The POST-PRANDIAL HYPO-AVOID STUDY Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People with Type 1 Diabetes

Conditions

Type 1 Diabetes Mellitus

Brief summary

Change in plasma glucose (PG) from exercise initiation to the nadir during exercise and throughout the 2-hour post-exercise period.

Detailed description

Percent PG time in range (3.9–10.0 mmol/L) from exercise onset to +120 min (continuous), Incidence of hypoglycemia (PG <3.9 mmol/L; 0–180 min (binary), Time to hypoglycemia (PG <3.9 mmol/L; 0–180 min)., Percent time below range (PG <3.9 mmol/L; 0–180 min) (continuous), Percent time above range (PG >10.0 mmol/L; 0–180 min, (continuous), Incidence of hyperglycemia (PG >10.0 mmol/L; 0–180 min) (binary), Nadir PG concentration (0–180 min) (continuous), Peak PG concentration (0–180 min) (continuous), Incremental peak PG concentration (0–180 min) (continuous), Mean PG concentration (0–180 min) (continuous), PG area under the curve (AUC; 0–180 min) (continuous), Standard deviation of PG (0–180 min) (continuous), Coefficient of variation of PG (0–180 min) (continuous)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGZegalogue 0.6 mg solution for injection in pre-filled syringe

DRUGGlucaGen HypoKit

DRUGpulver og solvens til injektionsvæske

DRUGopløsning

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in plasma glucose (PG) from exercise initiation to the nadir during exercise and throughout the 2-hour post-exercise period.	—

Secondary

Measure	Time frame
Percent PG time in range (3.9–10.0 mmol/L) from exercise onset to +120 min (continuous), Incidence of hypoglycemia (PG <3.9 mmol/L; 0–180 min (binary), Time to hypoglycemia (PG <3.9 mmol/L; 0–180 min)., Percent time below range (PG <3.9 mmol/L; 0–180 min) (continuous), Percent time above range (PG >10.0 mmol/L; 0–180 min, (continuous), Incidence of hyperglycemia (PG >10.0 mmol/L; 0–180 min) (binary), Nadir PG concentration (0–180 min) (continuous), Peak PG concentration (0–180 min) (continuous), Incremental peak PG concentration (0–180 min) (continuous), Mean PG concentration (0–180 min) (continuous), PG area under the curve (AUC; 0–180 min) (continuous), Standard deviation of PG (0–180 min) (continuous), Coefficient of variation of PG (0–180 min) (continuous)	—

Measure

Time frame

Percent PG time in range (3.9–10.0 mmol/L) from exercise onset to +120 min (continuous), Incidence of hypoglycemia (PG <3.9 mmol/L; 0–180 min (binary), Time to hypoglycemia (PG <3.9 mmol/L; 0–180 min)., Percent time below range (PG <3.9 mmol/L; 0–180 min) (continuous), Percent time above range (PG >10.0 mmol/L; 0–180 min, (continuous), Incidence of hyperglycemia (PG >10.0 mmol/L; 0–180 min) (binary), Nadir PG concentration (0–180 min) (continuous), Peak PG concentration (0–180 min) (continuous), Incremental peak PG concentration (0–180 min) (continuous), Mean PG concentration (0–180 min) (continuous), PG area under the curve (AUC; 0–180 min) (continuous), Standard deviation of PG (0–180 min) (continuous), Coefficient of variation of PG (0–180 min) (continuous)

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Outcome results

None listed