NCT06082973Completed
Dual-hormone Artificial Pancreas Versus Single-hormone Under Exercise and a Meal Challenge
Evaluation of Dual-hormone Artificial Pancreas With Closed-loop Glucose Control Versus Single-hormone With Carbohydrate Recommendations Under Unannounced Exercise and Meal Challenge in Adults With Type 1 Diabetes.
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 5 Sept 2023
- Start date
- 15 May 2024
- Primary completion date
- 30 May 2025
- Lead sponsor
- Universitat Politècnica de València
- Diseases
- Type 1 diabetes
- NCT number
- NCT06082973
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 15 May 2024 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled surgery during the study period.
- Use of an experimental drug or device within the past 30 days.
Other illness
- Presence of progressive, fatal disease.
- History of drug or alcohol abuse.
- History of being HIV positive, active hepatitis B or hepatitis C.
- 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.
- Mental conditions that affect the subject's ability to comprehend the nature, purpose, and potential consequences of the study.
Lab values
- 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.
Other
- Pregnancy or breastfeeding.
- Hypoglycemia unawareness (as indicated by a Clarke Test score greater than 3).
- 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.
Who the study is looking for
- 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.
- Physical examination, laboratory data, and ECG (electrocardiogram) results are within normal limits. Clinically insignificant abnormalities, as determined by the investigator, will not be considered exclusion criteria.
- Postmenopausal women or women of childbearing age who have a negative urine pregnancy test during the screening visit.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.