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

Diabetes Mellitus, Type 1 Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04612257
• Other study ID #: 2020-5584
• Status: Terminated
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: June 13, 2022

Study information

• Verified date: July 2023
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 13 Years

Eligibility

Inclusion Criteria:

1. Male or female children between 2 and 13 years of age.

2. Clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment).

3. Using insulin pump therapy for at least 3 months

4. 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.

5. Most recent (in the last 6 months) HbA1c = 12%.

Exclusion Criteria:

1. 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%).

2. Severe hypoglycaemia or ketoacidosis episode = two months before admission.

3. 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• Insulin-alone closed-loop
40-hour intervention period using the insulin-alone closed-loop system.

Locations

Country	Name	City	State
Canada	McGill University Health Centre Research Institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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 Dia — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in range	Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).	40-hour intervention
Secondary	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.	40-hour intervention
Secondary	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.	40-hour intervention
Secondary	Mean glucose levels	Mean glucose levels.	40-hour intervention
Secondary	Standard deviation of glucose levels and insulin delivery	Standard deviation of glucose levels and insulin delivery.	40-hour intervention
Secondary	Coefficient of variance of glucose levels and insulin delivery	Coefficient of variance of glucose levels and insulin delivery.	40-hour intervention
Secondary	Total insulin delivery	Total amount of insulin delivered.	40-hour intervention