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?

This trial explores better management of blood sugar levels for people with type 1 diabetes during exercise. The goal is to identify the optimal blood sugar target before working out by testing three different levels to determine which best maintains stable blood sugar during and after exercise. Participants should have had type 1 diabetes for at least a year, use a do-it-yourself insulin system, and regularly track their blood sugar with devices like Dexcom. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance exercise management for those with type 1 diabetes.

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.

What prior data suggests that this physical activity trial intervention is safe for people with type 1 diabetes?

A previous study showed that the artificial pancreas system holds promise for safely managing physical activity in people with type 1 diabetes. This system automatically monitors and adjusts insulin levels. Research shows that using this system during exercise is safe. Participants in studies have tolerated it well, with no major side effects reported. The system's ability to detect exercise helps maintain blood sugar levels within a safe range, reducing the risk of low blood sugar during and after exercise. Overall, users have well-received the artificial pancreas system, making it a safe option for those considering joining a trial involving exercise and type 1 diabetes management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different temporary blood glucose targets can optimize exercise management for people with Type 1 Diabetes. Unlike standard care that often relies on fixed glucose thresholds for managing diabetes, this approach tests personalized glucose targets adjusted before physical activity. This could lead to more tailored and effective blood sugar control during exercise, potentially reducing the risk of hypoglycemia and improving overall diabetes management. By experimenting with targets of 8.3, 8.8, and 9.3 mmol/L, researchers hope to find the optimal strategy for balancing exercise benefits with safe glucose levels.

What evidence suggests that this trial's treatments could be effective for managing blood glucose during exercise in type 1 diabetes?

Research shows that artificial pancreas systems can help people with type 1 diabetes exercise safely. These systems use smart technology to maintain steady blood sugar levels. In this trial, participants will join different treatment arms with temporary blood sugar targets set before exercise: 8.3 mmol/L, 8.8 mmol/L, or 9.3 mmol/L. Studies have found that moderate exercise can cause sudden drops in blood sugar, which are difficult to manage. Testing these different targets aims to find the best level to prevent such drops during exercise. Evidence suggests that adjusting targets before exercise can help control blood sugar, making exercise safer and easier for those with type 1 diabetes. ^{1 2 3 6 7}

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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Artificial Pancreas Systems and Physical Activity in Patients ... The artificial pancreas (AP) system is a promising therapeutic option for a safer practice of physical activity in the context of T1D.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7994426/

Anticipation of Historical Exercise Patterns by a Novel ... Objective: Physical activity is a major challenge to glycemic control for people with type 1 diabetes. Moderate-intensity exercise often leads to steep ...

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Study Details | NCT05133765 | The SMART B Exercise Study Despite the established health benefits conveyed by physical activity for people with type 1 diabetes (T1D), participation rates remain low, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05626725

Safety and Effectiveness of Automated Insulin Delivery ... Participants will be required to wear their own artificial pancreas system and give us access to blood glucose and insulin data at the end of the study. They ...

5. academic.oup.com academic.oup.com/jcem/article/108/7/1614/7025366

The Artificial Pancreas and Type 1 Diabetes - Oxford Academic The artificial pancreas or closed-loop system connects these devices via a control algorithm programmed to maintain target glucose.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02862730?term=minimed%20530G&viewType=Table&rank=2

Four Way Crossover Closed Loop With Exercise Detection The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection ...

7. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(23)00112-7/fulltext

Integrating metabolic expenditure information from ... An exercise-aware AID could ultimately help people living with type 1 diabetes improve their overall health through exercise while maintaining ...