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Robot 'Pancreas' tested in tiny diabetes study
NCT ID NCT05386849
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This small safety study tested a new artificial intelligence system called FUSION that automatically controls blood sugar levels in people with type 2 diabetes. Three participants who use insulin at home had their glucose managed by the device for 24 hours while eating standard meals. The main goal was to see how often blood sugar stayed in a safe range and how often it dropped too low.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FUSION closed loop glucose control system (a device that uses artificial intelligence to automatically adjust insulin and keep blood sugar in a target range)
- What this could lead to
- If successful, this could lead to a device that automatically manages blood sugar for type 2 diabetes patients, reducing the need for manual insulin adjustments.
- What could go wrong
- This was a very small, early safety study with only 3 participants. The device is designed for hospital use, not daily life, and may not work for all patients. More research is needed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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
-
3 people
The number who actually took part.
- Started
-
May 2022
- Finished
-
Jul 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Are 18-70 years of age, inclusive. 2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements. 3. Have had a diagnosis of type 2 diabetes for a period of at least 3 months. 4. Use insulin injections at home for glucose control. 5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%. 6. Have a hemoglobin in the normal range for sex: 1. Females: 12-15.5 grams/dL. 2. Males: 13.5-17.5 grams/dl. 7. Have adequate venous access sites in upper extremities. 8. Body weight between 40 - 150 kg. Exclusion Criteria: 1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening. 2. Have a known hypersensitivity to any of the components of study treatment. 3. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM. 4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant. 5. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being. 6. Have a clinically significant history or presence of any of the following conditions: 1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal. 2. Has an estimated GFR \<30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy. 3. Have congestive heart failure greater than class 1 on the NYHA classification system. 4. Have a history of seizures. 5. Have a history of cerebrovascular accident. 6. Have a history of ischemic heart disease. 7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if: 1. Pregnant. 2. Refuse to agree to a pregnancy test at the time of enrollment. 3. Have a positive urine pregnancy test at the time of enrollment. 8. Have a positive COVID-19 test within 14 days of visit 3. 9. Have any COVID-19 related symptoms in the 14-day period prior to visit 3. 10. Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.
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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
-
Emory University
Atlanta, Georgia, 30322, United States
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