A Study to Evaluate Eli Lilly's Insulin Dosing Algorithm to Control Glycemia in Insulin-treated Adults With Type 2 Diabetes

August 23, 2022 updated by: McGill University

A Pilot Study to Evaluate Eli Lilly's Insulin Dosing Algorithm to Control Glycemia in Insulin-treated Adults With Type 2 Diabetes

The objective of this study is to generate preliminary data in an inpatient setting to help optimize an insulin dosing logic (that decides how much to deliver insulin) for Eli Lilly's system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, all participants giving written informed consent will undergo an admission visit to determine eligibility for study entry. Participants who meet the inclusion and exclusion criteria will then participate in two 41-hour intervention visits using Eli Lilly's insulin dosing algorithm.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Centre for Innovative Medicine at McGill University Health Centre Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To be eligible for the study, all participants must meet the following criteria:

  1. Adult male or female ≥ 18 years of age.
  2. Type 2 diabetes mellitus has been clinically diagnosed (the diagnosis of type 2 diabetes is based on the investigator's judgment) for at least 12 months
  3. Using multiple daily insulin injections (one basal and ≥ 2 prandial doses) for ≥ 3 months.
  4. Using insulin glargine (U100 or U300), detemir, degludec, or NPH.
  5. Most recent (in the last 6 month) HbA1c ≤ 10%.
  6. Use of a GLP1 agonist or SGLT inhibitor for the past 3 months.

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for the study:

  1. Severe hypoglycaemic episode ≤ two months before admission.
  2. Ongoing pregnancy, or any newly diagnosed pregnancy throughout the study
  3. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  4. Recent (within the past 6 months) acute macrovascular event (e.g. acute coronary syndrome or cardiac surgery).
  5. Peripheral vascular disease, foot ulcer, Charcot arthropathy or any condition that limits ability to walk
  6. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  7. Use of oral hypoglycaemic agents besides SGLTi's, GLP1 agonists, and or metformin and unwilling to discontinue for the run-in and intervention period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Insulin alone closed-loop
Other: Insulin closed-loop
41-hour intervention period in which the participants are treated with rapid insulin in the closed-loop system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose outcomes: percentage of time spent in specific glucose ranges (ex: 3.9-10.0 mmol/L)
Time Frame: 24 hours
As this is a pilot study, the only primary outcome is the glucose outcomes during the closed-loop portion.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Investigators

  • Principal Investigator: Michael Tsoukas, MD, Royal Victoria Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2019

Primary Completion (Actual)

September 4, 2021

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-5837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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