Decision Support Tool for Type 1 Diabetes

(NEXT Trial)

Overseen By Dessi Zaharieva, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: Insulin

Must not be taking: Steroids, SGLT-2 inhibitors

Disqualifiers: Severe hypoglycemia, Unstable cardiopulmonary, Pregnancy, Renal insufficiency, Coronary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool designed to help individuals with type 1 diabetes manage blood sugar levels when preparing for exercise. Participants will try different methods: standard guidelines, their usual routine, and the new tool, the netIOB & Exercise Toolkit (NEXT), which provides personalized advice on food and insulin adjustments. The goal is to determine which method maintains stable and safe blood sugar levels during exercise. This trial may suit individuals who have had type 1 diabetes for over a year and can walk briskly for an hour without issues. As an unphased trial, it offers a unique opportunity to explore innovative solutions for managing diabetes during exercise.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop your current medications, but you must be on a stable insulin regimen and cannot use certain other medications that affect blood sugar unless they are stable with no planned changes. If you're taking medications like systemic steroids, you need to have stopped them at least 4 weeks before the study.

What prior data suggests that this digital decision-support tool is safe for individuals with type 1 diabetes?

Research has shown that the NEXT tool helps people with type 1 diabetes manage their exercise routines by providing personalized advice based on blood sugar levels and insulin use. Although specific safety data for the NEXT tool is not available, it is generally considered safe as a digital tool. The trial phase is marked as "Not Applicable," indicating that the tool is neither a drug nor a surgical treatment, thus posing minimal risk to participants. By focusing on advice rather than directly altering treatment, the tool presents a lower chance of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the netIOB & Exercise Toolkit (NEXT) because it offers a personalized approach to managing Type 1 Diabetes around exercise. Unlike the current standard-of-care that relies on general guidelines for insulin and carbohydrate adjustments, NEXT uses real-time data from continuous glucose monitors (CGM), insulin history, and immediate inputs to generate tailored recommendations. This algorithm-driven method allows for more precise adjustments, potentially improving blood sugar control and reducing the risk of exercise-induced hypoglycemia.

What evidence suggests that the NEXT tool is effective for exercise preparation in type 1 diabetes?

Research has shown that the netIOB & Exercise Toolkit (NEXT), which participants in this trial may receive, can help people with type 1 diabetes manage blood sugar levels during exercise. One study found that the number of low blood sugar episodes dropped from 0.1 to 0 per week, and high blood sugar episodes also decreased significantly. This tool uses data from continuous glucose monitors and past insulin use to provide personalized advice, such as how much to eat or when to adjust insulin before exercising. These early results are promising for better blood sugar control during physical activity. ^{1 2 4 5 6}

Who Is on the Research Team?

Dessi [e-mail], PhD

Principal Investigator

Stanford University

Rayhan Lal, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with type 1 diabetes who are interested in managing exercise better. Participants should be willing to complete three structured exercise sessions under different guidance approaches, including using a digital decision-support tool.

Inclusion Criteria

I am between 18 and 60 years old.

I have been using Tandem Control-IQ and Dexcom G7 for at least 1 month.

I can walk at a moderate pace for 60 minutes without difficulty.

Exclusion Criteria

Concurrent participation in another interventional drug/device study within 30 days

Inability to comply with study procedures or safety requirements (e.g., cannot achieve target HR zone, cannot attend visits, or cannot enable device data access), or otherwise deemed unsuitable by the investigator

Intercurrent illness or medical conditions that preclude safe participation in moderate-intensity exercise (e.g. unstable cardiopulmonary disease, uncontrolled arrhythmia, or uncontrolled hypertension), as previously assessed by the individual's primary care physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Sessions

Participants complete three structured aerobic or mixed-exercise sessions using different guidance approaches

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after exercise sessions

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• netIOB & Exercise Toolkit (NEXT)

Trial Overview The study tests the netIOB & Exercise Toolkit (NEXT), which gives personalized advice on preparing for exercise based on glucose data and insulin history. It's compared against standard-of-care guidelines and participants' usual routines during aerobic or mixed-exercise sessions.

How Is the Trial Designed?

Group I: netIOB & Exercise Toolkit (NEXT) Experimental Treatment 1 Intervention

Physicians receive personalized, algorithm-informed recommendations for exercise-related insulin and carbohydrate adjustments. Recommendations are generated using the investigational netIOB \& Exercise Toolkit based on CGM data, insulin history, and real-time inputs.

Group II: Usual Care (UC) Experimental Treatment 1 Intervention

Participants use their own strategies for managing insulin and carbohydrate around exercise.

Group III: Standard-of-Care (SoC) Experimental Treatment 1 Intervention

Participants follow consensus-based guidance for insulin and carbohydrate adjustments around exercise, as outlined in current international standards. These recommendations are applied by study staff in advance of the exercise session.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

University College Dublin

Collaborator

Trials

163

Recruited

130,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226583

Using a Personalized Decision Support Tool to Help ... This study evaluates a digital decision-support tool designed to help individuals with type 1 diabetes prepare for exercise. This netIOB ...

2. next.dev.ceadar.org next.dev.ceadar.org/

NEXT | NetIOB and Exercise Toolkit for Type 1 Diabetes We're laying the foundation for a future pilot study to test the impact of netIOB & customized predictions on glucose outcomes across a range of exercise ...

3. researchgate.net researchgate.net/publication/383145251_Refining_Insulin_on_Board_with_netIOB_for_Automated_Insulin_Delivery

Refining Insulin on Board with netIOB for Automated ... Results Median (interquartile range) Ehypo (<70 mg/dL) events/week decreased from 0.1 (0-0.4) to 0 (0-0.1) and Ehyper (>250 mg/dL) events/week decreased from ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571556/

Refining Insulin on Board with netIOB for Automated ... A brief review on the evolution of technology in exercise and sport in type 1 diabetes: past, present, and future. Diabetes Technol Ther.

5. discover.academics.yorku.ca discover.academics.yorku.ca/MichaelC.Riddell/publications

Michael C Riddell | Publications | Discover York Academics The effect of several pre-exercise factors on the within-participant glycemic variability was evaluated. RESULTS: Data from 476 adults with type 1 diabetes were ...

6. meddatax.com meddatax.com/clinical-trials/NCT07226583

Using a Personalized Decision Support Tool to Help People ... This study evaluates a digital decision-support tool designed to help individuals with type 1 diabetes prepare for exercise. This netIOB ...