Type 2 DiabetesNCT06501612
Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7
A study testing Continuous Glucose Monitor and Undermyfork App and Continuous Glucose Monitor in people with Type 2 Diabetes, run by Scripps Whittier Diabetes Institute at 1 site in United States.
Trial summary
This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits, contributing to our understanding of the potential advantages and informing future diabetes care practices. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Continuous Glucose Monitor and Undermyfork App and Continuous Glucose Monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2024to 5 Dec 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with type 2 diabetes
- Are on any pills or injectable glucose lowering medication regimen except bolus insulin
- Speak, read, and write in English
- Have A1c between 7.7% and 12.5% in the last 90 days
- Have a cell phone that can download the Dexcom G7 and Undermyfork app
Who cannot join
- Are on bolus insulin
- Are pregnant
- Are currently participating in another diabetes related study
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
About this study
Official title: Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7 in a Real-World Community Ambulatory Health Setting
This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits, contributing to our understanding of the potential advantages and informing future diabetes care practices. The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications. Unlike standard care, which often involves periodic fingerstick glucose testing and limited dietary guidance, the proposed intervention offers continuous monitoring and tailored dietary insights, thus potentially improving overall diabetes management outcomes. The proposed intervention, therefore, deviates from standard care by integrating mobile health apps into the routine for CGM use, offering a novel avenue for enhanced glycemic monitoring and management.
Read the detailed description
The current research study seeks to determine the feasibility, acceptability, and effectiveness of using continuous glucose monitors (CGM) with and without a digital food diary (Undermyfork) for CGM naïve individuals with type 2 diabetes (T2D) in a real-world large community health setting. Undermyfork, as a novel digital tool, integrates CGM data with meal tracking, offering users insights into their dietary choices and glucose levels. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In addition, while the number of free health-related mobile applications continues to increase and underscores the growing interest in leveraging technology to improve health outcomes, there is a limited number of apps that are grounded in evidence. This highlights the importance for clinical testing to evaluate the efficiency and practicality of mobile apps aimed at enhancing health behaviors and outcomes, particularly with diabetes.
This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits, contributing to our understanding of the potential advantages and informing future diabetes care practices. The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications. Unlike standard care, which often involves periodic fingerstick glucose testing and limited dietary guidance, the proposed intervention offers continuous monitoring and tailored dietary insights, thus potentially improving overall diabetes management outcomes.
This need for new and effective treatments for T2D motivates the exploration of interventions like the proposed study to integrate easy-to-access mobile technology with CGM. Despite the availability of various diabetes management strategies, optimizing glycemic control remains a challenge. By evaluating the clinical and financial benefits of adding a mobile self-management apps to CGM technology, this study contributes to addressing the unmet needs of individuals who are interested in taking an active role in their health, aiming to advance our understanding of effective and patient-centered diabetes care. The potential outcomes of this research can influence future practices in diabetes management, benefiting individuals with T2D and contributing to the broader landscape of diabetes care.
- Conditions
- Type 2 Diabetes
- Being tested
- Continuous Glucose Monitor and Undermyfork App, Continuous Glucose Monitor
- Keywords
- Diabetes Technology, Diabetes Mobile Application, CGM Monitor
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor and Undermyfork AppOther
Participants will be provided two Dexcom G7 sensors to wear during the 20-day intervention period (two 10-day devices). Participants will also be instructed to download and use Undermyfork mobile application where they will have access to their history of their blood glucose responses to their meals in Undermyfork. A randomly selected number of participants in this group will be requested to complete a semi-structured qualitative interview to assess satisfaction with using Undermyfork application immediately following the intervention.
Continuous Glucose MonitorOther
Participants will be provided two Dexcom G7 sensors to wear during the 20-day intervention period (two 10-day devices).
| Study group | Role | What they receive |
|---|---|---|
| CGM plus Undermyfork group | Experimental | Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 2 devices) and will be instructed to use the mobile food diary application. A post-Undermyfork satisfaction qualitative interview will be administered and compensation provided when the CGM is removed and survey completed. Receives: Other: Continuous Glucose Monitor and Undermyfork App |
| CGM Only group | Active comparator | Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 2 devices). Receives: Other: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Blood Glucose Level as Measured by HbA1c at Baseline, Day 20, and 4 Months
HbA1c is a person's average blood glucose level over the past three months. This measurement will be collected using lab results provided from healthcare provider. Scores below 7% indicate a healthy HbA1c. Scores above 7% indicate increased risk of diabetes-related complications.
Measured: 4 months
Secondary outcomes (7)
Time in Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent in Target Range at Day 20
Measures the percentage of time a participant's blood glucose levels stay within the target range using a CGM device throughout the 20-day intervention. Target range is defined as having a blood glucose level between 70 and 180 mg/dL. Thus, percent Time in Range = 100 (Number readings in range (70-180mg/dL)/Total number of readings from CGM). Number of readings will be used in calculation, which scale directly with time.
