DailyDose app-based decision support with diabetes education
What this study tests
AB-CDE randomizes adults with T1D using multiple daily injections to DailyDose decision support with additional education when indicated, or usual care with the app in data-logging mode. The primary outcome is HbA1c change at 24 weeks.
Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).
Registry checked: 2026-09-17. Registry’s own update: 2026-09-02.
Latest dated source in the citation list: 2026-09-02. 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 for at least one year, multiple daily injections for at least 30 days, and HbA1c or GMI 7.5–11.5%. Participants must use the study insulin and devices and meet additional medical criteria. 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: United States. 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 centrally measured HbA1c from baseline to 24 weeks after randomization.
The full picture
This open-label randomized study plans 99 participants. Both groups use study CGM and insulin-dose capture. The intervention enables DailyDose recommendations, while the control group uses its data-logging mode with usual care. The study provides Dexcom G6, Humalog and Basaglar Tempo pens, an iPhone and an Apple Watch.1
DailyDose combines glucose, insulin, meal and exercise information to recommend insulin adjustments and carbohydrate intake. After the first 12 weeks, intervention participants who meet the protocol’s glucose criteria for extra support receive diabetes self-management education and, when indicated, behavioral-health care. Total participation is planned for 38 weeks, including a two-week run-in.1
HbA1c at 24 weeks is the primary endpoint. HbA1c at 36 weeks, time in range, low-glucose measures and diabetes distress are secondary. Because this evaluates an app plus a care pathway, any future effect cannot automatically be attributed to the app alone.1
The registry lists study start 2026-07-08 (actual), primary completion 2027-07-15 (estimated) and study completion 2027-12-15 (estimated). These dates retain the registry’s actual or estimated labels; an estimated date is not confirmation that an event occurred.1
References
-
ClinicalTrials.gov. NCT07282639. Last update posted 2026-09-02; checked 17 September 2026. https://clinicaltrials.gov/study/NCT07282639 ↩ ↩2 ↩3 ↩4
Sources
- [1]App-Based Certified Diabetes Education Therapy (AB-CDE) (NCT07282639) · Trial registry · 2026-09-02 — Current registered protocol, eligibility, endpoints and status checked 17 September 2026; the citation date records the registry update, not a results publication.