The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

What Was Tested

The trial (phase 2) is built around Glucagon.

It had four arms (groups): Control (no intervention), one (active comparator), Glucose Tabs (active comparator) and G-Pen Mini™ (glucagon injection) (experimental).

The registry classes the interventions as drug and other.

More on the Plan

This is a randomized, 4-way crossover trial.

The trial will include 16 participants who complete the study.

The participant's pump will be blinded during the control trial, strategy 1, and strategy 3 and an injection of saline will be given during the control trial and strategy 1 so that participant is blinded to strategy.

The primary outcome for this study will be the glycemic response during exercise and early recovery.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin. Age 18-\<65 years. Duration of T1D ≥ 2 years. Random C-peptide \< 0.6 ng/ml. Using continuous subcutaneous insulin infusion (CSII; insulin pump) for at least 6 months, with no plans to discontinue pump use during the study.

The full record lists 13 inclusion and 10 exclusion criteria; among the exclusions: one or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment); active diabetic retinopathy (proliferative diabetic retinopathy or vitreous hemorrhage in past 6 months) that could potentially be worsened by exercise protocol; peripheral neuropathy with insensate feet.

How the Study Was Run

Design: randomized, crossover and single-blind.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2016-01 with completion listed for 2017-02-15.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Glycemic Response During Exercise and Early Recovery (time frame: 0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)).

It also tracked 11 secondary outcomes, for example Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose, CGM Metrics During Late Recovery - Peak Glucose, CGM Metrics During Late Recovery - Mean Glucose and CGM Metrics During Late Recovery - Coefficient of Variation.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glucagon compound page, all human trials.