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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults ages 30 to 80 diagnosed with type 2 diabetes in the past 2 years. It compares usual care alone with usual care plus GEM, a self-guided lifestyle program that uses continuous blood sugar monitors to help limit blood sugar rises after meals. The study tests whether adding GEM improves blood sugar, lowers medicine needs and costs, and offers other health benefits.

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. greater reduction in cardiovascular risk, weight, diabetes distress, depression symptoms), compared to RC alone.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 2 diabetes diagnosed within the past 24 months, as confirmed by the study team.
  • Be 30 to 80 years old.
  • Have an A1c of 6.5% to 11%. A1c measures average blood sugar. A medical record result less than 6 months old is allowed.
  • Have access to a smartphone throughout the study.
  • Have had a diabetes care visit with a medical provider within 12 months before screening.
  • If taking medicine that changes weight, such as GLP-1 or GIP medicines, have used a steady dose for about 4 weeks.

Who can't join

  • Have used medicines that make weight loss harder in the past 3 months, or take mental health medicines that may raise blood sugar, as judged by study doctors.
  • Have a condition that prevents study participation or doing GEM on your own, such as severe mental illness, severe depression, or active substance abuse; or cannot read English.
  • Have a condition that prevents more physical activity, such as severe nerve damage, heart disease, serious lung disease, severe joint disease, or stroke.
  • Have a condition that limits your diet, such as severely slowed stomach emptying, ulcers, or food allergies.
  • Have vision loss that the lead study doctor believes prevents reading the GEM guide or seeing monitor or activity tracker information.
  • Are receiving cancer treatment that the lead study doctor believes prevents participation, or have reduced kidney function, such as an eGFR below 45, a measure of kidney filtering.
  • Are pregnant, plan to become pregnant within the next 14 months, or are breastfeeding.
  • Have any other condition that the lead study doctor believes could prevent safe and effective completion of the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria 1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months 2. Age ≥30.0 and ≤80 years 3. Hemoglobin A1c = ≥6.5-≤11% (medical record value \<6 month-old is acceptable) 4. Access to smartphone throughout the study 5. Diabetes management visit with medical provider within 12 months of screening date 6. If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks Exclusion Criteria: 1. Medications that impede weight loss within the last 3 months, per study physicians' discretion 2. Any psychotropic medication that could raise blood glucose, per study physicians' opinion 3. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse) 4. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke) 5. Conditions that prevent doing the self-directed GEM program, such as inability to read English, mental health conditions that prevent engagement in treatment, such as active substance abuse, severe depression 6. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies 7. Severe vision impairment that at PI discretion would preclude ability to read the GEM manual or see the information on the CGM or activity tracker 8. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study 9. Renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b) 10. Currently pregnant or contemplating pregnancy within the next 14 months 11. Currently breastfeeding 12. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.

Study sites (2)

CO

VA