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

NCT06082973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-18

No results posted yet for this study

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

Interventions

DEVICE

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

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.

DEVICE

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

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.

Sponsors & Collaborators

  • Hospital Clínico Universitario de Valencia

    collaborator OTHER

  • Universitat Politècnica de València

    lead OTHER

Principal Investigators

  • F. Javier Ampudia-Blasco, MD PhD · Hospital Clínico Universitario de Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06082973 on ClinicalTrials.gov