90 Participants Needed

Undermyfork App + CGM for Type 2 Diabetes

KB
AP
KB
Overseen ByKallie Brown, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Scripps Whittier Diabetes Institute
Must be taking: Glucose lowering
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a mobile app called Undermyfork, used with a continuous glucose monitor (CGM), can help people with Type 2 diabetes better manage their blood sugar and reduce complications. Participants will use either the CGM alone or both the CGM and the app, which tracks diet and provides personalized insights. The trial targets individuals with Type 2 diabetes who take medication (excluding bolus insulin), have an A1c between 7.7% and 12.5%, and possess a smartphone for app use. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage diabetes through technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are not on bolus insulin. You can continue with other glucose-lowering medications.

What prior data suggests that this app and device combination is safe for managing Type 2 Diabetes?

Research shows that people with Type 2 Diabetes generally receive the Undermyfork mobile app well when used with the Dexcom G7 continuous glucose monitor (CGM). This combination helps users track blood sugar levels and understand how meals affect glucose. Although specific safety details aren't provided, the FDA has approved the Dexcom G7 for glucose monitoring, indicating a safety review. The app primarily assists with logging meals and tracking glucose, activities that typically don't raise safety concerns. Overall, both the app and the monitor have been used without major reports of problems, making them a promising option for managing diabetes.12345

Why are researchers excited about this trial?

Researchers are excited about the Undermyfork app combined with the Dexcom G7 CGM because it offers a new way to manage Type 2 Diabetes by integrating technology into daily care. Unlike traditional methods that rely on manual glucose monitoring and food tracking, this approach uses the Dexcom G7 for continuous glucose monitoring and the Undermyfork app for easy, digital food diary maintenance. This combination could provide real-time insights into how food choices directly affect blood sugar levels, potentially leading to more personalized and effective diabetes management. By making it easier to see and understand the impact of diet on glucose levels, researchers hope this method will empower patients to make better-informed decisions about their health.

What evidence suggests that using the Undermyfork app with CGM is effective for managing Type 2 Diabetes?

In this trial, participants in the CGM plus Undermyfork group will use the Undermyfork app with a Dexcom G7 continuous glucose monitor (CGM) to manage type 2 diabetes more effectively. Research has shown that the app provides personalized advice on food choices by analyzing how different meals affect blood sugar levels. This information helps users make better food decisions, potentially improving overall diabetes management. By combining real-time blood sugar monitoring with customized dietary advice, users may achieve better blood sugar control and lower the risk of complications. Many users have reported that this method helps maintain blood sugar within a healthy range after eating.23467

Who Is on the Research Team?

AP

Athena Philis-Tsimikas, MD

Principal Investigator

Scripps Health

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who haven't used a Continuous Glucose Monitor (CGM) in the last 6 months, have an HbA1c level between 7.7% and 12.5%, use a smartphone regularly, and are on stable glucose-lowering medication except bolus insulin.

Inclusion Criteria

My HbA1c level is between 7.7% and 12.5%.
I haven't used a CGM device in the last 6 months.
I use a smartphone regularly and can download apps.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use continuous glucose monitors (Dexcom G7) with or without the Undermyfork mobile app for real-time glucose monitoring and dietary tracking

20 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of diabetes distress and self-care activities

4 months
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Undermyfork Mobile App with Dexcom G7
Trial Overview The study tests if using the Undermyfork mobile app alongside a Dexcom G7 CGM device improves diabetes management compared to just using the CGM alone. It evaluates how real-time monitoring combined with dietary tracking affects glycemic control.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: CGM plus Undermyfork groupExperimental Treatment1 Intervention
Group II: CGM Only groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials
19
Recruited
5,400+

Citations

Pilot RCT Evaluating Clinical Outcomes of Using ...This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits.
UndermyforkUndermyfork insights can help users understand how specific meals impact blood glucose levels and help inform future food decisions.
Undermyfork App + CGM for Type 2 DiabetesTrial Overview The study tests if using the Undermyfork mobile app alongside a Dexcom G7 CGM device improves diabetes management compared to just using the CGM ...
4.undermyfork.comundermyfork.com/
UndermyforkUndermyfork automatically combines glucose data from your CGM, FGM, or BGM with the meal pictures and calculates postprandial Time in Range for each meal.
Acceptability & Impact of a Diabetes Management Smartphone App ...Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7 ... The Effectiveness of Using a Mobile Application for Type 2 Diabetes ...
Pilot RCT Evaluating Clinical Outcomes of Using ...Clinical trial for Type 2 Diabetes , Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7.
Undermyfork: Diabetes appUndermyfork is a simple food diary with glucose trends for people with diabetes. Take pictures of your meals and discover how your choices of food, insulin ...
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