New study to see how well two glucose monitors track blood sugar
NCT ID NCT07645313
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test how accurate and safe two continuous glucose monitoring (CGM) systems, the Anytime 5Pro and Anytime 4Pro, are in adults with type 1 or type 2 diabetes. About 70 participants will wear both devices at the same time and have their blood sugar measured during clinic visits. The goal is to confirm the devices work well in real-world conditions.
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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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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
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: 1. Diagnosis of type 1 or type 2 diabetes mellitus, documented in medical records, with diabetes established at least 6 months prior to Day 1. 2. Age \>= 18 years at the time of informed consent. 3. Stable vital signs at screening (systolic blood pressure 90-180 mmHg, diastolic blood pressure 50-110 mmHg, heart rate 50-100 bpm, body temperature 35.5-37.5 C). 4. Feasibility of establishing forearm venous access for repeated blood sampling. 5. Haematocrit \<= 70%. 6. For T1D participants: prior experience with a CGM system (any brand). 7. Willingness and ability to comply with the investigation procedures, including wearing both sensors (one Anytime 5Pro and one Anytime 4Pro) simultaneously throughout the 17-day participation period, attending six scheduled clinic visits, and participating in glucose manipulation procedures. 8. Written informed consent obtained prior to any investigation-related procedures. Exclusion Criteria: 1. Skin disorders at the prospective sensor insertion site (posterior-lateral upper arm), including scarring, redness, swelling, infection, or tattoos. 2. Known allergies to alcohol-based disinfectants or medical adhesives. 3. Coagulation abnormalities or bleeding disorders, or current use of anticoagulant therapy (except low-dose aspirin). 4. Current pregnancy, suspected pregnancy, or lactation. 5. History of epilepsy or psychiatric disorders that may compromise investigation compliance or subject safety during glucose manipulation procedures. 6. Severe hepatic or renal insufficiency. 7. Current use of medications known to interfere with CGM readings, including ascorbic acid (vitamin C) supplementation \>1000 mg/day. 8. Concurrent participation in another interventional device or drug trial, or participation within the past 30 days. 9. Known drug or alcohol abuse. 10. Any condition that, in the judgement of the investigator, would make the subject unsuitable for participation in this investigation or would compromise the subject's safety. 11. Planned magnetic resonance imaging (MRI), computed tomography (CT), X-ray examination, or diathermic therapy during the sensor wear period. \-
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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