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.
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
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
- 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
- Not yet recruiting
Baltimore VA Medical Center Univ of Maryland
Baltimore, Maryland, 21201
Illias Spanakis, MD, 410-605-7000 ext. 57394, ispanakis@som.umaryland.edu
- 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
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).
- Conditions
- Type 1 Diabetes (T1D), Type 2 Diabetes (T2D)
- 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 group | Role | What they receive |
|---|---|---|
| MODI dose guidance, insulin titration application | Experimental | Not described Receives: Device: MODI Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted20 May 2026
- Study start25 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- DreaMed Diabetes
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research, Abbott Diabetes Care
- Responsible party
- Sponsor
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