Status:
COMPLETED
Dual-hormone Artificial Pancreas Versus Single-hormone Under Exercise and a Meal Challenge
Lead Sponsor:
Universitat Politècnica de València
Collaborating Sponsors:
Hospital Clínico Universitario de Valencia
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
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 s...
Detailed Description
RATIONALE OF THE STUDY Automated insulin delivery (AID), commonly referred to as artificial pancreas, represents the most advanced treatment for individuals with type 1 diabetes (T1D). AID is recogni...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06082973
Start Date
May 15 2024
End Date
May 30 2025
Last Update
December 18 2025
Active Locations (1)
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1
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010