New CGM system aims to personalize diabetes management
NCT ID NCT04443153
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a continuous glucose monitor (CGM)-based advisory system to help adults with type 1 diabetes better manage their blood sugar. The system gives personalized advice based on glucose readings and the person's behavior and mindset. The goal was to improve glucose control and reduce the mental burden of diabetes management.
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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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88 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Sep 2024
- 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.
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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 18 years and older * Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least one year * HbA1c 6.0-11.0%, inclusive * Demonstration of proper mental status and cognition for the study * If on a non-insulin hyperglycemic therapy, stability on that therapy for the prior 3 months and willingness not to alter the therapy for the study duration. * For females, not currently known to be pregnant * If female and sexually active, must agree to use a highly effective form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. * Subjects must have Internet access and a computer system that meets the requirements for uploading the study equipment and ability to participate in video conferencing. * Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol Exclusion Criteria: * NPH (neutral protamine hagedorn) insulin * Use of any medication that at the discretion of the investigator is deemed to interfere with the trial. * Current treatment of a primary seizure disorder * Coronary artery disease or heart failure, unless written clearance is received from a cardiologist. * Hemophilia or any other bleeding disorder * A known medical condition, which in the opinion of the investigator or designee, would put the participant or study at risk such as the following examples: * Inpatient psychiatric treatment in the past 6 months * Presence of a known adrenal disorder * Abnormal liver function test results (Transaminase \>3 times the upper limit of normal) * Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2). * Active gastroparesis requiring medical therapy * Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L). * Abuse of alcohol or recreational drugs * Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection). * Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg). * Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months. * A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol. * Not familiar with smart phone technology * Current use of the following drugs and supplements: * Oral steroids * Any other medication that the investigator believes is a contraindication to the subject's participation * Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
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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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University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
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Other studies related to the condition(s) this trial covers.
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