Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Insulin (regular human).

Glucagon regulation and response in persons with T1D at the basal state and in response to various stimuli remains unclear.

It had two arms (groups): A (Pre-prandial insulin administration) : B (post-prandial insulin administration) (experimental) and B (post-prandial insulin administration) : A (Pre-prandial insulin administration) :b (experimental).

VISIT 1: Pre-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal. Then VISIT 2: Post-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min post the meal.

VISIT 1: Post-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min post the meal. Then VISIT 2: Pre-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal.

The registry classes the interventions as drug.

More on the Plan

Endogenous insulin secretion is almost entirely lost within 3 to 5 years after the diagnosis .

However, despite of these recent results, patients are often advised to give insulin after eating because caloric intake is uncertain.

Understanding the mechanisms behind the higher post-prandial peak in glucose with delayed insulin administration may help clinicians guide appropriate timing of insulin administration for T1D patients with long course of the disease.

Glucagon Regulation: Different models have been used to study glucagon regulation.

Who Took Part

The registry lists 1 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: 10 persons with T1D for \>5 years age \>18. Patients using either MDI or insulin pumps will be included. Patients using CGM will continue the use during the study, however glucoses will be measured by laboratory methods. Persons of all races, ethnicity and genders will be included.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: persons with type 2 diabetes, monogenic diabetes, pancreatic diseases; pregnancy, prisoners, other vulnerable populations or persons unable to understand the protocol and provide written informed consent; persons who take daily steroids, any route, for any purpose.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

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

It started in 2020-02-13 with completion listed for 2020-07-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: AUC Postprandial Glucagon (time frame: 4 hours).

It also tracked 1 secondary outcome, for example AUC Postprandial Glucose.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) in 1 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.