Safety and Feasibility Study of the Eddii Mobile Application

NCT05205876 | Completed DMC

• 1 other identifier: LeafStudy
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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).

Conditions

Type-1 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

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

  Eight Weeks

• QOL (Quality of Life) metrics

  Eight Weeks

• User Engagement measured through app analytics

  Eight Weeks

Study Arms (2)

Control (Dexcom app)

NO INTERVENTION

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

Intervention (Eddii app)

EXPERIMENTAL

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.

Behavioral: Eddii mobile application

Interventions

Eddii mobile application BEHAVIORAL

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

Intervention (Eddii app)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 is willing to be responsible for management of the Eddii mobile application use
• Volunteer must have and use an iOS smart phone device

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eddii, Inc.: lead

Study Sites (1)

Eddii, inc.

New York, New York, 10016, United States

Location

Study Officials

• Farhaneh Ahmadi, PhD

  Eddii, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 25, 2022
• Study Start: January 2, 2021
• Primary Completion: July 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)