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Using glucagon and automated insulin delivery to prevent low blood sugar during exercise in adults with type 1 diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Type 1 Diabetes Mellitus, a condition where the body does not produce insulin, which is a hormone needed to regulate blood sugar. A common challenge for people with this condition is hypoglycemia, which occurs when blood sugar levels drop too low, often during physical activity. The purpose of the study is to evaluate whether using a low dose of dasiglucagon or glucagon can help prevent or reduce these dangerous drops in blood sugar levels during and after exercise.

Participants in the study will use an automated insulin delivery system, which is a technology that helps manage insulin levels automatically. During the study, individuals will receive a subcutaneous injection, meaning the medicine is injected just under the skin, before performing moderate exercise. The study examines how these medications affect blood sugar levels while performing continuous exercise approximately 90 minutes after eating a meal.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Meal consumption

    A meal is consumed.

  2. Step 2

    Medication administration

    Approximately 90 minutes after the meal, an injection of dasiglucagon (1200 µg) or glucagon (2000 mg) is administered via subcutaneous injection, which is an injection under the skin.

  3. Step 3

    Exercise period

    moderate-intensity continuous exercise (MICE) is performed.

  4. Step 4

    Monitoring period

    plasma glucose (sugar in the blood) levels are monitored during the exercise and for 2 hours after the exercise has finished.

Who can join the trial?

5 criteria

  • You must be older than 18 years of age.
  • You must have been living with Type 1 diabetes, a condition where the body does not produce insulin, for more than 2 years.
  • You must have been using an automated insulin delivery system, which is a device that automatically manages insulin levels, for at least 3 months.
  • You must have used the specific insulin types NovoRapid or Fiasp for at least one week before joining the study.
  • You must be skilled at carbohydrate counting, which is the ability to calculate the amount of sugar and starch in food to determine how much insulin is needed.

Who cannot join the trial?

10 criteria

  • Having an allergy, which is an immune system reaction, to lactose (a sugar found in milk) or glucagon (a hormone used to raise blood sugar levels).
  • Having a history of hypersensitivity, which means your body reacts unusually strongly to a substance.
  • Having a pheochromocytoma, which is a rare tumor found in the adrenal glands.
  • Having an insulinoma, which is a tumor in the pancreas that causes too much insulin to be produced.
  • Having gastroparesis, a condition where the stomach takes too long to empty its contents.
  • Having other medical or mental health conditions that a doctor determines make it unsafe or unsuitable for you to join the study.
  • Being unable to follow the specific rules and steps required by the study.
  • Being pregnant, breastfeeding, or planning to become pregnant.
  • Being a woman of childbearing age who is not using effective contraception, which are methods used to prevent pregnancy, such as birth control pills or an intrauterine device.
  • Being unable to understand the study information or unable to provide informed consent, which is the formal agreement to participate after understanding all the details.
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Investigated drugs

  • Zegalogue

    is an injection used to help raise blood sugar levels. It works by telling the liver to release stored sugar into the bloodstream, which helps prevent dangerously low blood sugar levels.

  • GlucaGen HypoKit

    is an injection used to treat very low blood sugar. Similar to other glucagon products, it works by stimulating the liver to release glucose into the blood to quickly increase sugar levels.

What is already known about the treatment

  • Dasiglucagon

    This medication is given as a shot under the skin using a pre-filled syringe. It is currently being studied for its ability to help manage blood sugar levels in people with type 1 diabetes. When injected, it works by signaling the liver to release stored sugar into the bloodstream to prevent dangerously low blood sugar levels. It belongs to a group of medicines known as glycogenolytic hormones.

  • Glucagon

    This medicine is administered through a subcutaneous injection using a powder and liquid kit that is mixed before use. It is a well-established treatment used to quickly raise blood sugar levels during emergencies. At a molecular level, it works by stimulating the liver to break down stored sugar and release it into the body. It is pharmacologically classified as a glycogenolytic hormone.

Investigated diseases

Type 1 Diabetes Mellitus - This is a condition where the body does not produce insulin, a hormone needed to regulate blood sugar. It occurs because the immune system mistakenly attacks and destroys the cells in the pancreas that make insulin. As the disease progresses, the lack of insulin causes sugar to build up in the bloodstream instead of being used for energy. This results in fluctuations in blood glucose levels.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523996-45-00Estimated enrolment18 patientsSponsorSteno Diabetes Center Copenhagen

sourced from the EU Clinical Trials Register and site verification

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