Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes
Recruiting · 3 sites across 3 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is 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).
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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).
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults age 18 to 80 with type 1 or type 2 diabetes for at least 6 months
- •Using insulin in a required pattern: type 1 diabetes using multiple daily injections (MDI) and taking 1 basal insulin shot per day for at least 1 week; or type 2 diabetes using a specified insulin plan (no insulin for 3 months and starting basal-only, or basal-only for 3 months, or MDI for 3 months)
- •HbA1c (a blood sugar average test) greater than 7.5% and less than 12% at screening
- •Using specific injected insulin types listed in the MODI Instructions for Use
- •Willing to use the FSL 3 System CGM (and not use other personal CGMs), use the study mobile app, and follow study instructions
🚫 You may not be able to join if…
- •Used an insulin pump within 3 months before consent
- •Used mixed insulin or NPH within the past 3 months (NPH is a type of insulin)
- •Takes too much insulin: more than 128 units of basal insulin per day, or more than 79 units in a single bolus injection within 7 days before screening
- •Has unstable or unsafe medical problems (for example unstable cardiac disease, unstable or end-stage renal disease, or eating disorders like anorexia/bulimia)
- •Recent serious diabetes emergencies or severe low blood sugar: more than 1 severe hypoglycemic event in 6 months, or DKA/HHS (diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome) in 6 months
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–80
- !Some conditions may not be a fit: Heart / cardiovascular disease
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
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).
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07599982 · Locations: New York · Texas · Utah