MODI insulin titration for adults using injections
What this study tests
A single-arm study evaluates DreaMed’s MODI insulin-dose guidance in adults with type 1 or type 2 diabetes. Its primary safety question concerns time spent below 54 mg/dL (3.0 mmol/L), not a demonstrated improvement in glucose control.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-08-28.
Most recent recorded citation date: 2026-08-28. 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 18–80 with T1D or T2D for at least six months and HbA1c above 7.5% and below 12%. T1D participants must use multiple daily injections for at least three months and one daily basal injection for at least one week. Recent pump use is excluded; other 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: 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 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 below 54 mg/dL (3.0 mmol/L) from two baseline weeks to the four weeks preceding the dose-guidance week-12 visit; registered noninferiority margin 0.5 percentage points, overall time frame 13 weeks.
The full picture
The study plans 102 participants, all receiving MODI guidance. The Diary app displays treatment plans and records insulin, meals and activity; it also includes a bolus calculator. Participants use FreeStyle Libre 3. This is guidance for injected insulin, not an automated insulin-delivery pump trial.1
Eligibility differs by diabetes type: T1D participants already use basal-bolus injections, while T2D cohorts may start basal insulin or already use basal-only or multiple-injection treatment. A combined study result would therefore need its population and subgroup denominators stated.1
The primary endpoint tests whether time below 54 mg/dL (3.0 mmol/L) worsens beyond a prespecified 0.5-percentage-point noninferiority margin. HbA1c change is secondary. These are analysis plans; no safety or efficacy result is posted.1
The registry lists study start 2026-05-25 (actual), primary completion 2027-01 (estimated) and study completion 2027-01 (estimated). These dates retain the registry’s actual or estimated labels; an estimated date is not confirmation that an event occurred.1
Sources
- [1]Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes (NCT07599982) · 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.
ClinicalTrials.gov. NCT07599982. Last update posted 2026-08-28; checked 17 September 2026.