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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a short walk can help people with type 1 diabetes manage blood sugar if they miss taking insulin before a meal. Participants will test different insulin administration methods, including post-meal dosing, and assess whether a 15-minute brisk walk helps control blood sugar spikes. The trial is designed for adults who have had type 1 diabetes for at least two years and regularly use a Dexcom G7 glucose monitor. As an unphased trial, it offers participants the opportunity to contribute to innovative strategies for better diabetes management.

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 prior data suggests that this protocol is safe for people with type 1 diabetes?

Studies have shown that aerobic activities like walking can sometimes cause low blood sugar (hypoglycemia) in people with type 1 diabetes, especially if the exercise lasts 30 minutes or more. However, this study focuses on a short, 15-minute walk, which may reduce that risk.

Research suggests that exercise can help manage blood sugar levels. Participants should monitor their body's reactions, especially if they haven't tried this timing of insulin and exercise before.

Overall, this approach is considered safe, but discussing individual circumstances with a doctor is advised. A doctor can provide guidance on how this might work for each person. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how timing and physical activity can optimize insulin administration for people with Type 1 diabetes. Unlike traditional insulin dosing, which is typically done at mealtime, this approach looks at giving insulin in response to real-time glucose changes detected by a continuous glucose monitor (CGM), potentially improving glucose control. Additionally, incorporating a brief 15-minute walk after insulin administration could enhance insulin sensitivity and help better manage blood sugar spikes. This innovative combination of technology and lifestyle intervention could offer a more dynamic and personalized way to manage Type 1 diabetes.

What evidence suggests that combining a mistimed insulin dose with a 15-minute walk is effective for managing type 1 diabetes?

Research has shown that walking after a meal can help manage blood sugar levels. One study found that a 15-minute walk after eating can improve sugar levels, making it an easy activity to incorporate into daily life. This trial will explore the effects of different mealtime insulin administration strategies, including a scenario where participants take a 15-minute walk after insulin administration when alerted to rapidly rising glucose or hyperglycemia. Another study found that reducing insulin during exercise can prevent low blood sugar in children with type 1 diabetes. This suggests that exercise, like walking, can safely help control sugar levels. Overall, this trial tests combining a missed insulin dose with a short walk as a potential way to manage rising blood sugar levels in people with type 1 diabetes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7538501/

Effect of postprandial moderate-intensity walking for 15-min ... These results suggest that postprandial moderate-intensity walking, easily performable in daily life activities, was effective for improving glucose ...

2. diabetesjournals.org diabetesjournals.org/care/article/29/10/2200/23571/Prevention-of-Hypoglycemia-During-Exercise-in

Prevention of Hypoglycemia During Exercise in Children With ... CONCLUSIONS—Discontinuing basal insulin during exercise is an effective strategy for reducing hypoglycemia in children with type 1 diabetes, but ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S016882272400891X

A T1DEXI adults and pediatric cohort analyses Predominantly aerobic activities (like walking, running and cycling) lasting 30 min or more tend to promote high risk for hypoglycemia, especially if the ...

4. researchgate.net researchgate.net/publication/319415153_Impact_of_post-meal_and_one-time_daily_exercise_in_patient_with_type_2_diabetes_mellitus_A_randomized_crossover_study

(PDF) Impact of post-meal and one-time daily exercise in ... Results: Group A patients showed a significant improvement in five point blood glucose profile and HbA1c after performing post-meal exercise (p ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7510016/

Postexercise Glycemic Control in Type 1 Diabetes Is ... This study examined the impact of residual β-cell function on CGM outcomes after a bout of aerobic exercise in people with T1D. We hypothesized that individuals ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10107219/

ISPAD Clinical Practice Consensus Guidelines 2022: Exercise ... In the long term, elevated HbA1c levels in youth with T1D may impact growth and development and likely adversely affect musculoskeletal health. For youth with ...

7. diabetesjournals.org diabetesjournals.org/care/article/47/5/849/154296/Exploring-Factors-That-Influence-Postexercise

Exploring Factors That Influence Postexercise Glycemia in ... In this large real-world pediatric exercise study, nocturnal hypoglycemia was higher on nights when average activity duration was higher.

8. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16103

Is low‐dose glucagon needed and effective in preventing ... Is low-dose glucagon needed and effective in preventing fasted exercise-induced hypoglycaemia in type 1 diabetes treated with the MiniMed 780G, ...