GX-01S / LinX CGM postmarket follow-up
What this study tests
PROMISE-GX plans to study glucose metrics and user experience with MicroTech’s GX-01S sensor and LinX app in adults with T1D or T2D. The registry still says not yet recruiting despite an estimated September 2026 start.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-09-09.
Most recent recorded citation date: 2026-09-09. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 18–75 with T1D or T2D and HbA1c above 7.5%, with stable diabetes treatment. Recent real-time CGM use and specified severe hypoglycemia, hyperglycemia and ketoacidosis histories are excluded; further criteria apply. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results are posted in ClinicalTrials.gov as of 17 September 2026. This record describes the registered study plan, not demonstrated benefit or safety.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions are not specified here. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Change in CGM time in range, above range and below range, comparing the 15-day blinded baseline with unblinded use at day 45.
The full picture
The single-arm study plans 100 adults, with at least 70% having T1D. Participants first wear blinded CGM for 15 days, followed by 120 days with visible glucose information through LinX. The sponsor describes planned European centers, but no country-level study locations are listed in the current registry.1
The primary outcomes compare glucose metrics at day 45 with the blinded baseline: time in range 70–180 mg/dL (3.9–10.0 mmol/L), above 180 mg/dL (10.0 mmol/L) and below 70 mg/dL (3.9 mmol/L). HbA1c change at day 135 is secondary. There is no randomized comparator.1
The registry calls this postmarket follow-up and identifies the GX-01S system with the LinX app. That description does not independently verify the product’s approval, label or availability in any particular country.1
The registry lists study start 2026-09 (estimated), primary completion 2028-02 (estimated) and study completion 2028-06 (estimated). These dates retain the registry’s actual or estimated labels; an estimated date is not confirmation that an event occurred.1
Sources
- [1]PMCF Study of GX-01S CGM in Adults With Diabetes (NCT07802327) · Trial registry · 2026-09-09 — Current registered protocol, eligibility, endpoints and status checked 17 September 2026; the citation date records the registry update, not a results publication.
ClinicalTrials.gov. NCT07802327. Last update posted 2026-09-09; checked 17 September 2026.