Back to results

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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Insulin-alone closed-loop

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Pediatric, Artificial Pancreas

Eligibility Criteria

2 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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%.

Exclusion Criteria:

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.

Sites / Locations

McGill University Health Centre Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin alone closed-loop

Arm Description

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

Outcomes

Primary Outcome Measures

Time in range

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

Secondary Outcome Measures

Specific time in range

Percentage of time of glucose levels spent a. between 3.9 and 7.8 mmol/L; b. below 3.9 mmol/L; c. below 3.3 mmol/L; d. below 2.8 mmol/L; e. above 10.0 mmol/L; f. above 13.9 mmol/L; g. above 16.7 mmol/L.

Specific nighttime time in range

Percentage of time (00:00-6:00) of glucose levels spent a. below 3.9 mmol/L; b. between 3.9 and 7.8 mmol/L; c. between 3.9 and 10.0 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 10.0 mmol/L; g. above 13.9 mmol/L; h. above 16.7 mmol/L.

Mean glucose levels

Mean glucose levels.

Standard deviation of glucose levels and insulin delivery

Standard deviation of glucose levels and insulin delivery.

Coefficient of variance of glucose levels and insulin delivery

Coefficient of variance of glucose levels and insulin delivery.

Total insulin delivery

Total amount of insulin delivered.

Full Information

NCT ID

NCT04612257

First Posted

October 27, 2020

Last Updated

July 10, 2023

Sponsor

McGill University

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT04612257

Brief Title

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

Official Title

A Pilot Study to Assess Closed-loop Insulin Delivery to Regulate Glucose Levels in Children With Type 1 Diabetes in Outpatient Free-living Settings.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

The sponsor has requested to end the study prematurely due to the accumulation of delays caused by COVID-19 as potential participants were hesitant to allow staff members into their homes or stay at the hospital per the study design.

Study Start Date

June 18, 2019 (Actual)

Primary Completion Date

June 13, 2022 (Actual)

Study Completion Date

June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McGill University

Collaborators

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is a preliminary pilot study to generate data to optimize an insulin dosing algorithm to regulate glucose levels in children with type 1 diabetes. There will be up to two 40-hour test in outpatient settings, in which we will assess an insulin dosing algorithm. The two tests will allow us to compare different tunings in the same patient (this allows easier interpretation of the data). For example, if in a specific participant, the dosing algorithm reduced insulin delivery at night to avoid low blood glucose levesl but led to a rebound increase in glucose levels, then a second visit with a slightly different target range will help answer this question. The objective of this clinical trial is to assess the safety of our algorithm in children with type 1 diabetes in a free-living study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Pediatric, Artificial Pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin alone closed-loop

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Insulin-alone closed-loop

Intervention Description

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

Primary Outcome Measure Information:

Title

Time in range

Description

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

Time Frame

40-hour intervention

Secondary Outcome Measure Information:

Title

Specific time in range

Description

Time Frame

40-hour intervention

Title

Specific nighttime time in range

Description

Time Frame

40-hour intervention

Title

Mean glucose levels

Description

Mean glucose levels.

Time Frame

40-hour intervention

Title

Standard deviation of glucose levels and insulin delivery

Description

Standard deviation of glucose levels and insulin delivery.

Time Frame

40-hour intervention

Title

Coefficient of variance of glucose levels and insulin delivery

Description

Coefficient of variance of glucose levels and insulin delivery.

Time Frame

40-hour intervention

Title

Total insulin delivery

Description

Total amount of insulin delivered.

Time Frame

40-hour intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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%. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurent Legault, MD

Organizational Affiliation

Montreal Children's Hospital of the MUHC

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre Research Institute

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

340000

Citation

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.

Results Reference

background

PubMed Identifier

26379095

Citation

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.

Results Reference

background

PubMed Identifier

7956645

Citation

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.

Results Reference

background

PubMed Identifier

30692242

Citation

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.

Results Reference

background

PubMed Identifier

27208335

Citation

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.

Results Reference

background

PubMed Identifier

28426239

Citation

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.

Results Reference

background

PubMed Identifier

26072052

Citation

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.

Results Reference

background

PubMed Identifier

27704167

Citation

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.

Results Reference

background

PubMed Identifier

28094472

Citation

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.

Results Reference

background

PubMed Identifier

27191385

Citation

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.

Results Reference

background

PubMed Identifier

26066705

Citation

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.

Results Reference

result

PubMed Identifier

26523526

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs