Clinical trial NCT05514080: A Study to Evaluate Eli Lilly's Insulin Dosing Algorithm to Control Glycemia in Insulin-treated Adults With Type 2 Diabetes
Official title: A Pilot Study to Evaluate Eli Lilly's Insulin Dosing Algorithm to Control Glycemia in Insulin-treated Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Insulin pump therapy
Eli Lilly
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose outcomes: percentage of time spent in specific glucose ranges (ex: 3.9-10.0 mmol/L)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre for Innovative Medicine at McGill University Health Centre Research Institute
state: Quebec
Study officials:
affiliation: Royal Victoria Hospital, Belfast
name: Michael Tsoukas, MD
role: PRINCIPAL_INVESTIGATOR
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