Comparing dual-hormone and single-hormone artificial pancreas systems for type 1 diabetes management during exercise and meals
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.
This study is testing whether a new artificial pancreas that uses both insulin and glucagon can help people with type 1 diabetes manage their blood sugar better during exercise and meals compared to a system that only uses insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universitat Politècnica de València Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT06082973 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a dual-hormone artificial pancreas system, which administers both insulin and glucagon, compared to a single-hormone system that provides insulin with automatic carbohydrate recommendations. Participants, aged 18 to 65 with type 1 diabetes, will undergo two 12-hour inpatient studies that include an unannounced aerobic exercise session and a meal challenge, with the order of interventions randomized. The primary goal is to determine which system better minimizes hypoglycemic events and maintains blood glucose levels within the target range during these challenges.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with type 1 diabetes who have been on continuous subcutaneous insulin infusion for at least six months.
Not a fit: Patients who are pregnant, breastfeeding, or have hypoglycemia unawareness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glucose control and reduced hypoglycemic events for patients with type 1 diabetes.
How similar studies have performed: Previous studies have shown promise in using dual-hormone systems for diabetes management, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Valencia
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: F. Javier Ampudia-Blasco, MD PhD — Hospital Clínico Universitario de Valencia
- Study coordinator: F. Javier Ampudia-Blasco, MD PhD
- Email: ampudia_fra@gva.es
- Phone: +34 961 97 35 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.