Exercise Blood Glucose Management for Type 1 Diabetes

(GUARDIA Trial)

Overseen By Roxane St-Amand, Mec

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institut de Recherches Cliniques de Montreal

Must be taking: Rapid insulin

Disqualifiers: Severe hypoglycemia, Ketoacidosis, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 3

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Despite major technological advances in type 1 diabetes (artificial pancreas), the management of hypoglycemia remains a major challenge, especially during and after physical activity. The primary outcome is to determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in people with type 1 diabetes (PWT1D) using do-it-yourself automated insulin delivery (DIY-AID) systems. Three glycemic thresholds to be applied 60 minutes before physical activity will be tested in 32 people on AID-DIY: 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L. Each participant will perform 3 sessions of moderate aerobic physical activity (ergocycle) at 60% of vo2peak with a different glycemic target each time (random order). Plasma glucose will be measured every 20 minutes before and during physical activity, and blood glucose measured by continuous glucose reading (DEXCOM) for 24 hours post-intervention. Once the best glycemic target is selected, participants could come to the research center for 1 or 2 more voluntary interventions to test the threshold during 1) fasting exercise and 2) late luteal phase of the menstrual cycle.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does require participants to use specific insulin types and a continuous glucose monitor, so you may need to adjust your current diabetes management tools.

Is exercise blood glucose management for type 1 diabetes safe for humans?

Research on using an artificial pancreas system during exercise for people with type 1 diabetes shows it can help manage blood sugar levels safely. Studies have tested heart rate monitors and other devices to improve safety and reduce the risk of low blood sugar during exercise. ^{1 2 3 4 5}

How is the Physical Activity Trial Intervention for Type 1 Diabetes different from other treatments?

This treatment is unique because it uses a multivariable adaptive artificial pancreas (a device that automatically adjusts insulin levels) to manage blood sugar during exercise, which is challenging for people with type 1 diabetes. It incorporates continuous glucose monitoring and heart rate data to enhance control, especially during and after exercise, unlike traditional methods that don't adjust for exercise-related changes. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Physical activity trial intervention, Physical Activity Trial Intervention, Artificial Pancreas Management for managing blood glucose in type 1 diabetes?

Research shows that using an artificial pancreas system, especially when informed by heart rate during exercise, can improve blood sugar control in people with type 1 diabetes. Additionally, incorporating physical activity into the management plan can enhance the effectiveness of these systems. ^{1 3 6 9 10}

Who Is on the Research Team?

Remi Rabasa-Lhoret, MD, PhD

Principal Investigator

IRCM

Are You a Good Fit for This Trial?

Adults aged 18-65 with Type 1 Diabetes using a DIY automated insulin delivery system for at least 3 months, an HbA1c below 8.5%, and on rapid or ultra-rapid acting insulin can join. They must own a smartphone/tablet and use specific apps to share data. Pregnant/breastfeeding individuals, those with recent major diabetes complications or physical activity restrictions due to severe diabetes-related issues are excluded.

Inclusion Criteria

Using Dexcom G6 and willing to share CGM data with the research team

I use fast-acting insulin.

I have been using the DIY-AID system for 3 months.

Exclusion Criteria

My blood pressure is not higher than 150/95 mmHg.

Ongoing pregnancy or breastfeeding

I have physical activity restrictions due to severe diabetes complications or other health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo three sessions of moderate aerobic physical activity with different glycemic targets

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after each intervention session

24 hours post-exercise

Optional Extension

Participants may opt for additional interventions during fasting exercise and the late luteal phase of the menstrual cycle

What Are the Treatments Tested in This Trial?

Interventions

• Physical activity trial intervention

Trial Overview The trial is testing three different blood glucose targets set before exercise in people with Type 1 Diabetes using artificial pancreas systems. Participants will do aerobic exercises under each target condition to find the best one for managing hypoglycemia during/after physical activity.

How Is the Trial Designed?

Group I: Temporary target of 9.3 mmol/L Experimental Treatment 1 Intervention

Temporary target set 60 minutes before the intervention

Group II: Temporary target of 8.8 mmol/L Experimental Treatment 1 Intervention

Temporary target set 60 minutes before the intervention

Group III: Temporary target of 8.3 mmol/L Active Control 1 Intervention

Current commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention.

Who Is Running the Clinical Trial?

Institut de Recherches Cliniques de Montreal

Lead Sponsor

Trials

72

Recruited

10,300+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Published Research Related to This Trial

The multivariable adaptive artificial pancreas (MAAP) effectively maintained glucose concentrations within the euglycemic range (70-180 mg/dL) for 69.9% of the time during exercise and recovery in 18 closed-loop experiments involving 96 exercise sessions.

Hypoglycemic events were minimal, occurring in only 14.6% of exercise sessions and representing just 2.22% of the total exercise and recovery period, indicating that MAAP can help safely manage glucose levels during different types of physical activity for individuals with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multivariable Artificial Pancreas for Various Exercise Types and Intensities. Turksoy, K., Hajizadeh, I., Hobbs, N., et al.[2019]

A systematic review of 11 studies involving youth with type 1 diabetes found that physical activity interventions significantly reduced hemoglobin A1c (HbA1c) levels, indicating improved glycemic control, with a weighted mean difference of -0.85%.

