Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

It had 1 arm (groups): one (experimental).

The registry classes the interventions as device and drug.

More on the Plan

Background and Introduction Cystic fibrosis-related diabetes (CFRD) is the most common extra-pulmonary comorbidity in patients with cystic fibrosis (CF).

Continuous glucose monitoring (CGM) involves the use of a small disposable sensor sited in the subcutaneous interstitial fluid that makes frequent glucose measurements.

To compare the frequency and duration of hypoglycemia (defined as the daily, weekly, and average duration of the event) between insulin delivery methods described above. 3.

To test the use of 'rule of 500' for carb counting estimation in patients with CFRD 4.

Who Took Part

13 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Age \>18 age of years. Diagnosis of cystic fibrosis related diabetes. Using basal bolus insulin. Cystic Fibrosis with Lung Transplantation.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: use of continuous glucose monitors; patient unable to check fingerstick blood sugars.

How the Study Was Run

Design: single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-09-15 with completion listed for 2023-07-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in Target (time frame: 2 weeks).

It also tracked 1 secondary outcome, for example Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin (regular human) in 13 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 Insulin (regular human) compound page, all human trials.