102 Participants NeededMy employer runs this trial

MODI Algorithm for Type 1 Diabetes

(MODIUS Trial)

Recruiting at 5 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: DreaMed Diabetes
Must be taking: Injected insulin
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?

This trial tests a new tool called the MODI algorithm, designed to assist people with type 1 diabetes (T1D) who manage their condition with multiple daily insulin injections and continuous glucose monitoring. The researchers aim to determine if the MODI algorithm is safe for this group. The study lasts 13 weeks, following a 2-week period on standard therapy. Ideal participants are adults who have lived with T1D for at least six months, use insulin injections daily, and continuously monitor their glucose levels. Participants must also agree to use specific smartphone apps to record daily activities and insulin use. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management research.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you must stop taking your current medications. However, your doses of non-insulin glucose-lowering and weight loss medications should be stable for 4 weeks before the trial and are not expected to change during the study, unless for safety reasons.

What prior data suggests that this algorithm is safe for adults with type 1 diabetes?

Research has shown that the MODI Algorithm, which helps adjust insulin doses for people with type 1 diabetes, has undergone previous study. These studies suggest it is safe to use. For instance, one study tested a similar digital tool for adjusting insulin in people with type 2 diabetes and found it to be a safe way to manage insulin doses.

Another study demonstrated that automated insulin adjustments provided a safe method for patients, resulting in a small but beneficial reduction in blood sugar levels. This indicates that using technology to manage insulin doses can be a safe option for people with diabetes. Although specific study details for MODI are not available, these findings offer some reassurance about the safety of using algorithms to manage insulin delivery.12345

Why are researchers excited about this trial?

The MODI Algorithm is unique because it offers a personalized approach to managing Type 1 Diabetes by using an advanced algorithm for insulin titration. Unlike standard treatments that often rely on manual adjustments of insulin doses, this algorithm-driven method aims to optimize insulin dosing more efficiently and accurately. Researchers are excited about this treatment because it has the potential to reduce the guesswork in insulin management, potentially leading to better blood sugar control and improved quality of life for patients.

What evidence suggests that the MODI Algorithm is effective for type 1 diabetes?

Research has shown that the MODI Algorithm, which adjusts insulin doses for people with type 1 diabetes, is promising. One study found that using this algorithm increased the time patients maintained their blood sugar within the target range from 64% to 77% and significantly reduced the time they experienced low blood sugar. Another study reported that patients using the MODI Algorithm had an average HbA1c level of 6.58%, with most staying below the target level. These findings suggest that the MODI Algorithm can effectively help manage blood sugar levels in type 1 diabetes. Participants in this trial will receive guidance on insulin titration using the MODI Algorithm.16789

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

Citations

MODY calculator applied in patients with clinical diagnosis of ...

This study aimed to evaluate the mean post-test probability (PTP) of the Maturity-onset diabetes of the young (MODY) calculator in a multiethnic ...

MODI Algorithm for Type 1 Diabetes (MODIUS Trial)

The study tests the safety of MODI, an algorithm that helps adjust insulin doses in people with type 1 diabetes using daily injections and ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32915722/

A Model-Based Insulin Dose Optimization Algorithm for ...

Simulation results showed an improvement in the time in target (3.9-10 mmol/L) from 64% to 77% and a decrease in the time in hypoglycemia (< 3.9 mmol/L) from ...

Maturity-Onset Diabetes of the Young: Rapid Evidence ...

Algorithm for targeted genetic testing for MODY. TYPE 1 DIABETES VS. MODY. The pathogenesis of MODY does not involve pancreatic beta-cell autoimmunity.

The Efficacy of MDI Treatment With an Optimization Algorithm ...

The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal injections and ICRs. The investigators hope that ...

A Digital Health Tool for Insulin Titration (DHIT) Individuals ...

A Digital Health Tool for Insulin Titration (DHIT) for Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group.

Effect of Digital-Tool-Supported Basal Insulin Titration ... - PMC

A real-world pilot study of patients with T2DM that used MDC for BI titration conducted in India, reported that 34% (n = 113) of their patients reached the FBG ...

Device-supported automated basal insulin titration in ...

Automated BI titration may be associated with small benefits in reducing HbA 1c and appears to be a safe strategy for patient self-management in people with ...

Initiation and Titration of Basal Insulin

Achieving fasting glucose targets with basal insulin can lead to a 1-4% or higher reduction in A1C and a reduced risk of diabetes-related ...