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Safety and Feasibility Study of the Eddii Mobile Application

Primary Purpose

Type-1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Eddii mobile application

About this trial

This is an interventional supportive care trial for Type-1 Diabetes

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Eddii, inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control (Dexcom app)

Intervention (Eddii app)

Arm Description

This group will use the Dexcom application for management of their blood glucose for the duration of the study (8 weeks).

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Change in glycaemic control measured as Time-in-Range (TIR) (70-180mg/dl)

QOL (Quality of Life) metrics

- QOL questionnaires conducted mid-study on weeks 2, 4, 6 and 8

User Engagement measured through app analytics

App-Specific Measures for Entirety of Study (Intervention Arm only) ○ Engagement and retention of users

Full Information

NCT ID

NCT05205876

First Posted

December 10, 2021

Last Updated

October 2, 2022

Sponsor

Eddii, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05205876

Brief Title

Safety and Feasibility Study of the Eddii Mobile Application

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

January 2, 2021 (Actual)

Primary Completion Date

July 31, 2022 (Actual)

Study Completion Date

August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eddii, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type-1 Diabetes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control (Dexcom app)

Arm Type

No Intervention

Arm Description

This group will use the Dexcom application for management of their blood glucose for the duration of the study (8 weeks).

Arm Title

Intervention (Eddii app)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Eddii mobile application

Intervention Description

Participants will use the Eddii mobile application in the intervention arm.

Primary Outcome Measure Information:

Title

Safety of the Eddii App as assessed by accuracy and reliability of blood glucose measurements

Description

Safety (Intervention Arm only) as assessed by: ○ Functionality and reliability of Eddii application by measuring reported faults

Time Frame

Eight Weeks

Title

Feasibility of the Eddii App as measured by frequency of use

Description

Time Frame

Four Weeks

Secondary Outcome Measure Information:

Title

Change in glycaemic control measured as Time-in-Range (TIR) (70-180mg/dl)

Time Frame

Eight Weeks

Title

QOL (Quality of Life) metrics

Description

- QOL questionnaires conducted mid-study on weeks 2, 4, 6 and 8

Time Frame

Eight Weeks

Title

User Engagement measured through app analytics

Description

App-Specific Measures for Entirety of Study (Intervention Arm only) ○ Engagement and retention of users

Time Frame

Eight Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Farhaneh Ahmadi, PhD

Organizational Affiliation

Eddii, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eddii, inc.

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Safety and Feasibility Study of the Eddii Mobile Application

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