Most interventions focused on increasing physical activity and fitness, with eight out of eleven showing positive effects on health, but there was a lack of theory-based and supervised programs, highlighting a gap in effective behavior change strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of physical activity and sedentary behavior intervention studies in youth with type 1 diabetes: study characteristics, intervention design, and efficacy. MacMillan, F., Kirk, A., Mutrie, N., et al.[2022]

Accelerometers (AU) provide a more reliable and consistent measure of physical activity in patients with type 1 diabetes compared to heart rate (HR) monitors, showing less variability between individuals.

Using AU to quantify physical activity can enhance the effectiveness of an artificial endocrine pancreas (AEP) by providing clearer insights into activity levels, which is crucial for managing insulin administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of physical activity sensors and heart rate monitoring for real-time activity detection in type 1 diabetes and control subjects. Manohar, C., O'Keeffe, DT., Hinshaw, L., et al.[2022]

Integrating a heart rate monitor with an artificial pancreas system improved blood glucose control during exercise for adolescents with type 1 diabetes, resulting in significantly less time spent below 70 mg/dL compared to the standard system.

While the heart rate monitor did not significantly reduce the total number of hypoglycemic events, it helped maintain blood glucose levels within the target range more effectively during exercise, indicating a potential benefit for managing diabetes in active adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart rate informed artificial pancreas system enhances glycemic control during exercise in adolescents with T1D. DeBoer, MD., Cherñavvsky, DR., Topchyan, K., et al.[2022]

The development of an external artificial pancreas (AP) for type 1 diabetes is expected to evolve gradually, starting with basic functions and advancing to more complex features that account for varying exercise intensities.

Current research often focuses on moderate exercise, neglecting the effects of intense exercise on glucose levels; continuous glucose monitoring combined with frequent blood glucose measurements is essential for understanding these effects and improving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense exercise in type 1 diabetes: exploring the role of continuous glucose monitoring. Chassin, LJ., Wilinska, ME., Hovorka, R.[2021]

In a study involving 17 adults with type 1 diabetes, the dual-hormone artificial pancreas (insulin and glucagon) significantly reduced the time spent at low glucose levels (<4.0 mmol/l) compared to the single-hormone system (0% vs 11%; p=0.0001), indicating better glucose regulation during exercise.

The dual-hormone system also showed a trend towards fewer instances of exercise-induced hypoglycemia during interval exercise (6.25% vs 40% in single-hormone), suggesting it may be safer during high-intensity activities, with no reported side effects in any intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. Taleb, N., Emami, A., Suppere, C., et al.[2022]

Regular physical activity can provide significant health benefits for individuals with type 1 diabetes, but it also complicates blood glucose control due to various factors like activity type and insulin levels.

An 'exercise smart' artificial pancreas that can sense glucose and physiological responses during different types of physical activity may help manage blood sugar levels more effectively, reducing the risk of hypo and hyperglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and the Development of the Artificial Pancreas: One of the More Difficult Series of Hurdles. Riddell, MC., Zaharieva, DP., Yavelberg, L., et al.[2018]

In a study involving 22 participants with type 1 diabetes, an augmented predictive low glucose suspend (PLGS) algorithm that incorporated data from a combined accelerometer and heart rate monitor (HRM) significantly reduced exercise-related hypoglycemia by 76%, compared to a 62% reduction with the standard PLGS algorithm.

The results indicated that while the accelerometer-augmented algorithm was effective, the addition of the HRM did not provide additional benefits, suggesting that using just the accelerometer is sufficient for improving hypoglycemia management during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Accelerometer and Heart Rate Data on Hypoglycemia Mitigation in Type 1 Diabetes. Stenerson, M., Cameron, F., Wilson, DM., et al.[2021]

In a study involving 21 adults with type 1 diabetes, using a dual-hormone artificial pancreas (APX) that adjusts insulin and glucagon during exercise significantly reduced the time spent in hypoglycaemia (0.3%) compared to no adjustment (3.1%).

The dual-hormone system (APX) performed similarly to sensor-augmented pump therapy (SAP) in maintaining euglycaemia, indicating that real-time adjustments to hormone delivery can effectively manage blood sugar levels during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy. Jacobs, PG., El Youssef, J., Reddy, R., et al.[2022]

Continuous glucose monitoring (CGM) has significantly enhanced the understanding of how exercise affects blood sugar levels in adults with type 1 diabetes (T1D), particularly during the late post-exercise period, which was previously difficult to study.

The accuracy of CGM sensors is deemed sufficient for exercise monitoring, making them essential for developing advanced diabetes management systems like closed-loop and artificial pancreas systems, while also helping T1D patients manage their glucose levels effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring and Exercise in Type 1 Diabetes: Past, Present and Future. Houlder, SK., Yardley, JE.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Multivariable Artificial Pancreas for Various Exercise Types and Intensities. [2019]

2. Denmark pubmed.ncbi.nlm.nih.gov

A systematic review of physical activity and sedentary behavior intervention studies in youth with type 1 diabetes: study characteristics, intervention design, and efficacy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of physical activity sensors and heart rate monitoring for real-time activity detection in type 1 diabetes and control subjects. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

Heart rate informed artificial pancreas system enhances glycemic control during exercise in adolescents with T1D. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intense exercise in type 1 diabetes: exploring the role of continuous glucose monitoring. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Exercise and the Development of the Artificial Pancreas: One of the More Difficult Series of Hurdles. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The Impact of Accelerometer and Heart Rate Data on Hypoglycemia Mitigation in Type 1 Diabetes. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring and Exercise in Type 1 Diabetes: Past, Present and Future. [2018]