Safety and Feasibility Study of the Eddii Mobile Application

Type-1 Diabetes Clinical Trial

Official title:

A Safety and Feasibility Study of the Eddii Mobile Application for Glucose Monitoring in Pediatric Patients With Type I Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05205876
• Other study ID #: LeafStudy
• Status: Completed
• Phase: N/A
• Start date: January 2, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2022
• Source: Eddii, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to measure the safety and feasibility of the Eddii mobile app for children living with Type-1 diabetes and using a CGM (Continuous Glucose monitor).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type-1 Diabetes

Intervention

Behavioral:
• Eddii mobile application
Participants will use the Eddii mobile application in the intervention arm.

Locations

Country	Name	City	State
United States	Eddii, inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eddii, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the Eddii App as assessed by accuracy and reliability of blood glucose measurements	Safety (Intervention Arm only) as assessed by: ? Functionality and reliability of Eddii application by measuring reported faults	Eight Weeks
Primary	Feasibility of the Eddii App as measured by frequency of use	Feasibility (Intervention Arm only) as measured by: App analytics to determine total number and frequency of logins from enrollment to Week 8; App analytics to determine application features are easily accessible, understandable and are used effectively	Four Weeks
Secondary	Change in glycaemic control measured as Time-in-Range (TIR) (70-180mg/dl)		Eight Weeks
Secondary	QOL (Quality of Life) metrics	- QOL questionnaires conducted mid-study on weeks 2, 4, 6 and 8	Eight Weeks
Secondary	User Engagement measured through app analytics	App-Specific Measures for Entirety of Study (Intervention Arm only); ? Engagement and retention of users	Eight Weeks