Measured: 20 days
Time Above Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Above Target Range at Day 20
Measures the percentage of time a participant's blood glucose levels exceed the target range using a CGM device throughout the 20-day intervention. Above range is defined as having a blood glucose level above 180 mg/dL. Thus, percent Time Above Range = 100 (Number readings above range (>140mg/dL)/Total number of readings from CGM). Number of readings will be used in calculation, which scale directly with time.
Measured: 20 days
Time Below Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Below Target Range at Day 20
Measures the percentage of time a participant's blood glucose levels fall below the target range (usually less than 70 mg/dL) using a CGM device throughout the 20-day intervention. Below range is defined as having a blood glucose level below 70 mg/dL. Thus, percent Time Below Range = 100 (Number readings below range (<70mg/dL)/Total number of readings from CGM). Number of readings will be used in calculation, which scale directly with time.
Measured: 20 days
Frequency of Compliance with Diabetes Self-Care Activities as Measured by the Summary of Diabetes Self Care Activities (SDSCA) Survey at Baseline, Day 20, and 4 Months
The Summary of Diabetes Self Care Activities Survey measures frequency and consistency of diabetes self-care activities during the past 7 days. Possible scores range from 0 (0 Days) to 7 (7 Days). Higher scores indicate better compliance with diabetes self-care.
Measured: 4 months
Severity of Diabetes Distress as Measured by the T2-Diabetes Distress Assessment System, Core Subscale at Baseline, Day 20, and 4 Months
The T2-Diabetes Distress Assessment System, Core Subscale produces a total score to reflect overall emotional distress related to diabetes for individuals with type 2 diabetes. Possible scores range from 1 (Not a Problem) to 5 (A Very Serious Problem) with higher scores indicating higher reported levels of diabetes-related distress.
Measured: 4 months
Severity of Social Determinants of Health as Measured by the Scripps Social Determinants of Health Screening Tool at Baseline, Day 20, and 4 Months
The Social Determinants of Health (SDOH) Screening tool measures the environmental conditions where people are born, live, learn, work, and age that affect a wide range of health and quality-of-life outcomes using 12 items. Possible responses include: Yes, No, Decline to Answer, or Unable to Assess. More "yes" responses indicate more severe environmental conditions affecting health.
Measured: 4 months
Comfortability with Using Mobile Applications as a Health Resource as Measured by Two Likert-type Items at 4 Months
The 2 brief items of this measure examine participants' comfort and perceived skills at using mobile health applications for their health on a scale ranging from (1) not comfortable to (5) very comfortable. Higher scores indicate that participant is more comfortable with using mobile health applications as a health resource. This helps identifying patients with adequate mobile health technology literacy.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start9 Oct 2024
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athena Philis-Tsimikas, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501612
- Sponsor's protocol ID
- 24-8369
- Status last verified
- Mar 2026
- First submitted
- 9 Jul 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown K, Ushakov M, Molodkin E, Spierling Bagsic SR, Bell C, Philis-Tsimikas A. Evaluating clinical outcomes of using Undermyfork mobile app with Dexcom G7: Protocol for CGM-Undermyfork randomized controlled trial. Contemp Clin Trials. 2026 Aug;167:108386. doi: 10.1016/j.cct.2026.108386. Epub 2026 Jun 23.
PubMed 42336271
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7 in a Real-World Community Ambulatory Health Setting
- ClinicalTrials.gov ID
- NCT06501612
- Acronym / sponsor ID
- 24-8369
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Technology, Diabetes Mobile Application, CGM Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 15 Jul 2024 (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.
This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits, contributing to our understanding of the potential advantages and informing future diabetes care practices. The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications. Unlike standard care, which often involves periodic fingerstick glucose testing and limited dietary guidance, the proposed intervention offers continuous monitoring and tailored dietary insights, thus potentially improving overall diabetes management outcomes. The proposed intervention, therefore, deviates from standard care by integrating mobile health apps into the routine for CGM use, offering a novel avenue for enhanced glycemic monitoring and management.
Detailed description
The current research study seeks to determine the feasibility, acceptability, and effectiveness of using continuous glucose monitors (CGM) with and without a digital food diary (Undermyfork) for CGM naïve individuals with type 2 diabetes (T2D) in a real-world large community health setting. Undermyfork, as a novel digital tool, integrates CGM data with meal tracking, offering users insights into their dietary choices and glucose levels. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In addition, while the number of free health-related mobile applications continues to increase and underscores the growing interest in leveraging technology to improve health outcomes, there is a limited number of apps that are grounded in evidence. This highlights the importance for clinical testing to evaluate the efficiency and practicality of mobile apps aimed at enhancing health behaviors and outcomes, particularly with diabetes.
