Status:
COMPLETED
Safety and Feasibility Study of the Eddii Mobile Application
Lead Sponsor:
Eddii, Inc.
Conditions:
Type-1 Diabetes
Eligibility:
All Genders
5-12 years
Phase:
NA
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 consecut...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05205876
Start Date
January 2 2021
End Date
August 31 2022
Last Update
October 5 2022
Active Locations (1)
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1
Eddii, inc.
New York, New York, United States, 10016