Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan

What Was Tested

This registered not phased trial tested Glucagon.

It had two arms (groups): Glucagon injection (experimental) and Glucose tablets (active comparator).

Dextrose glucose tablets.

The registry classes the interventions as drug and other.

More on the Plan

This treatment method could also avert any negative psychological emotions Muslim people with diabetes may experience by ingesting carbohydrates to control hypoglycemia, thereby breaking their fast.

There will be two phases included in this study: 1.

Pre-crossover Phase: Before starting the crossover trial, a pre-crossover phase will conduct to evaluate hypoglycemia eligibility, frequency and compliance. 2.

Crossover Trial Phase: The Crossover Trial Phase will include 20 participants and consist of two (2-weeks) periods.

Who Took Part

Enrollment: 20 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 T1DM using daily insulin. 18.0 to \< 65.0 years of age with body mass index 20.0 to \<35.0 kg/m2. Having diabetes for ≥2.0 years. Has a smart phone with access to the internet and welling to upload data during the study period. Welling to wear a devise such as continuous glucose monitor ≥6 days/week.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: any history of more than one severe hypoglycemic episode (need assistance by third party) in the past 12 months; any history of more than one episode of diabetic ketoacidosis in the past 12 months; female pregnant or planning to get pregnant.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-04-15 with completion listed for 2019-06-10.

It ran at 1 site in Saudi Arabia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes in glucose values from baseline to 30 minute (time frame: 30 minutes).

It also tracked 19 secondary outcomes, for example Mean Glucose Value, during hypoglycemia event by CGM, Time in Range, during hypoglycemia event by CGM, Minimum Glucose, during hypoglycemia event by CGM, Maximum Glucose, during hypoglycemia event by CGM, Mean Glucose Value, during hypoglycemia event by CGM and Time in Range, during hypoglycemia event by CGM.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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