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Type 1 Diabetes (T1D)MODIUSNCT07599982

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

A study testing MODI Algorithm in people with Type 1 Diabetes (T1D) and Type 2 Diabetes (T2D), run by DreaMed Diabetes at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 1 Diabetes (T1D), Type 2 Diabetes (T2D)
What is being tested?
MODI Algorithm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
6 sitesUnited States
Study dates
25 May 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent
  • Insulin therapy as follows:
  • If T1D, using MDI insulin therapy for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) meal-size-based dosing (small, normal, large); and taking
  • 1 basal insulin injection per day for at least 1 week prior to screening
  • If T2D, either:
  • not using insulin in the 3 months prior to screening, but require initiation of a basal-only insulin regimen based on investigator assessment ii. using only basal insulin for at least 3 months prior to screening and taking 1 basal insulin injection per day for at least 1 week prior to screening iii. using MDI for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either
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  • time-of-day-based dosing (breakfast, lunch, dinner) or (b) mealsize-based dosing (small, normal, large); and taking 1 basal insulin injection per day for at least 1 week prior to screening
  • Age at time of consent 18-80 years
  • HbA1c >7.5% and <12% as measured by point-of-care device or local lab at the time of screening
  • Using only injected insulin types that are specified in the MODI Instructions for Use materials
  • Stable doses of non-insulin glucose lowering medications over the 4 weeks preceding screening as determined by Investigator and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons
  • Stable doses of weight loss medications that may have a meaningful effect on glycemic control over the 4 weeks preceding screening and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons
  • Weight between 80 - 440 lb at the time of screening
  • 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
  • Willing to document insulin delivery, meals, and daily activities in the Diary mobile app
  • Has a smartphone compatible with study requirements: either iOS version 17.0 or higher, or Android version 10.0 or higher, and willing to install required apps and use them as instructed during the period of study participation, with internet connectivity for a data upload at least once per day.
  • Is deemed an appropriate candidate for automatic insulin guidance therapy per Investigator assessment
  • Investigator has confidence that the participant has the cognitive ability necessary for study participation, can successfully operate all study devices, and can adhere to the protocol
  • Has a sufficient understanding of written/spoken English for legally effective informed consent and successful use of the study mobile apps
  • If woman of childbearing potential, is willing and able to have pregnancy testing

Who cannot join

  • Use of an insulin pump within 3 months prior to informed consent
  • Use of mixed insulin or intermediate insulin (NPH) within the past 3 months prior to screening
  • Taking more than 128 units of daily basal insulin or more than 79 units in a single bolus insulin injection in the 7 days prior to screening
  • Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
  • Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
  • Any planned surgery during the study which could be considered major in the judgment of the investigator
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  • History of more than 1 severe hypoglycemic event in the 6 months prior to screening
  • History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening
  • Blood disorder or dyscrasia within 3 months prior to screening which in the investigator's opinion could interfere with determination of HbA1c
  • Any condition or intervention that may affect red blood cell turnover, in the 3 months prior to the study and during the study, such as blood transfusion or donation
  • Has taken oral or injectable corticosteroids within 2 weeks prior to screening or plans to take oral or injectable corticosteroids during the study
  • Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment
  • Is an employee of DreaMed Diabetes, is a study Investigator or a member of the Investigator's study team, or is immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned
  • Participation in another clinical study using an investigational drug or device in the 90 days prior to screening or intends to participate during the study period
  • Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months postmenopausal)
  • Unable to tolerate adhesive tape or has any unresolved skin condition that could impact the CGM sensor

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

United States6 sites, 6 recruiting

  • SUNY Upstate Medical Center

    Albany, New York, 12246

    Suzan Bzdick, RN, CDCES, CCRC, 315-464-9006, BzdickS@upstate.edu

    Malek El Muayed, MD

    Recruiting

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

    Thomas Blevins, MD, 512-458-8400, Thomas.blevins@texasdiabetes.com

    Thomas Blevins, MD

    Recruiting

  • Baltimore VA Medical Center Univ of Maryland

    Baltimore, Maryland, 21201

    Illias Spanakis, MD, 410-605-7000 ext. 57394, ispanakis@som.umaryland.edu

    Not yet recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Davida Kruger, 313-916-3906, dkruger1@hfhs.org

    Davida Kruger

    Recruiting

  • Centricity Research - Morehead City

    Morehead City, North Carolina, 28557

    Ku-Lang Chang, MD, 252-222-5700, ku-lang.chang@centricityresearch.com

    Recruiting

  • Diabetes & Endocrine Treatment Specialisits (DETS)

    Sandy City, Utah, 84093

    Ryan Luker, RN, 801-816-1010, ryan@DETSutah.com

    Timothy Graham, MD

    Recruiting

Other trials in United States

About this study

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).

Being tested
MODI Algorithm
Keywords
type 1 diabetes, insulin, titration, algorithm, adults, continuous glucose monitoring, multiple daily injections, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MODI AlgorithmDevice

    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 groups in NCT07599982
Study groupRoleWhat they receive
MODI dose guidance, insulin titration applicationExperimentalNot described
Receives: Device: MODI Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CGM-measured percent time <54mg/dL

    Change in CGM-measured percent time <54 mg/dL from 2 weeks of baseline to 4 weeks prior to the dose guidance week 12 visit (non-inferiority with margin 0.5%)

    Measured: 13 weeks

Secondary outcomes (1)

  1. HbA1c

    Change in HbA1c from baseline to dose guidance week 12 visit

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study start25 May 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07599982
Sponsor's protocol ID
CL-1644
Acronym
MODIUS
Status last verified
May 2026
First submitted
14 May 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MODI Algorithm in people with Type 1 Diabetes (T1D) and Type 2 Diabetes (T2D), run by DreaMed Diabetes at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CGM-measured percent time <54mg/dL (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07599982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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