SmartGuide Predict: behavior and fear of hypoglycemia
What this study tests
A recruiting German before-and-after study plans to enroll 89 adults with T1D or insulin-treated T2D. Participants use SmartGuide without Predict for two weeks, then with Predict for four weeks. The primary endpoint is change in fear of hypoglycemia; no results are posted.
Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).
Registry checked: 2026-09-17. Registry’s own update: 2026-09-11.
Most recent recorded citation date: 2026-09-11. 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. Review coverage and open work · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged at least 18 with T1D or T2D using intensified insulin therapy, CGM use during the past three months without predictive features, and HbA1c below 10%. Current SmartGuide users and AID users are excluded. Additional exclusions include diabetes duration under three months, current psychiatric medication, pregnancy and specified serious complications. 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. Registered endpoints and procedures are study plans, not evidence of 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. 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
- Within-person change in Hypoglycemia Fear Survey II score between week 2 and week 6, spanning four weeks with Predict.
The full picture
The registry describes an open-label, nonrandomized, single-group pre/post study conducted remotely in Germany, with no planned in-person visits. The two listed intervention arms are consecutive periods for the same participants: two weeks without Predict, then four weeks with Predict. They are not randomized parallel groups.1
The target enrollment is 89, marked estimated. The study includes both T1D and insulin-treated T2D; it should not be represented as a T1D-only trial. A subgroup of 10 is planned for interviews after six weeks. Secondary endpoints include sleep, diabetes distress, behavior and CGM glucose measures, rather than demonstrated improvements in these outcomes.1
The registry lists actual start on 1 February 2026 and estimated primary and study completion on 31 October 2026. Its first posting and latest update are both 11 September 2026, after the listed start. Overall status and the listed German site are recruiting in that record; this is not a guarantee that an individual can enroll.1
No results are posted. The design evaluates change after introducing predictive features without a randomized concurrent comparator, so any eventual before-and-after change will need that context. The trial excludes AID users, so it does not directly evaluate adding Predict to an AID system.1
References
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ClinicalTrials.gov. NCT07814508. Last update posted 2026-09-11; checked 17 September 2026. https://clinicaltrials.gov/study/NCT07814508 ↩ ↩2 ↩3 ↩4
Sources
- [1]Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App · Trial registry · 2026-09-11 — Original registry protocol, eligibility, outcomes and status checked 17 September 2026. Citation date is the last posted registry update, not a results publication.