Personalized Treatment for Low Blood Sugar

(PHOT Trial)

Overseen By Cathy Sun, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must be taking: Sulfonylurea, Insulin

Disqualifiers: Other diabetes, Hypoglycemia unawareness, others

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how personalized treatments can manage mild low blood sugar in people with type 2 diabetes. Participants choose between riding a recumbent exercise bike or delaying food intake to trigger mild hypoglycemia. They then select a carbohydrate treatment and recheck time that suits them best. The trial is open to individuals with type 2 diabetes who have been on sulfonylurea or insulin treatment for at least a month. As an unphased trial, it offers participants the chance to contribute to innovative diabetes management strategies tailored to individual needs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you must be taking sulfonylurea or insulin for at least one month before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a recumbent exercise bike can lower blood sugar levels during and after exercise. This drop, known as exercise-induced hypoglycemia, can occur in anyone, not just those with diabetes. While riding the bike effectively reduces blood sugar, monitoring levels is crucial to prevent them from dropping too low.

Similarly, not eating or delaying meals can increase the risk of low blood sugar, particularly for individuals with diabetes. Fasting or postponing meals can destabilize blood sugar, raising the likelihood of experiencing low levels.

Both using the exercise bike and delaying meals can lower blood sugar safely with supervision and regular monitoring. Participants should understand their body's reactions and be prepared to manage symptoms of low blood sugar, such as dizziness or shakiness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for low blood sugar because they're exploring innovative ways to manage mild hypoglycemia. Unlike the usual reliance on glucose tablets or sugary drinks to quickly raise blood sugar levels, this trial examines how delaying food intake or using a recumbent exercise bike can safely and effectively induce mild hypoglycemia. These methods provide a non-pharmacological approach, potentially reducing dependency on medications and offering more personalized strategies for managing blood sugar. By investigating these unique approaches, researchers hope to gain insights into alternative ways to stabilize blood sugar levels using lifestyle adjustments.

What evidence suggests that this trial's treatments could be effective for low blood sugar?

In this trial, participants will be assigned to one of two treatment arms to manage blood sugar levels. One arm uses a recumbent exercise bike, which research shows can help control blood sugar by enhancing the body's insulin use. Studies have shown that regular biking can improve glucose control and lead to lower blood sugar levels.

The other arm involves delaying food intake, which can also lower blood sugar levels but requires careful monitoring to avoid hypoglycemia. Research suggests that fasting can increase insulin sensitivity and help prevent sudden blood sugar spikes. However, caution is necessary, as this method can result in dangerously low blood sugar.

Both exercise and delaying food aim to manage blood sugar, but they work differently. Exercise improves insulin use, while delaying food reduces sugar levels by limiting intake. Participants in this trial will experience one of these approaches to evaluate their effectiveness in managing blood sugar. ^{2 4 6 7 8}

Who Is on the Research Team?

Cathy Sun, MD MSc

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 2 diabetes who have been taking sulfonylurea or any insulin for at least a month. They must consent to participate and not have other forms of diabetes, hypoglycemia unawareness, or a recent hypoglycemic event.

Inclusion Criteria

I have been taking diabetes medication, either sulfonylurea or insulin, for at least a month.

Consent provided

I am 18 years old or older.

Exclusion Criteria

Has a history of hypoglycemia unawareness

Had a hypoglycemia event, defined as capillary blood glucose < 3.9 mmol/L within 24 hours prior to the study visit booking time.

I have been diagnosed with a type of diabetes that is not type 1 or type 2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants choose one or both interventions: riding a recumbent exercise bike or delaying food intake after taking medication to induce mild hypoglycemia.

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention, focusing on hypoglycemia resolution.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delaying food
• Recumbent Exercise Bike

Trial Overview The study tests the effectiveness of personalized treatments for mild low blood sugar using two methods: exercising on a recumbent bike or delaying meals. Participants choose their preferred carbohydrate treatment quantity and when to recheck blood glucose levels.

How Is the Trial Designed?

Group I: Recumbent Exercise Bike to induce mild hypoglycemia Experimental Treatment 1 Intervention

The participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia.

Group II: Delaying food to induce mild hypoglycemia Experimental Treatment 1 Intervention

At the study visit, in front of the study nurse, the participant takes their usual clinical care dose of sulfonylurea or basal insulin. If the participant's usual clinical care includes insulin with a rapid-acting component, then its dose is reduced based on the study protocol.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3004431/

Food Insecurity is Associated with Hypoglycemia and Poor ... Our main outcome was lifetime experience with hypoglycemia. Secondary outcomes included self-efficacy, medication and glucose-monitoring adherence, food ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2551657/

Glycemic Control and Hypoglycemia: Is the loser the winner? On the other hand, tight glycemic control can lead to hypoglycemia desensitization and reduced recognition of symptoms, thus risking a more severe drop in blood ...

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1301427/full

A low-glucose eating pattern is associated with ... The results to date have shown a benefit of time-restricted eating on GV, but only among adults with less favorable metabolic profiles (42).

4. sciencedirect.com sciencedirect.com/science/article/pii/S0168822723005910

The role of gastric emptying in glucose homeostasis and ... The results showed significant acceleration of GE during both mild and marked hypoglycemia when compared to euglycemia. Emptying was more rapid during marked as ...

5. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S128/157561/6-Glycemic-Goals-and-Hypoglycemia-Standards-of

6. Glycemic Goals and Hypoglycemia: Standards of Care in ... Individuals on a variety of insulin treatment plans can benefit from CGM with improved glucose levels, decreased hypoglycemia, and enhanced self ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10465985/

Food Insecurity and Diabetes: Overview of Intersections ... Food insecurity is associated with more labile blood sugars, i.e., higher incidence of both hyperglycemia (as measured by HbA1c) and hypoglycemia (as measured ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10371233/

Short-term fasting lowers glucagon levels under ... Fasting is associated with increased susceptibility to hypoglycemia in people with type 1 diabetes, thereby making it a significant health risk.

8. mayoclinic.org mayoclinic.org/diseases-conditions/diabetic-hypoglycemia/symptoms-causes/syc-20371525

Diabetic hypoglycemia - Symptoms & causes Low blood sugar can make you feel awful, and it can be dangerous. Learn about symptoms and treatments for people with diabetes who have low blood sugar.