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

NCT07599982 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-05-29

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

DEVICE

MODI Algorithm

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.

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • Abbott Diabetes Care

    collaborator INDUSTRY

  • DreaMed Diabetes

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599982 on ClinicalTrials.gov