Smart insulin pump aims to take the guesswork out of diabetes management
NCT ID NCT05799781
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new fully-closed insulin delivery system that automatically adjusts insulin based on activity and missed meals, compared to a standard hybrid system. 29 adults with type 1 diabetes used both systems to see which kept blood sugar in a healthy range more often. The goal is to make diabetes management easier and safer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MPC closed-loop insulin delivery system (device)
- What this could lead to
- If successful, this could lead to a more automated insulin pump that better manages blood sugar without manual meal boluses, reducing the burden for people with type 1 diabetes.
- What could go wrong
- This is a small, early-stage study with only 29 participants, so results may not apply to everyone. The new algorithm may not outperform current systems and could have safety risks like low blood sugar.
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
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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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29 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Jan 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 years and older
- 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.
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: * Diagnosis of type 1 diabetes mellitus for at least 1 year. * Age 18 years and older. * Current use of a t:slim X2 insulin pump with Dexcom G6 with the use of Control IQ for at least 12 weeks. * Willingness to use Fiasp insulin during intervention study * Lives with another person age 18 or older who will sleep in the house at night and that can attend the training on using the system. * Lives within 40 miles of enrollment site. * HbA1c ≥ 7.5% at screening. * Total daily insulin requirement is less than 139 units/day. * Current use of a smartphone so can be contacted by study staff off-campus * Willingness to follow all study procedures, including attending all clinic visits. * Willingness to sign informed consent and HIPAA documents. Exclusion Criteria: * Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. * HbA1c \>10% at screening. * Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary. * Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as reported by the site laboratory). * Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator. * History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses. * History of diabetes ketoacidosis during the prior 6 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator. * Adrenal insufficiency. * Any active infection. * Known or suspected abuse of alcohol, narcotics, or illicit drugs. * Seizure disorder. * Active foot ulceration. * Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication. * Major surgical operation within 30 days prior to screening. * Use of an investigational drug within 30 days prior to screening. * Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus). * Bleeding disorder, treatment with warfarin, or platelet count below 50,000. * Allergy to Fiasp insulin. * Current administration of oral or parenteral corticosteroids. * Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer). * Current use of beta blockers or non-dihydropyridine calcium channel blockers. * Current use of any medication intended to lower glucose other than insulin (ex. use of metformin or liraglutide). * Gastroparesis * Low carbohydrate diet at the time of screening defines as less than 50 grams of carbohydrate per day. * Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol.
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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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Oregon Health and Science University
Portland, Oregon, 97239, United States
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University of Washington
Seattle, Washington, 98105, United States
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