Health TrialsbyHealthPanel

The Postprandial Hypo-Avoid Study

ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSteno Diabetes Center Copenhagen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Type 1 diabetes ≥ 2 years

Using an automated insulin delivery system for ≥ 3 months

NovoRapid or Fiasp use ≥1 week

Disqualifiers

Allergies to lactose or glucagon

Known or suspected allergies to glucagon or related products

History of hypersensitivity or allergic reaction to glucagon or lactose

Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low-Dose Glucagon

    Drug

    Participants will be given a low-dose of glucagon before starting the exercise session

  • Glucose Arm

    Dietary supplement

    Participants will be given a dose of glucose before starting exercise

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Visit GCNActive comparator 1 intervention
Group B: Visit CHOActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From exercise initiation until two hours following exercise

Secondary outcomes

1

Percent PG time in range (3.9-10.0 mmol/L) between visits GCN and CHO

Time frame
From exercise onset to +120 min
2

Incidence of hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO

Binary

Time frame
0-180 min
3

Time to hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO

Time frame
0-180 min
4

Percent time below range (PG <3.9 mmol/L) between visit GCN and CHO

Time frame
0-180 mins

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Steno Diabetes Center Copenhagen

Lead sponsor

Source ClinicalTrials.gov
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