Smart pancreas showdown: can Dual-Hormone tech beat low blood sugar?
NCT ID NCT06082973
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two versions of an artificial pancreas in 15 adults with type 1 diabetes. One version used only insulin with automatic carb suggestions, while the other added glucagon to prevent low blood sugar. Participants underwent exercise and meal challenges to see which system kept glucose levels safer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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May 2024
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
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Other studies related to the condition(s) this trial covers.
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