervention Arm only) as assessed by: ○ Functionality and reliability of Eddii application by measuring reported faults |
Eight Weeks
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Feasibility of the Eddii App as measured by frequency of use
Time Frame: Four Weeks
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Feasibility (Intervention Arm only) as measured by:
|
Four Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in glycaemic control measured as Time-in-Range (TIR) (70-180mg/dl)
Time Frame: Eight Weeks
|
Eight Weeks
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QOL (Quality of Life) metrics
Time Frame: Eight Weeks
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- QOL questionnaires conducted mid-study on weeks 2, 4, 6 and 8
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Eight Weeks
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User Engagement measured through app analytics
Time Frame: Eight Weeks
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App-Specific Measures for Entirety of Study (Intervention Arm only) ○ Engagement and retention of users |
Eight Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Farhaneh Ahmadi, PhD, Eddii, inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- LeafStudy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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