New glucose monitor aims for pinpoint accuracy in diabetes care
NCT ID NCT07679347
First seen Jul 01, 2026 · Last updated Jul 08, 2026 · Updated 3 times
Summary
This pilot study tests a new continuous glucose monitor (CGM) called SAVA in 20 adults with Type 1 Diabetes. Participants wear three SAVA sensors and one standard sensor for 15 days to check how well the SAVA measures blood sugar compared to lab tests. The study also looks at comfort and safety. Results will help decide if larger studies are worthwhile.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SAVA Continuous Glucose Monitor (device)
- What this could lead to
- If successful, this could lead to a more accurate and comfortable glucose monitor for people with Type 1 Diabetes.
- What could go wrong
- This is a small pilot study with only 20 participants, so results may not apply to everyone. The device may not meet accuracy targets or may cause discomfort.
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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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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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: * The participant is willing and able to give informed consent to participate in the study. * The participant is at least 18 years of age at the time of enrolment. * The participant has a clinical diagnosis of Type 1 diabetes, with 7% \< HbA1C \< 10% within the last 6 months, for a minimum of 6 months duration prior to enrolment, as determined by a medical record by an individual qualified to make a medical diagnosis, and is using insulin (either by an insulin pump, subcutaneous injections, and/or inhaled insulin) for at least 6 months prior to enrolment. * If participant is using noninsulin glucose-lowering medications (such as SGLT2I Inhibitor, Metformin, or other), dose has been stable for at least 2 weeks prior to screening. * The participant body weight is at least 110 pounds, in accordance with U.S. Department of Health and Human Services guidance for blood collection. * The participant has adequate venous access as assessed by an investigator or appropriate centre staff. * The participant is available to attend all three up to 8-hour, clinically supervised, in-clinic sessions and to have multiple venous and capillary blood samples collected. * The participant agrees to not consume Vitamin C for the duration of the study. * The participant is prepared to record details related to their participation (e.g. meals, finger prick times, device incidents, comfort) daily. * The participant is prepared to wear up to three blinded investigational devices, and one unblinded investigational device for 15 days. * In the investigators' opinion, are suitable for participation in the study. * The participant is able to read and understand English. * The participant is willing to return the research devices at the end of the study. * The participant is willing to manage diabetes with insulin during study visits as they would do otherwise. * The participant can commit to not getting the CGMs wet for the first 12 hours after application, such as by showering or swimming. Exclusion Criteria: * The participant gave birth within the last 6 months, is pregnant, is trying to conceive or is not willing and able to practice birth control during the study duration. * The participant has serious concomitant disorders or diseases (e.g. history of hypoglycaemia with unawareness requiring third party assistance, coagulation disorders) that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator. * The participant has had a recent cardiovascular event or major surgery in the last 6 months that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator. * The participant has been admitted to the hospital with Diabetic Ketoacidosis in the last 6 months prior to enrolment. * The participant has donated more than 500mL of blood in the past 4 weeks. * The participant has a blood haemoglobin (Hb) that is 10% or more below the normal reference range for men and women, at the discretion of the Investigator. * Current use of sulfonylurea medications. * Current use of GLP-1 Receptor Agonist medications. * The participant has an implanted medical device such as a pacemaker or an implantable cardioverter-defibrillator (ICD). * The participant has multiple tattoos, scars, active skin condition or wound, or significant dermatitis overlying the skin where devices are likely to be placed. * The participant has a known allergy or sensitivity to skin adhesives or sensor materials. * The participant is taking part in another interventional clinical study requiring blood sampling, an investigational drug or device during the 15-day wear period of this study. * The participant is not willing to suspend their hybrid closed loop (Automated Insulin Delivery) system during the clinic sampling session. * The participant has any X-ray or MRI scheduled at any time during the participation of the study. * Any other reason which, in the investigator's opinion, would compromise participant safety or data integrity.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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