NCT03510000: CLASS15

Alleviating Carbohydrate-Counting Burden in T1DM Using Artificial Pancreas and Empagliflozin

Completed NA Last updated 24 June 2021

What this trial tests

NA trial testing Empagliflozin 25mg in Type1diabetes in 30 participants. Completed in 21 November 2019.

Timeline

15 May 2018

Primary endpoint
21 November 2019

21 November 2019

Quick facts

Lead sponsor	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	15 May 2018
Primary completion	21 November 2019
Estimated completion	21 November 2019
Sites	3 locations across Canada

Drugs / interventions tested

• Empagliflozin 25mg — full drug profile →
• Single hormone artificial pancreas
• Meal strategies

Conditions studied

• Type1diabetes — all drugs for Type1diabetes →

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Who can join

18 and older, any sex, with Type1diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One of the challenges in the design of the artificial pancreas (AP) is preventing postprandial hyperglycemia. Beyond algorithmic solutions, one countermeasure to postprandial hyperglycemia that may enhance performance of the AP is the use of adjunctive-to-insulin medications such as those in the Sodium Glucose-Linked Transporter 2 inhibitor class. This study evaluates whether use of oral empagliflozin on the background of single-hormone AP can improve postprandial blood glucose control. The investigators will test this hypothesis in a cross-over trial design by comparing open-label empagliflozin versus placebo in the setting of AP on separate study days that involve carbohydrate counting, simple meal announcement and no meal announcement strategies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.