Ultra-Rapid Lispro Improves Postprandial Glucose Control and Time in Range in Type 1 Diabetes Compared to Lispro: PRONTO-T1D Continuous Glucose Monitoring Substudy

What Was Tested

This randomized controlled trial paper looks at Insulin Lispro.

The primary objective was to compare mealtime URLi and lispro with respect to incremental area under the serum glucose concentration versus time curve from 0 to 2 h (iAUC0-2h) after breakfast.

Why It Was Studied

Background: This study evaluated glucose control by continuous glucose monitoring (CGM) during treatment with ultra-rapid lispro (URLi) or lispro used in combination with insulin glargine or degludec in adults with type 1 diabetes in a substudy of the PRONTO-T1D study.

Blinded CGM was used for up to 14 days before baseline and the 26-week primary endpoint.

Who Took Part

The abstract describes 269 patients taking part.

The age groups tagged for this paper are adults.

Methods: Ambulatory glucose profiles were evaluated in 269 patients from PRONTO-T1D assigned to double-blind URLi (n = 97) or lispro (n = 99) given 0-2 min before the start of the meal (mealtime), or open-label URLi (n = 73) given 20 min after the meal (postmeal URLi).

How the Study Was Run

The researchers set it up as a randomized, double-blind, open-label and crossover study.

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

Blinding on both sides kept the patients and researchers unaware of who received Insulin Lispro.

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

In the crossover set-up each of the patients took both Insulin Lispro and the comparison in turn, acting as their own control.

What Was Measured

Background: This study evaluated glucose control by continuous glucose monitoring (CGM) during treatment with ultra-rapid lispro (URLi) or lispro used in combination with insulin glargine or degludec in adults with type 1 diabetes in a substudy of the PRONTO-T1D study.

Blinded CGM was used for up to 14 days before baseline and the 26-week primary endpoint.

Topics PubMed links to this paper include Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Glucose, Hypoglycemic Agents, Insulin Lispro and Postprandial Period.

Author keywords: Continuous glucose monitoring, Time in range, Type 1 diabetes and Ultra-rapid lispro.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Insulin Lispro in 269 patients.

The publication is from 2020 (Diabetes technology & therapeutics), a journal based in United States.

More context: the Insulin Lispro compound page, all human trials.