Lifestyle program with glucose monitors for newly diagnosed type 2 diabetes

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 30 to 80 who were diagnosed with type 2 diabetes in the past 24 months and have a smartphone.

Age

30 to 80 years

Sex

All sexes can join.

Disease stage

Type 2 diabetes diagnosed within the past 24 months, with hemoglobin A1c from 6.5% (48 mmol/mol) to 11% (97 mmol/mol).

Earlier treatment

Must have seen a medical provider about diabetes within 12 months before screening. If taking weight-altering medicines such as GLP-1 or GIP, the dose must be stable for about four weeks.

Biomarker or test result

Hemoglobin A1c from 6.5% (48 mmol/mol) to 11% (97 mmol/mol) (a medical record value less than 6 months old is accepted).

Main reasons for not taking part

• Medicines that make weight loss harder in the last 3 months
• Kidney problems (for example eGFR below 45 mL/min/1.73 meters squared)
• Currently pregnant, planning pregnancy within the next 14 months, or breastfeeding
• Conditions that prevent more physical activity or a restricted diet
• Cannot read English, or severe vision problems that prevent using the program materials

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 30 and 80 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• Routine Care (RC)Existing treatment, for comparison

  Participants will be actively working with their primary care provider during the study and will attend appointments with their provider as needed. The study team will monitor their progress at the scheduled Assessment Visits. The participants should discuss any concerns they have, including side effects or cost, in order to adjust the medication regime with their primary care team. Their physician/clinician may recommend additional things, like weight loss, exercise programs and/or diabetes education programs.

• Routine Care + Glucose Excursion Minimization (RC+GEM)Treatment being tested

  Participants will actively work with their primary care provider and receive personalized routine care (RC). In addition, participants will receive GEM, an individualized, person-centered, empowerment program, not a behavior modification program. GEM provides individuals with personally relevant information to make choices that will help them achieve their diabetes goals. It focuses on techniques - eating low glycemic load foods, increasing moderate and vigorous exercise, and monitoring blood glucose (BG) to educate individuals about the impact of high glycemic load nutrients and vigorous exercise. The emphasis is on minimizing glucose excursions by any practical means, e.g., nutrient selection, timing and combinations of nutrient intake, time restricted eating, eating carbohydrates after protein and fat, post prandial physical activity, whatever is personally affirmed by BG feedback.

  Treatment: Routine Care + Glycemic Excursion Minimization (RC+GEM)