Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes

Part of paid clinical trials in Albany, New York.

Sponsor
DreaMed Diabetes
Study ID
NCT07599982
Status
Recruiting
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Conditions

  • Type 1 Diabetes (T1D)
  • Type 2 Diabetes (T2D)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • MODI Algorithm — DEVICE
    All participants use MODI insulin titration algorithm. Includes Diary app used to view treatment plans shared by MODI and manually log events (insulin intake, meal, physical activity and others) by participants; also includes a bolus calculator.

Study Details

A 13-week multi-center single-arm trial, preceded by a 2-week standard therapy phase, will be conducted to assess the safety of MODI, an insulin titration algorithm, in adults with type 1 diabetes (T1D) who use multiple daily insulin injections (MDI), or with type 2 diabetes (T2D) who use MDI, basal insulin only, or who are candidates to initiate basal insulin, in conjunction with continuous glucose monitoring (CGM).

Key Dates

Start date
May 25, 2026
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MODI dose guidance, insulin titration application

Primary Outcome Measure

CGM-measured percent time <54mg/dL [ Time Frame: 13 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
SUNY Upstate Medical CenterAlbanyNew York12246
Suzan Bzdick, RN, CDCES, CCRC
[email protected]
315-464-9006
Malek El Muayed, MD (PRINCIPAL_INVESTIGATOR)
Texas Diabetes & EndocrinologyAustinTexas78731
Thomas Blevins, MD
[email protected]
512-458-8400
Thomas Blevins, MD (PRINCIPAL_INVESTIGATOR)
Diabetes & Endocrine Treatment Specialisits (DETS)Sandy CityUtah84093
Ryan Luker, RN
[email protected]
801-816-1010
Timothy Graham, MD (PRINCIPAL_INVESTIGATOR)

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SUNY Upstate Medical Center· Albany, NYTexas Diabetes & Endocrinology· Austin, TXDiabetes & Endocrine Treatment Specialisits (DETS)· Sandy City, UT

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