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MODI Algorithm for Type 1 Diabetes

(MODIUS Trial)

Not yet recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: DreaMed Diabetes
Must be taking: Injected insulin
Must not be taking: Mixed insulin, Corticosteroids
Disqualifiers: Insulin pump use, Coronary artery disease, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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) in conjunction with continuous glucose monitoring (CGM).

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with type 1 diabetes for at least 6 months, who use multiple daily insulin injections and a specific continuous glucose monitor. Participants must have moderately high blood sugar (HbA1c between 7.5% and 12%), stable medication doses, weigh between 80–440 lbs, and be willing to track their insulin, meals, and activities.

Inclusion Criteria

4. HbA1c \>7.5% and \<12% as measured by point-of-care device or local lab at the time of screening
8. Weight between 80 - 440 lb at the time of screening
9. Willing to use FSL 3 System according to manufacturer instructions and to avoid use of any other personal CGM system during the period of study participation
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Standard Therapy

Participants undergo a 2-week standard therapy phase before starting the MODI algorithm

2 weeks

Treatment

Participants receive the MODI insulin titration algorithm for 13 weeks

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MODI Algorithm

Trial Overview

The study tests the safety of MODI, an algorithm that helps adjust insulin doses in people with type 1 diabetes using daily injections and continuous glucose monitoring. All participants will use the MODI system over a period of about three months after a short standard therapy phase.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MODI dose guidance, insulin titration applicationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

DreaMed Diabetes

Lead Sponsor

Trials
4
Recruited
340+

Jaeb Center for Health Research

Collaborator

Trials
162
Recruited
36,200+

Abbott Diabetes Care

Industry Sponsor

Trials
67
Recruited
25,600+

Robert B. Ford

Abbott Diabetes Care

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Dr. Mahmood Kazemi

Abbott Diabetes Care

Chief Medical Officer

Bachelor's and Master's degrees from Stanford University, MD from the University of California, San Francisco

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