Type-1 DiabetesNCT05205876
Safety and Feasibility Study of the Eddii Mobile Application
A study testing Eddii mobile application in people with Type-1 Diabetes, run by Eddii, Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type-1 Diabetes
- What is being tested?
- Eddii mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Feasibility Study of the Eddii Mobile Application for Glucose Monitoring in Pediatric Patients With Type I Diabetes
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).
Read the 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.
- Conditions
- Type-1 Diabetes
- Being tested
- Eddii mobile application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eddii mobile applicationBehavioural
Participants will use the Eddii mobile application in the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Eddii mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Four Weeks
Secondary outcomes (3)
Change in glycaemic control measured as Time-in-Range (TIR) (70-180mg/dl)
Measured: Eight Weeks
QOL (Quality of Life) metrics
- QOL questionnaires conducted mid-study on weeks 2, 4, 6 and 8
Measured: Eight Weeks
User Engagement measured through app analytics
App-Specific Measures for Entirety of Study (Intervention Arm only)
○ Engagement and retention of users
Measured: Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start2 Jan 2021
- Primary completion31 Jul 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eddii, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Farhaneh Ahmadi, PhD, Principal investigator, Eddii, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205876
- Sponsor's protocol ID
- LeafStudy
- Status last verified
- Oct 2022
- First submitted
- 10 Dec 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Feasibility Study of the Eddii Mobile Application for Glucose Monitoring in Pediatric Patients With Type I Diabetes
- ClinicalTrials.gov ID
- NCT05205876
- Acronym / sponsor ID
- LeafStudy
- Conditions
- Type-1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Eddii, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Eddii mobile applicationThis 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eddii mobile applicationParticipants will use the Eddii mobile application in the intervention arm. | Behavioural | Intervention (Eddii app) |
Primary outcome
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
Feasibility of the Eddii App as measured by frequency of use
Time frame: Four Weeks
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
3 secondary outcomes
Change in glycaemic control measured as Time-in-Range (TIR) (70-180mg/dl)
Time frame: Eight Weeks
QOL (Quality of Life) metrics
Time frame: Eight Weeks
User Engagement measured through app analytics
Time frame: Eight Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhaneh Ahmadi, PhD principal investigator
Eddii, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eddii mobile application in people with Type-1 Diabetes, run by Eddii, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Eddii App as assessed by accuracy and reliability of blood glucose measurements (time frame: Eight Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.