This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits, contributing to our understanding of the potential advantages and informing future diabetes care practices. The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications. Unlike standard care, which often involves periodic fingerstick glucose testing and limited dietary guidance, the proposed intervention offers continuous monitoring and tailored dietary insights, thus potentially improving overall diabetes management outcomes.
This need for new and effective treatments for T2D motivates the exploration of interventions like the proposed study to integrate easy-to-access mobile technology with CGM. Despite the availability of various diabetes management strategies, optimizing glycemic control remains a challenge. By evaluating the clinical and financial benefits of adding a mobile self-management apps to CGM technology, this study contributes to addressing the unmet needs of individuals who are interested in taking an active role in their health, aiming to advance our understanding of effective and patient-centered diabetes care. The potential outcomes of this research can influence future practices in diabetes management, benefiting individuals with T2D and contributing to the broader landscape of diabetes care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM plus Undermyfork group | Experimental | Other: Continuous Glucose Monitor and Undermyfork AppParticipants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 2 devices) and will be instructed to use the mobile food diary application. A post-Undermyfork satisfaction qualitative interview will be administered and compensation provided when the CGM is removed and survey completed. |
| CGM Only group | Active comparator | Other: Continuous Glucose MonitorParticipants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 2 devices). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been diagnosed with type 2 diabetes
- Are on any pills or injectable glucose lowering medication regimen except bolus insulin
- Speak, read, and write in English
- Have A1c between 7.7% and 12.5% in the last 90 days
- Have a cell phone that can download the Dexcom G7 and Undermyfork app
Key exclusion criteria (3 listed)
- Are on bolus insulin
- Are pregnant
- Are currently participating in another diabetes related study
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 |
|---|---|---|
| Continuous Glucose Monitor and Undermyfork AppParticipants will be provided two Dexcom G7 sensors to wear during the 20-day intervention period (two 10-day devices). Participants will also be instructed to download and use Undermyfork mobile application where they will have access to their history of their blood glucose responses to their meals in Undermyfork. A randomly selected number of participants in this group will be requested to complete a semi-structured qualitative interview to assess satisfaction with using Undermyfork application immediately following the intervention. | Other | CGM plus Undermyfork group |
| Continuous Glucose MonitorParticipants will be provided two Dexcom G7 sensors to wear during the 20-day intervention period (two 10-day devices). | Other | CGM Only group |
Primary outcome
Average Blood Glucose Level as Measured by HbA1c at Baseline, Day 20, and 4 Months
Time frame: 4 months
HbA1c is a person's average blood glucose level over the past three months. This measurement will be collected using lab results provided from healthcare provider. Scores below 7% indicate a healthy HbA1c. Scores above 7% indicate increased risk of diabetes-related complications.
7 secondary outcomes
Time in Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent in Target Range at Day 20
Time frame: 20 days
Time Above Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Above Target Range at Day 20
Time frame: 20 days
Time Below Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Below Target Range at Day 20
Time frame: 20 days
Frequency of Compliance with Diabetes Self-Care Activities as Measured by the Summary of Diabetes Self Care Activities (SDSCA) Survey at Baseline, Day 20, and 4 Months
Time frame: 4 months
Severity of Diabetes Distress as Measured by the T2-Diabetes Distress Assessment System, Core Subscale at Baseline, Day 20, and 4 Months
Time frame: 4 months
Severity of Social Determinants of Health as Measured by the Scripps Social Determinants of Health Screening Tool at Baseline, Day 20, and 4 Months
Time frame: 4 months
Comfortability with Using Mobile Applications as a Health Resource as Measured by Two Likert-type Items at 4 Months
Time frame: 4 months
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 6 Mar 2026.
- Derived from this study: PubMed 42336271Brown K, Ushakov M, Molodkin E, Spierling Bagsic SR, Bell C, Philis-Tsimikas A. Evaluating clinical outcomes of using Undermyfork mobile app with Dexcom G7: Protocol for CGM-Undermyfork randomized controlled trial. Contemp Clin Trials. 2026 Aug;167:108386. doi: 10.1016/j.cct.2026.108386. Epub 2026 Jun 23.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Athena Philis-Tsimikas, MD principal investigator
Scripps Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor and Undermyfork App and Continuous Glucose Monitor in people with Type 2 Diabetes, run by Scripps Whittier Diabetes Institute 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 5 inclusion and 3 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 6 Mar 2026. 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?
Average Blood Glucose Level as Measured by HbA1c at Baseline, Day 20, and 4 Months (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06501612, which also lists 1 linked publication.
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 6 Mar 2026.