Assessing Closed-loop Insulin Delivery in Children With Type 1 Diabetes.

NCT04612257 | Terminated DMC

• 1 other identifier: 2020-5584
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to assess the safety of our insulin dosing algorithm in children with type 1 diabetes in a free-living study.

Conditions

Diabetes Mellitus, Type 1

Keywords

Pediatric; Artificial Pancreas

Outcome Measures

Primary Outcomes (1)

• Time in range

  Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).

  40-hour intervention

Secondary Outcomes (6)

• Specific time in range

  40-hour intervention

• Specific nighttime time in range

  40-hour intervention

• Mean glucose levels

  40-hour intervention

• Standard deviation of glucose levels and insulin delivery

  40-hour intervention

• Coefficient of variance of glucose levels and insulin delivery

  40-hour intervention

Study Arms (1)

Insulin alone closed-loop

EXPERIMENTAL

Insulin alone closed-loop algorithm in children with type 1 diabetes in a free-living study.

Other: Insulin-alone closed-loop

Interventions

Insulin-alone closed-loop OTHER

40-hour intervention period using the insulin-alone closed-loop system.

Insulin alone closed-loop

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female children between 2 and 13 years of age.
• Clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment).
• Using insulin pump therapy for at least 3 months
• For participants aged 7-13 years: Total daily insulin dose ≤ 40 units and 0.5 ≥ units/kg/day. For participants aged 2-6 years: Total daily insulin dose \[8, 40\] units and 0.3 ≥ units/kg/day.
• Most recent (in the last 6 months) HbA1c ≤ 12%.

You may not qualify if:

• Using Medtronic 670G automated insulin delivery system (since participant's basal rates and insulin-to-carbohydrate ratios may reflect the use of 670G; generally overestimated by 20%).
• Severe hypoglycaemia or ketoacidosis episode ≤ two months before admission.
• Medical illness or other issues likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Sponsors & Collaborators

• McGill University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

McGill University Health Centre Research Institute

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (12)

• 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

• 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

• Wasserman DH, Zinman B. Exercise in individuals with IDDM. Diabetes Care. 1994 Aug;17(8):924-37. doi: 10.2337/diacare.17.8.924. No abstract available.

  PMID: 7956645 BACKGROUND

• Tauschmann M, Allen JM, Nagl K, Fritsch M, Yong J, Metcalfe E, Schaeffer D, Fichelle M, Schierloh U, Thiele AG, Abt D, Kojzar H, Mader JK, Slegtenhorst S, Barber N, Wilinska ME, Boughton C, Musolino G, Sibayan J, Cohen N, Kollman C, Hofer SE, Frohlich-Reiterer E, Kapellen TM, Acerini CL, de Beaufort C, Campbell F, Rami-Merhar B, Hovorka R; KidsAP Consortium. Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Very Young Children: A Multicenter, 3-Week, Randomized Trial. Diabetes Care. 2019 Apr;42(4):594-600. doi: 10.2337/dc18-1881. Epub 2019 Jan 28.

  PMID: 30692242 BACKGROUND

• Del Favero S, Boscari F, Messori M, Rabbone I, Bonfanti R, Sabbion A, Iafusco D, Schiaffini R, Visentin R, Calore R, Moncada YL, Galasso S, Galderisi A, Vallone V, Di Palma F, Losiouk E, Lanzola G, Tinti D, Rigamonti A, Marigliano M, Zanfardino A, Rapini N, Avogaro A, Chernavvsky D, Magni L, Cobelli C, Bruttomesso D. Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe. Diabetes Care. 2016 Jul;39(7):1180-5. doi: 10.2337/dc15-2815. Epub 2016 May 10.

  PMID: 27208335 BACKGROUND

• DeBoer MD, Breton MD, Wakeman C, Schertz EM, Emory EG, Robic JL, Kollar LL, Kovatchev BP, Chernavvsky DR. Performance of an Artificial Pancreas System for Young Children with Type 1 Diabetes. Diabetes Technol Ther. 2017 May;19(5):293-298. doi: 10.1089/dia.2016.0424. Epub 2017 Apr 20.

  PMID: 28426239 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

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurent Legault, MD

  Montreal Children's Hospital of the MUHC

  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

Model Details: The pilot study aims to enroll 20 children participants with type 1 diabetes mellitus using insulin pump therapy. Each participant will undergo a 40-hour intervention period, with the possibility of being invited to a second 40-hour intervention period using the same system.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: June 18, 2019
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)