SmartGuide CGM and Predict versus fingerstick monitoring
What this study tests
A randomized study compares Accu-Chek SmartGuide with its Predict app against fingerstick glucose monitoring in adults with type 1 or insulin-treated type 2 diabetes. The planned primary outcome is change in time in range.
Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).
Registry checked: 2026-09-17. Registry’s own update: 2026-08-28.
Latest dated source in the citation list: 2026-08-28. This is the source’s date, not a new review of every claim.
Trial status, labels and access can change between reviews. Review coverage and open work · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 18 or older with T1D or T2D diagnosed at least one year earlier, using multiple daily injections for at least six months, HbA1c 8–10%, and no CGM or flash monitoring in the preceding six months. Additional exclusions 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: European Union, Other regions. 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 16 September review-note archive and current review coverage. Later changes and new records may not appear in the earlier notes. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Change in time in range 70–180 mg/dL (3.9–10.0 mmol/L), comparing baseline weeks 1–2 with assessment weeks 5–6.
The full picture
This open-label, randomized parallel-group study plans to enroll 270 adults. The intervention includes both SmartGuide apps. The control group continues fingerstick monitoring and wears a blinded SmartGuide sensor during assessment periods; participants cannot view those CGM data or prediction functions.1
The population includes both T1D and insulin-treated T2D on multiple daily injections. It does not establish outcomes specifically for T1D, pump users or people already using CGM. The listed study countries are Poland and Türkiye.1
The primary assessment is early change in time in range. Later time-in-range assessments at weeks 13–14 and 25–26, hypoglycemia measures, HbA1c and person-reported outcomes are secondary endpoints, not reported findings.1
The registry lists study start 2025-04-14 (actual), primary completion 2026-11-15 (estimated) and study completion 2027-05-30 (estimated). These dates retain the registry’s actual or estimated labels; an estimated date is not confirmation that an event occurred.1
References
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ClinicalTrials.gov. NCT06704672. Last update posted 2026-08-28; checked 17 September 2026. https://clinicaltrials.gov/study/NCT06704672 ↩ ↩2 ↩3 ↩4
Sources
- [1]Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus (NCT06704672) · Trial registry · 2026-08-28 — Current registered protocol, eligibility, endpoints and status checked 17 September 2026; the citation date records the registry update, not a results publication.