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

NCT05514080 | Completed

• 1 other identifier: 2020-5837
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Insulin pump therapy; Eli Lilly

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Study Arms (1)

Insulin alone closed-loop

OTHER

Other: Insulin closed-loop

Interventions

Insulin closed-loop OTHER

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

Insulin alone closed-loop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Centre for Innovative Medicine at McGill University Health Centre Research Institute

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (12)

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  PMID: 9742977 BACKGROUND

• 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.

  PMID: 18941734 BACKGROUND

• 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.

  PMID: 14578243 BACKGROUND

• 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.

  PMID: 340000 BACKGROUND

• 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.

  PMID: 24998009 BACKGROUND

• 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. 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.

  PMID: 26379095 BACKGROUND

• 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.

  PMID: 26066705 BACKGROUND

• 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.

  PMID: 26523526 BACKGROUND

• 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.

  PMID: 26072052 BACKGROUND

• 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.

  PMID: 27704167 BACKGROUND

• 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.

  PMID: 28094472 BACKGROUND

• 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.

  PMID: 27191385 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael Tsoukas, MD

  Royal Victoria Hospital, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: August 24, 2022
• Study Start: December 6, 2019
• Primary Completion: September 4, 2021
• Study Completion: March 30, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)