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Low Dose Empagliflozin in Adults With Type 1 Diabetes on Closed Loop Insulin System

NCT04450563 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-10-12

No results posted yet for this study

Summary

A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up of an insulin pump, a continuous glucose monitor, and an application communicating between the two to adjust insulin administration based on glucose control. This is meant for the treatment of type 1 diabetes. The McGill Artificial Pancreas (MAP) has been used previously in type 1 diabetes with significant benefits. Though prior studies have shown significant benefit with this system, some challenges still exist.

Empagliflozin is used in type 2 diabetes; it allows for glucose to be removed through the urine. Though its use is not approved in type 1 diabetes in North America, it (along with similar drugs) has been used in studies as adjunctive therapy with insulin with benefits on blood sugar control.

The purpose of our study is to see if a small dose of empagliflozin (2.5 mg and 5 mg) is enough to help those who cannot achieve adequate glucose control on a closed-loop insulin system.

The primary hypotheses of the study are the following:

1. The use of empagliflozin 2.5 mg daily will increase time in range compared to placebo for those on the closed-loop system.
2. The use of empagliflozin 5 mg daily will increase time in range compared to placebo for those on the closed-loop system.

Conditions

Interventions

DRUG

14-day outpatient intervention

The patient will be on the closed-loop insulin system and the intervention drug (placebo, empagliflozin 2.5 mg, or empagliflozin 5 mg) for 14 days. Insulin reductions will be made to avoid hypoglycemia with the drug agent. Remote contact around Day 4 (+/- 2 days) will be made to optimize insulin settings. The last 10 days will be used to assess continuous glucose monitoring data during each intervention. A wash-out period of 7 - 21 days will separate each intervention.

Sponsors & Collaborators

Principal Investigators

  • Ahmad Haidar, PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Michael Tsoukas, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Melissa-Rosina Pasqua, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2022-01-05
Completion
2022-01-13

Countries

  • Canada

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450563 on ClinicalTrials.gov