Dual-hormone Artificial Pancreas Versus Single-hormone Under Exercise and a Meal Challenge

NCT06082973 | Completed

• 1 other identifier: TAILOR/3
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The present clinical trial aims to examine alternative strategies for preventing/mitigating hypoglycemic events among adults with type 1 diabetes utilizing a highly personalized control system. This system offers two configurable options: a single-hormone configuration with automatic rescue carbohydrate recommendations (sHC) and a dual-hormone configuration with subcutaneously administered glucagon boluses (dHmG). The main question addressed in this study focuses on determining whether the dHmG outperforms the sHC in terms of minimizing the time spent below the target range and number of hypoglycemic events. Each participant will undergo two 12-hour controlled inpatient studies, including each an unannounced 30-min aerobic exercise session and a meal challenge. The order of these studies, comparing the dHmG to the sHC, will be randomized.

Conditions

Type 1 Diabetes

Keywords

artificial pancreas; glucagon

Outcome Measures

Primary Outcomes (2)

• % time below range (<70 mg/dL)

  Percentage of time spent below the target range

  12-hour inpatient study

• Number of Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL) hypoglycemic events

  Occurrence of hypoglycemic events during at least 15 min

  12-hour inpatient study

Secondary Outcomes (13)

• %time in range (70-180 mg/dL)

  12-hour inpatient study

• %time in range (70-140 mg/dL)

  12-hour inpatient study

• Time with glucose levels <3.0 mmol/l (54 mg/dl)

  12-hour inpatient study

• Coefficient of variation (CV) of CGM values

  12-hour inpatient study

• %time >180 mg/dL

  12-hour inpatient study

Study Arms (2)

Dual-hormone configuration system (insulin and glucagon)

EXPERIMENTAL

12-hour inpatient study that will include an unannounced 30-min aerobic exercise session and a meal challenge. Automated insulin and glucagon delivery will be performed using a dual-hormone configuration system for glucose control .

Device: Automated insulin delivery system algorithm with a dual-hormone configuration (insulin and glucagon) for glucose control

Single-hormone configuration (insulin) with carbohydrate recommendations system

ACTIVE COMPARATOR

12-hour inpatient study that will include an unannounced 30-min aerobic exercise session and a meal challenge. Automated insulin delivery will be performed using a single-hormone configuration system with carbohydrate recommendations if needed for glucose control .

Device: Automated insulin delivery system with a single-hormone configuration (insulin) with rescue carbohydrate recommendations for glucose control

Interventions

Automated insulin delivery system algorithm with a dual-hormone configuration (insulin and glucagon) for glucose control DEVICE

Participants will wear a CSII system with the CGM device. Insulin will be administered through the AID dHmG system, and microdoses of glucagon (GlucaGen®) will be subcutaneously administered based on automatic recommendations for hypoglycemia mitigation. The subcutaneous administration of reconstituted glucagon will be conducted using a 0.5 mL insulin syringe with needle, allowing for precise doses as small as 0.01mg/0.01 mL.

Also known as: Dual-hormone configuration system controller

Dual-hormone configuration system (insulin and glucagon)

Automated insulin delivery system with a single-hormone configuration (insulin) with rescue carbohydrate recommendations for glucose control DEVICE

Participants will wear a CSII system with the CGM device. Insulin will be administered through the AID sHC system, along with automatic rescue carbohydrate recommendations for hypoglycemia mitigation. As per the carbohydrate recommendation, participants will received the suggested amount of carbohydrates using an oral glucose gel containing 15g of carbohydrates per unit.

Also known as: Single-hormone configuration system with rescue carbohydrate recommendations controller

Single-hormone configuration (insulin) with carbohydrate recommendations system

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years.
• CSII treatment for a minimum of 6 months prior to Visit 1.
• Body mass index between 18 and 30 kg/m2.
• HbA1c level below 9.0% at Visit 1.

