Physical Activity for Type 1 Diabetes

(Missed Dose Trial)

Overseen By Jane Yardley, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Jane Yardley

Must be taking: Insulin

Must not be taking: SGLT2-inhibitors, Corticosteroids

Disqualifiers: Gastroparesis, Renal disease, others

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

Compensation: Varies

Number of Visits: 4

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking medications other than insulin that affect blood sugar, you must have been on a stable dose for more than three months to participate.

What data supports the effectiveness of the treatment Missed Dose + 15min walk for type 1 diabetes?

Research shows that regular physical activity is important for managing type 1 diabetes, as it can help improve metabolic control. Although specific studies on a 15-minute walk after a missed dose are not available, general guidelines recommend physical activity for better diabetes management. ^{1 2 3 4 5}

Is physical activity safe for people with type 1 diabetes?

Physical activity is generally safe for people with type 1 diabetes, but it can cause changes in blood sugar levels, leading to a risk of low blood sugar (hypoglycemia). It's important to monitor blood sugar and adjust insulin and food intake as needed to stay safe. ^{1 5 6 7 8}

How does the 'Missed Dose + 15min walk' treatment for Type 1 Diabetes differ from other treatments?

The 'Missed Dose + 15min walk' treatment is unique because it combines a missed insulin dose with a short walk, which may help manage blood sugar levels without the immediate risk of hypoglycemia (low blood sugar) that can occur with exercise. This approach is different from traditional insulin adjustments or exercise routines, as it specifically addresses the timing and intensity of physical activity to prevent low blood sugar in people with Type 1 Diabetes. ^{9 10 11 12 13}

What is the purpose of this trial?

People living with type 1 diabetes (PwT1D) are recommended to administer insulin 10-15 minutes before meal consumption (pre-bolus), to account for the delay in the glucose lowering action associated with subcutaneously administered insulin. Due to the demands of day-to-day life, pre-bolusing is not always possible or may be forgotten. With continuous glucose monitors (CGMs), PwT1D may be alerted to this missed insulin dose by a CGM alert, including rapidly rising glucose (change \>2.5mmol/L/15min) or hyperglycemia (\>10.0 mmol/L), and deliver a mistimed (post-prandial) dose in response to CGM alert. This study was designed to determine the effect of combining a post-prandial/mistimed insulin dose with 15 minutes of brisk walking. It is expected that walking will help to minimize or prevent hyperglycemia after a mistimed bolus insulin dose, as well as blunt the rise in glucose following a mistimed insulin dose.

Eligibility Criteria

This trial is for people with type 1 diabetes who sometimes miss their pre-meal insulin dose. Participants should be using a continuous glucose monitor (CGM) and be able to walk briskly for 15 minutes. Specific inclusion or exclusion criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Estimated glycated hemoglobin or glucose management indicator obtained from the past 30 days of CGM data of < 9.9%

Use a Dexcom G7 CGM in routine care

I have been diagnosed with Type 1 diabetes for at least two years.

Exclusion Criteria

Having a condition that could render exercise harmful

My kidney function is significantly impaired.

I cannot give informed consent because of cognitive issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretest Measures

Participants undergo pretest measures including diabetes management questions, resting blood pressure, heart rate, and anthropometric measurements. They also complete questionnaires and perform a maximal aerobic capacity test.

1-2 weeks

1 visit (in-person)

Testing Sessions

Participants attend three separate testing sessions to consume a standardized meal and administer insulin under different conditions, including a 15-minute walk.

3 sessions over 3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the testing sessions, focusing on glucose levels and insulin delivery.

4 weeks

Treatment Details

Interventions

• Missed Dose + 15min walk

Trial Overview The study tests if walking for 15 minutes after eating can prevent high blood sugar when the pre-meal insulin dose is missed. It compares three scenarios: no missed dose (CON), missed dose without exercise (MISS), and missed dose followed by a walk (MISS+EX).

Participant Groups

Group I: All participants Experimental Treatment 3 Interventions

All participants will be in a single arm that undergoes three separate interventions. These interventions will include three different mealtime insulin administration: i) 15 minutes prior to eating, ii) post-prandially when alerted to rapidly rising glucose (increase of 0.2 mmol/L/min) or hyperglycemia (\> 10.0 mmol/L) by CGM, and iii) the same conditions as ii) but with a 15-minute walk performed immediately after insulin administration.

Who Is Running the Clinical Trial?

Jane Yardley

Lead Sponsor

Trials

1

Recruited

30+

Diabetes Québec

Collaborator

Trials

1

Recruited

30+

Diabetes Québec

Collaborator

Trials

7

Recruited

1,600+

Findings from Research

In a study of 130 adult patients with type 1 diabetes, those who engaged in more than 150 minutes of intense physical activity per week had significantly lower HbA1c levels, indicating better metabolic control.

