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The objective of the study is to evaluate whether pre-exercise administration of low-dose subcutaneous glucagon prevents or attenuates exercise-induced declines in plasma glucose concentration during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes after a meal in adults with type 1 diabetes using an automated insulin delivery (AID) system.
The primary endpoint is the difference in the change in plasma glucose (PG) from exercise initiation to the nadir during exercise and through the 2-hour post-exercise period between the glucagon (GCN) and carbohydrate (CHO) visits.
This is a randomized, non-blinded, two-period crossover study including 18 adults with type 1 diabetes using an EU-approved automated insulin delivery (AID) system. Each participant will attend one screening visit followed by two experimental visits performed in random order, separated by at least seven days.
Eligible participants are adults (≥18 years) with type 1 diabetes for at least 2 years, using an automated insulin delivery system for ≥3 months, treated with NovoRapid or Fiasp for at least 1 week prior to enrollment, and proficient in carbohydrate counting.
At each experimental visit, participants will perform a standardized bout of MICE approximately 90 minutes after a meal. On one visit, a low-dose glucagon injection will be administered immediately before exercise; on the other, 20 g oral glucose tablets will be consumed. Right before exercise, the AID system's higher glucose target/exercise mode will be activated and will remain active until 15 minutes after exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visit GCN | Active Comparator | Plasma and sensor glucose are monitored before, during, and after a bout of moderate-intensity exercise shortly after consumption of a meal. Before exercise initiation, participants will be given low-dose glucagon to prevent hypoglycemia. |
|
| Visit CHO | Active Comparator | Plasma and sensor glucose are monitored before, during, and after a bout of moderate-intensity exercise shortly after consumption of a meal. Before exercise initiation, participants will be given a dose of glucose to prevent hypoglycemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Dose Glucagon | Drug | Participants will be given a low-dose of glucagon before starting the exercise session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma glucose (PG) from exercise initiation to the nadir during exercise and throughout the 2-hour post-exercise period between visit GCN and CHO | From exercise initiation until two hours following exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Percent PG time in range (3.9-10.0 mmol/L) between visits GCN and CHO | From exercise onset to +120 min | |
| Incidence of hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO | Binary | 0-180 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Lindkvist, MD, PhD Candidate | Contact | +45 21563054 | emilie.lindkvist@regionh.dk | |
| Sissel Lundemose, MD, PhD | Contact | +4523742764 | sissel.lundemose@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kirsten Nørgaard, MD, Professor | Steno Diabetes Center Copenhagen | Study Director |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Glucose Arm | Dietary Supplement | Participants will be given a dose of glucose before starting exercise |
|
| Time to hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO | 0-180 min |
| Percent time below range (PG <3.9 mmol/L) between visit GCN and CHO | 0-180 mins |
| Percent time above range (PG >10.0 mmol/L) between visits GCN and CHO | Continuous | 0-180 min |
| Incidence of hyperglycemia (PG >10.0 mmol/L) between visits GCN and CHO | Binary | 0-180 mins |
| Nadir PG concentration between visits GCN and CHO | Continuous | 0-180 mins |
| Peak PG concentration between visits GCN and CHO | Continuous | 0-180 mins |
| Incremental peak PG concentration between visits GCN and CHO | Continuous | 0-180 mins |
| Mean PG concentration between visits GCN and CHO | Continuous | 0-180 mins |
| PG area under the curve (AUC) between visits GCN and CHO | Continuous | 0-180 mins |
| Standard deviation of PG between visits GCN and CHO | Continuous | 0-180 mins |
| Coefficient of variation of PG between visits GCN and CHO | Continuous | 0-180 mins |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |