Exercise and Type 1 Diabetes: Chance to Participate in a Large-Scale, Real-World Study
By Eliza Skoler
By Eliza Skoler and Ursula Biba
How might exercise affect your blood glucose? The T1-DEXI study hopes to answer this big question with real-world data from over 600 people with type 1 diabetes – including you! If you have type 1 diabetes and are willing to be active for just 150 minutes each week, this is a unique opportunity to participate remotely in large-scale diabetes research. And, it's quick and easy to sign up!
Last December we wrote about the T1-DEXI trial, which is studying how glucose levels change in people with type 1 diabetes as they exercise. We wrote to the T1-DEXI research team, led by the JAEB Center and supported by The Helmsley Charitable Trust, to update this large-scale, real-world, and entirely virtual trial. In addition, T1-DEXI is still recruiting – you can learn more here.
In this article you’ll read the researchers’ answers to our questions about T1-DEXI.
What is the T1-DEXI study, and why is it important?
Exercise is essential for everyone – and for those living with type 1 diabetes, exercise can reduce chances of developing diabetes-related complications and improve quality of life. However, many people with type 1 diabetes are nervous about exercising because of how it can affect their blood sugar levels; the truth is we don’t know exactly how different types of exercise affect glucose levels during and after activity. The T1-DEXI study aims to answer these questions.
The more we know about how exercise affects glucose levels in people with diabetes, the better they’ll be able to manage their glucose and reduce the hypoglycemia (low blood sugar) and hyperglycemia (elevated blood sugar) that can result from exercise. During exercise, muscles rapidly take glucose from the blood for energy. Right now, many people with type 1 diabetes who exercise consume carbohydrates prior to or during exercise to prevent hypoglycemia – but this may lead to hyperglycemia after exercise and unnecessary weight gain.
The T1-DEXI study aims to include over 600 people, asking them to share day-to-day data over the course of a month. In addition to their regular exercise or physical activity, participants will do six video-based study exercises during the month while wearing a heart rate monitor. Participants will also tag their exercise events in the T1-DEXI app, upload photos of their food on exercise days, and answer quick daily questions. The study hopes to capture real-world information – from people going about their daily lives – so that we can make real-world recommendations.
Is this different from other exercise studies?
Yes! Other studies to date have been clinic-based with prescribed activities, such as 30 minutes of running on a treadmill, usually over the course of just a few days. Most of these studies have been small – 50 people or less. We want to develop real-life recommendations, which is why T1-DEXI is being conducted outside of the lab, in everyday conditions. This will be the first large study to collect data from typical activities outside of a laboratory setting and will track a range of factors that could affect blood sugar levels, including insulin and glucose data, physical activity and stress levels as well as the timing and composition of meals.
What are the study’s main goals?
Develop real-life recommendations to improve diabetes management guidelines so that people with type 1 diabetes can feel confident managing their glucose during exercise – and therefore feel more confident exercising.
Use the information collected to refine decision support tools and algorithms for automated insulin delivery (AID) systems, which can make a huge difference in reducing both hypoglycemia and hyperglycemia.
Share the data publicly under The Helmsley Charitable Trust’s Type 1 Diabetes Data Sharing Initiative. Researchers will be able to use the T1-DEXI data to test their hypotheses, develop new ones, and further knowledge of exercise and diabetes. Diabetes technology companies can use the information to improve their devices and algorithms to meet the needs of people with type 1 diabetes.
How closely do you think the study conditions resemble the ways most people are physically active?
T1-DEXI focuses on collecting data during daily activities, such as household chores, gardening, or participation in sports for leisure or competition. Participants are encouraged to meet a weekly exercise goal of 150 minutes, which includes being active outside of the six study exercises so that we can learn about the effect of normal, day-to-day activities on glucose.
The six structured exercise sessions that participants complete at any time throughout the month will provide data to inform how different types of exercise (aerobic, resistance, high-intensity interval) affect diabetes management. The videos designed for this study include movements typical of an introductory exercise class offered by an athletic trainer. The trainers demonstrate modifications for each exercise to make them accessible to everyone, regardless of current fitness level.
Who can participate in the study?
T1-DEXI is a remote study. We are recruiting across the United States, and we hope the study design makes it easy for people to participate from anywhere and everywhere. Anyone from 18-70 years of age can enroll. We want a study population with different fitness levels, insulin administration methods, and A1C levels.
Interested in participating? T1-DEXI is still actively enrolling – visit the website to sign up. Depending on your level of activity and other screening criteria, you may need to get medical clearance for exercise from a healthcare professional to confirm your eligibility – the study will cover the cost of this medical clearance.
Additional eligibility criteria:
Diagnosed with type 1 diabetes for at least two years.
Not using a DIY, non-FDA approved closed loop system.
Some pre-existing medical conditions and medications could make the exercise program risky, and will disqualify potential participants.
Have had a recent eye exam, usually within the last 12 months.
Not taking an SGLT-2 or GLP-1 medication.
What should people expect to do while participating in the one-month study?
Complete the 30-minute study exercise video at least six times.
Be active for at least 150 minutes (2.5 hours) each week.
Wear an activity recorder on their wrist for the month of the study. During the study exercises, participants also wear a chest strap to measure heart rate.
Use the T1-DEXI mobile application to capture information on exercise, activity, food intake, and insulin dosing (for injections not captured by Biocorp’s Mallya smart pen).
Participants who do not use CGM will wear a blinded CGM for the duration of the study – they’ll be able to access their data after the study.
How will the results of this study promote access to CGM and quality care for people with diabetes?
CGM is an effective tool for preventing hypoglycemia, and we expect that over time it will become more accessible with lower prices and more insurance coverage. However, the findings of this study may also help people who are not using CGM. We hope to be better able to predict glucose changes, rather than measuring glucose and responding to the changes during exercise. For example, a person who uses a blood glucose meter to check their glucose levels may find value in knowing their likelihood of hypoglycemia during a certain type of exercise performed at a certain time of day, at a certain intensity, and for a certain duration, even if they cannot observe the outcome on their own CGM. We plan to learn a lot about active behavior in people with type 1 diabetes that is applicable to everyone, regardless of their glucose monitoring approach.