Diabetes Mellitus, Type 2NCT05514080

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

A study testing Insulin closed-loop in people with Diabetes Mellitus, Type 2, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin closed-loop
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteCanada
Study dates: 6 Dec 2019to 30 Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To be eligible for the study, all participants must meet the following criteria:
Adult male or female ≥ 18 years of age.
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
Using multiple daily insulin injections (one basal and ≥ 2 prandial doses) for ≥ 3 months.
Using insulin glargine (U100 or U300), detemir, degludec, or NPH.
Most recent (in the last 6 month) HbA1c ≤ 10%.
Use of a GLP1 agonist or SGLT inhibitor for the past 3 months.

Who cannot join

Participants who meet any of the following criteria are not eligible for the study:
Severe hypoglycaemic episode ≤ two months before admission.
Ongoing pregnancy, or any newly diagnosed pregnancy throughout the study
Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
Recent (within the past 6 months) acute macrovascular event (e.g. acute coronary syndrome or cardiac surgery).
Peripheral vascular disease, foot ulcer, Charcot arthropathy or any condition that limits ability to walk
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Use of oral hypoglycaemic agents besides SGLTi's, GLP1 agonists, and or metformin and unwilling to discontinue for the run-in and intervention period.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Innovative Medicine at McGill University Health Centre Research Institute
Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Insulin closed-loop
Keywords: Insulin pump therapy, Eli Lilly
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin closed-loopOther
41-hour intervention period in which the participants are treated with rapid insulin in the closed-loop system.

Study groups in NCT05514080
Study group	Role	What they receive
Insulin alone closed-loop	Other	Not described Receives: Other: Insulin closed-loop

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 201930 Mar 2022

First posted24 Aug 2022
Study start6 Dec 2019
Primary completion4 Sep 2021
Study completion30 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05514080
Sponsor's protocol ID: 2020-5837
Status last verified: Aug 2022
First submitted: 1 Dec 2020
Last updated: 24 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65.
PubMed 9742977
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for the Study of Diabetes. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2009 Jan;52(1):17-30. doi: 10.1007/s00125-008-1157-y. Epub 2008 Oct 22.
PubMed 18941734
Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080.
PubMed 14578243
Pickup JC, Keen H, Parsons JA, Alberti KG. Continuous subcutaneous insulin infusion: an approach to achieving normoglycaemia. Br Med J. 1978 Jan 28;1(6107):204-7. doi: 10.1136/bmj.1.6107.204.
PubMed 340000
Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.
PubMed 24998009
Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, Acerini CL, Dellweg S, Benesch C, Heinemann L, Mader JK, Holzer M, Kojzar H, Exall J, Yong J, Pichierri J, Barnard KD, Kollman C, Cheng P, Hindmarsh PC, Campbell FM, Arnolds S, Pieber TR, Evans ML, Dunger DB, Hovorka R; New Collective Author. Home Use of an Artificial Beta Cell in Type 1 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2129-2140. doi: 10.1056/NEJMoa1509351. Epub 2015 Sep 17.
PubMed 26379095
Haidar A, Legault L, Matteau-Pelletier L, Messier V, Dallaire M, Ladouceur M, Rabasa-Lhoret R. Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Aug;3(8):595-604. doi: 10.1016/S2213-8587(15)00141-2. Epub 2015 Jun 8.
PubMed 26066705
Haidar A, Rabasa-Lhoret R, Legault L, Lovblom LE, Rakheja R, Messier V, D'Aoust E, Falappa CM, Justice T, Orszag A, Tschirhart H, Dallaire M, Ladouceur M, Perkins BA. Single- and Dual-Hormone Artificial Pancreas for Overnight Glucose Control in Type 1 Diabetes. J Clin Endocrinol Metab. 2016 Jan;101(1):214-23. doi: 10.1210/jc.2015-3003. Epub 2015 Nov 2.
PubMed 26523526
Gingras V, Rabasa-Lhoret R, Messier V, Ladouceur M, Legault L, Haidar A. Efficacy of dual-hormone artificial pancreas to alleviate the carbohydrate-counting burden of type 1 diabetes: A randomized crossover trial. Diabetes Metab. 2016 Feb;42(1):47-54. doi: 10.1016/j.diabet.2015.05.001. Epub 2015 Jun 10.
PubMed 26072052
Taleb N, Emami A, Suppere C, Messier V, Legault L, Ladouceur M, Chiasson JL, Haidar A, Rabasa-Lhoret R. Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. Diabetologia. 2016 Dec;59(12):2561-2571. doi: 10.1007/s00125-016-4107-0. Epub 2016 Oct 4.
PubMed 27704167
Haidar A, Messier V, Legault L, Ladouceur M, Rabasa-Lhoret R. Outpatient 60-hour day-and-night glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or sensor-augmented pump therapy in adults with type 1 diabetes: An open-label, randomised, crossover, controlled trial. Diabetes Obes Metab. 2017 May;19(5):713-720. doi: 10.1111/dom.12880. Epub 2017 Mar 8.
PubMed 28094472
Gingras V, Haidar A, Messier V, Legault L, Ladouceur M, Rabasa-Lhoret R. A Simplified Semiquantitative Meal Bolus Strategy Combined with Single- and Dual-Hormone Closed-Loop Delivery in Patients with Type 1 Diabetes: A Pilot Study. Diabetes Technol Ther. 2016 Aug;18(8):464-71. doi: 10.1089/dia.2016.0043. Epub 2016 May 18.
PubMed 27191385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Evaluate Eli Lilly's Insulin Dosing Algorithm to Control Glycemia in Insulin-treated Adults With Type 2 Diabetes
ClinicalTrials.gov ID: NCT05514080
Acronym / sponsor ID: 2020-5837
Conditions: Diabetes Mellitus, Type 2
Keywords: Insulin pump therapy, Eli Lilly
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: McGill UniversityUniversity, hospital or other
Study start: 6 Dec 2019 (actual)
Primary completion: 4 Sep 2021 (actual)
Study completion: 30 Mar 2022 (actual)
First posted: 24 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Insulin alone closed-loop	Other	Other: Insulin closed-loop