No significant improvements in metabolic control were observed for patients who participated in moderate physical activity, suggesting that intense exercise may be more beneficial for managing blood sugar levels in type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense physical activity is associated with better metabolic control in patients with type 1 diabetes. Carral, F., Gutiérrez, JV., Ayala, Mdel C., et al.[2018]

In a study involving nine adolescents with type 1 diabetes, it was found that glucose infusion rates needed to maintain stable blood sugar levels were higher during and shortly after exercise, indicating an increased risk of hypoglycemia immediately following physical activity.

The research revealed a biphasic pattern of glucose requirements, suggesting that adolescents may face both immediate and delayed risks of nocturnal hypoglycemia after exercising, highlighting the need for careful monitoring and management of glucose levels post-exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose requirements to maintain euglycemia after moderate-intensity afternoon exercise in adolescents with type 1 diabetes are increased in a biphasic manner. McMahon, SK., Ferreira, LD., Ratnam, N., et al.[2022]

In a study involving 10 adolescents with type 1 diabetes, moderate-intensity exercise performed at midday significantly increased the glucose infusion rate (GIR) needed to maintain normal blood sugar levels, indicating a heightened risk of hypoglycemia during and after exercise.

Unlike previous findings of a biphasic pattern of hypoglycemia risk after late-afternoon exercise, this study found that the risk of hypoglycemia remained elevated for several hours post-exercise without showing a second peak, suggesting different management strategies may be needed based on the timing of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of midday moderate-intensity exercise on postexercise hypoglycemia risk in individuals with type 1 diabetes. Davey, RJ., Howe, W., Paramalingam, N., et al.[2013]

In a study involving 48 adults with type 1 diabetes, the use of mini-dose glucagon significantly reduced the incidence of exercise-associated hypoglycemia (EAH) during aerobic exercise, with only 12% experiencing hypoglycemia when using glucagon compared to 39% with a placebo.

Both glucagon treatment arms showed a lower incidence of hypoglycemia without significant differences in adverse events, suggesting that mini-dose glucagon is a safe and effective option for managing blood sugar levels during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mini-Dose Ready-to-Use Liquid Glucagon on Preventing Exercise-Associated Hypoglycemia in Adults With Type 1 Diabetes. Aronson, R., Riddell, MC., Conoscenti, V., et al.[2023]

In a study involving 8 male type 1 diabetic patients, reducing premeal insulin doses significantly decreased the risk of exercise-induced hypoglycemia during postprandial exercises of varying intensities and durations.

Specifically, a 50% reduction in premeal insulin was effective for low-intensity exercise, while a 75% reduction was necessary for high-intensity exercise, leading to a 75% decrease in hypoglycemia incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for premeal insulin dose reduction for postprandial exercise of different intensities and durations in type 1 diabetic subjects treated intensively with a basal-bolus insulin regimen (ultralente-lispro). Rabasa-Lhoret, R., Bourque, J., Ducros, F., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Intense physical activity is associated with better metabolic control in patients with type 1 diabetes. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Gaps in Knowledge and the Need for Patient-Partners in Research Related to Physical Activity and Type 1 Diabetes: A Narrative Review. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Physical activity patterns in type 1 diabetes in Spain: The SED1 study. [2023]

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

Leisure time physical activity is associated with poor glycemic control in type 1 diabetic women: the FinnDiane study. [2022]

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

Glucose requirements to maintain euglycemia after moderate-intensity afternoon exercise in adolescents with type 1 diabetes are increased in a biphasic manner. [2022]

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

The effect of midday moderate-intensity exercise on postexercise hypoglycemia risk in individuals with type 1 diabetes. [2013]

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

Effect of Mini-Dose Ready-to-Use Liquid Glucagon on Preventing Exercise-Associated Hypoglycemia in Adults With Type 1 Diabetes. [2023]

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

Safety and Feasibility Evaluation of Step Count Informed Meal Boluses in Type 1 Diabetes: A Pilot Study. [2022]

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

Insulin-based strategies to prevent hypoglycaemia during and after exercise in adult patients with type 1 diabetes on pump therapy: the DIABRASPORT randomized study. [2022]

10. France pubmed.ncbi.nlm.nih.gov

Timing of insulin basal rate reduction to reduce hypoglycemia during late post-prandial exercise in adults with type 1 diabetes using insulin pump therapy: A randomized crossover trial. [2020]

11. Canada pubmed.ncbi.nlm.nih.gov

Vigorous intensity exercise for glycemic control in patients with type 1 diabetes. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Association of aerobic fitness level with exercise-induced hypoglycaemia in Type 1 diabetes. [2022]

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

Guidelines for premeal insulin dose reduction for postprandial exercise of different intensities and durations in type 1 diabetic subjects treated intensively with a basal-bolus insulin regimen (ultralente-lispro). [2022]