Type 2 diabetes

Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Recruiting · 2 sites across 2 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 Randomized Control Trial (RCT) with 1:1 randomization of adults newly diagnosed with type 2 diabetes (T2D) to Routine Care (RC) and RC + Glycemic Excursion Minimization (RC+GEM); a program that provides RC in addition to continuous glucose monitors (CGM) within a structured, self-directed, and personalized lifestyle program called GEM. Our hypothesis is that RC+GEM will: 1) reduce hemoglobin A1c as much or more, 2) require less diabetes medication, 3) cost less, and 4) have more secondary benefits, (e.g.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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 diagnosed with type 2 diabetes within the past 24 months
•Age 30 to 80 years
•Hemoglobin A1c (a blood test for average blood sugar) at least 6.5% and up to 11% (a recent value from the medical record within 6 months is acceptable)
•Can use a smartphone throughout the study
•Had a diabetes management visit with a medical provider within 12 months of screening
•If using weight-changing medicines (examples given: GLP-1 or GIP), the dose should be stable for about 4 weeks

🚫 You may not be able to join if…

•Use of medications in the last 3 months that, in the study doctors’ judgment, could block weight loss
•Taking any psychotropic medication that, in the study doctors’ judgment, could raise blood glucose
•Severe mental or substance use problems that would make the study hard to do (examples given: manic depressive illness, severe depression, active substance abuse)
•Medical conditions that would make it unsafe or impossible to increase physical activity (examples given: severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
•Conditions that make it impossible to follow the GEM program (examples given: cannot read English; mental health conditions such as active substance abuse or severe depression)
•Diet restrictions that would prevent the study diet from being followed (examples given: severe gastroparesis, ulcers, food allergies)
•Severe vision impairment that would prevent reading the GEM manual or seeing information on the CGM or activity tracker
•Being treated for cancer in a way that the study doctor thinks would prevent participation
•Kidney problems, for example eGFR < 45 mL/min/1.73 m² (CKD-3b)
•Currently pregnant or planning pregnancy within the next 14 months
•Currently breastfeeding

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 30–80
✓Have Type 2 diabetes

!Some conditions may not be a fit: Heart / cardiovascular disease, Kidney disease, COPD (chronic lung 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?+

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 · NCT05766735 · Locations: Colorado · Virginia