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Adult male or female ≥ 18 years of age.
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
Using multiple daily insulin injections (one basal and ≥ 2 prandial doses) for ≥ 3 months.
Using insulin glargine (U100 or U300), detemir, degludec, or NPH.
Most recent (in the last 6 month) HbA1c ≤ 10%.

Key exclusion criteria (8 listed)

Severe hypoglycaemic episode ≤ two months before admission.
Ongoing pregnancy, or any newly diagnosed pregnancy throughout the study
Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
Recent (within the past 6 months) acute macrovascular event (e.g. acute coronary syndrome or cardiac surgery).
Peripheral vascular disease, foot ulcer, Charcot arthropathy or any condition that limits ability to walk

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin closed-loop41-hour intervention period in which the participants are treated with rapid insulin in the closed-loop system.	Other	Insulin alone closed-loop

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
Background: PubMed 9742977Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65.
Background: PubMed 18941734Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for the Study of Diabetes. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2009 Jan;52(1):17-30. doi: 10.1007/s00125-008-1157-y. Epub 2008 Oct 22.
Background: PubMed 14578243Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080.
Background: PubMed 340000Pickup JC, Keen H, Parsons JA, Alberti KG. Continuous subcutaneous insulin infusion: an approach to achieving normoglycaemia. Br Med J. 1978 Jan 28;1(6107):204-7. doi: 10.1136/bmj.1.6107.204.
Background: PubMed 24998009Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.
Background: PubMed 26379095Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, Acerini CL, Dellweg S, Benesch C, Heinemann L, Mader JK, Holzer M, Kojzar H, Exall J, Yong J, Pichierri J, Barnard KD, Kollman C, Cheng P, Hindmarsh PC, Campbell FM, Arnolds S, Pieber TR, Evans ML, Dunger DB, Hovorka R; New Collective Author. Home Use of an Artificial Beta Cell in Type 1 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2129-2140. doi: 10.1056/NEJMoa1509351. Epub 2015 Sep 17.
Background: PubMed 26066705Haidar A, Legault L, Matteau-Pelletier L, Messier V, Dallaire M, Ladouceur M, Rabasa-Lhoret R. Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Aug;3(8):595-604. doi: 10.1016/S2213-8587(15)00141-2. Epub 2015 Jun 8.
Background: PubMed 26523526Haidar A, Rabasa-Lhoret R, Legault L, Lovblom LE, Rakheja R, Messier V, D'Aoust E, Falappa CM, Justice T, Orszag A, Tschirhart H, Dallaire M, Ladouceur M, Perkins BA. Single- and Dual-Hormone Artificial Pancreas for Overnight Glucose Control in Type 1 Diabetes. J Clin Endocrinol Metab. 2016 Jan;101(1):214-23. doi: 10.1210/jc.2015-3003. Epub 2015 Nov 2.
Background: PubMed 26072052Gingras V, Rabasa-Lhoret R, Messier V, Ladouceur M, Legault L, Haidar A. Efficacy of dual-hormone artificial pancreas to alleviate the carbohydrate-counting burden of type 1 diabetes: A randomized crossover trial. Diabetes Metab. 2016 Feb;42(1):47-54. doi: 10.1016/j.diabet.2015.05.001. Epub 2015 Jun 10.
Background: PubMed 27704167Taleb N, Emami A, Suppere C, Messier V, Legault L, Ladouceur M, Chiasson JL, Haidar A, Rabasa-Lhoret R. Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. Diabetologia. 2016 Dec;59(12):2561-2571. doi: 10.1007/s00125-016-4107-0. Epub 2016 Oct 4.
Background: PubMed 28094472Haidar A, Messier V, Legault L, Ladouceur M, Rabasa-Lhoret R. Outpatient 60-hour day-and-night glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or sensor-augmented pump therapy in adults with type 1 diabetes: An open-label, randomised, crossover, controlled trial. Diabetes Obes Metab. 2017 May;19(5):713-720. doi: 10.1111/dom.12880. Epub 2017 Mar 8.
Background: PubMed 27191385Gingras V, Haidar A, Messier V, Legault L, Ladouceur M, Rabasa-Lhoret R. A Simplified Semiquantitative Meal Bolus Strategy Combined with Single- and Dual-Hormone Closed-Loop Delivery in Patients with Type 1 Diabetes: A Pilot Study. Diabetes Technol Ther. 2016 Aug;18(8):464-71. doi: 10.1089/dia.2016.0043. Epub 2016 May 18.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Tsoukas, MD principal investigator

Royal Victoria Hospital, Belfast

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Insulin closed-loop in people with Diabetes Mellitus, Type 2, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose outcomes: percentage of time spent in specific glucose ranges (ex: 3.9-10.0 mmol/L) (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514080, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.