You may not qualify if:

• Postmenopausal women or women of childbearing age who have a negative urine pregnancy test during the screening visit.
• Pregnancy or breastfeeding.
• Hypoglycemia unawareness (as indicated by a Clarke Test score greater than 3).
• Presence of progressive, fatal disease.
• History of drug or alcohol abuse.
• History of being HIV positive, active hepatitis B or hepatitis C.
• Impaired liver function, as evidenced by serum glutamic-pyruvic transaminase (SGPT) or serum glutamic-oxaloacetic transaminase (SGOT) levels exceeding twice the upper limit of the reference normal range at Visit 1.
• Clinically significant microvascular complications (such as macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine, or other systemic conditions, apart from T1D, that may hinder the implementation of the clinical study protocol or the interpretation of study results.
• Scheduled surgery during the study period.
• Mental conditions that affect the subject's ability to comprehend the nature, purpose, and potential consequences of the study.
• Subjects deemed unlikely to adhere to the clinical study protocol, including those with an uncooperative attitude, inability to attend follow-up visits or low likelihood of completing the study.
• Use of an experimental drug or device within the past 30 days.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valencia: collaborator
• Universitat Politècnica de València: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (9)

• Lakshman R, Boughton C, Hovorka R. The changing landscape of automated insulin delivery in the management of type 1 diabetes. Endocr Connect. 2023 Jul 31;12(8):e230132. doi: 10.1530/EC-23-0132.

  PMID: 37289734 BACKGROUND

• Eckstein ML, Weilguni B, Tauschmann M, Zimmer RT, Aziz F, Sourij H, Moser O. Time in Range for Closed-Loop Systems versus Standard of Care during Physical Exercise in People with Type 1 Diabetes: A Systematic Review and Meta-Analysis. J Clin Med. 2021 May 31;10(11):2445. doi: 10.3390/jcm10112445.

  PMID: 34072900 BACKGROUND

• Brazeau AS, Rabasa-Lhoret R, Strychar I, Mircescu H. Barriers to physical activity among patients with type 1 diabetes. Diabetes Care. 2008 Nov;31(11):2108-9. doi: 10.2337/dc08-0720. Epub 2008 Aug 8.

  PMID: 18689694 BACKGROUND

• Paldus B, Morrison D, Lee M, Zaharieva DP, Riddell MC, O'Neal DN. Strengths and Challenges of Closed-Loop Insulin Delivery During Exercise in People With Type 1 Diabetes: Potential Future Directions. J Diabetes Sci Technol. 2023 Jul;17(4):1077-1084. doi: 10.1177/19322968221088327. Epub 2022 Apr 24.

  PMID: 35466723 BACKGROUND

• Zaharieva DP, Morrison D, Paldus B, Lal RA, Buckingham BA, O'Neal DN. Practical Aspects and Exercise Safety Benefits of Automated Insulin Delivery Systems in Type 1 Diabetes. Diabetes Spectr. 2023 May;36(2):127-136. doi: 10.2337/dsi22-0018. Epub 2023 May 15.

  PMID: 37193203 BACKGROUND

• Wilson LM, Jacobs PG, Castle JR. Role of Glucagon in Automated Insulin Delivery. Endocrinol Metab Clin North Am. 2020 Mar;49(1):179-202. doi: 10.1016/j.ecl.2019.10.008. Epub 2019 Dec 10.

  PMID: 31980117 BACKGROUND

• Haidar A. Insulin-and-Glucagon Artificial Pancreas Versus Insulin-Alone Artificial Pancreas: A Short Review. Diabetes Spectr. 2019 Aug;32(3):215-221. doi: 10.2337/ds18-0097.

  PMID: 31462876 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

• Laugesen C, Ranjan AG, Schmidt S, Norgaard K. Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study. Diabetes Care. 2022 Jun 2;45(6):1391-1399. doi: 10.2337/dc21-2304.

  PMID: 35475907 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Officials

• F. Javier Ampudia-Blasco, MD PhD

  Hospital Clínico Universitario de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jorge Bondia Company

Model Details: Device: closed-loop control algorithm with a dual-hormone configuration versus a single-hormone configuration with rescue carbohydrate recommendations for glucose control during an unannounced 30-min aerobic exercise session and a meal challenge.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 13, 2023
• Study Start: May 15, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)