N/A
Completed N=35
CGM Plus GEM in Prediabetes
Source: ClinicalTrials.gov NCT05580978 ↗Enrolled (actual)
35
Serious AEs
3.1%
Results posted
Jun 2026
Primary outcomePrimary: Change in Percentage of CGM Glucose Readings > 120 mg/dL — 25.0; 21.5; 16.9; 21.7 percentage of CGM readings
Summary
This study is designed to look into the effect of a lifestyle management guide called GEM (Glycemic Excursion Minimization) alongside continuous glucose monitoring (CGM) and an activity monitor (FitBit) and the effect this can have on persons with prediabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of CGM Glucose Readings > 120 mg/dL |
25.0; 21.5; 16.9; 21.7 | — |
| SECONDARY Change in HbA1c |
6.2; 6.2; 6.0; 6.1 | — |
| SECONDARY Change in Glucose Variability |
18.6; 18.4; 16.6; 19.2 | — |
| SECONDARY Change in Body Mass Index |
30.7; 30.8; 29.2; 30.3 | — |
| SECONDARY Change in Cardiovascular Risk |
5.6; 5.2; 6.0; 5.1 | — |
| SECONDARY Change in Empowerment |
32.8; 30.4; 36.6; 32.8 | — |
| SECONDARY Change in Depressive Symptoms |
2.6; 3.5; 2.0; 3.2 | — |
| SECONDARY Change in Diabetes Knowledge |
61.9; 62.8; 74.5; 62.8 | — |
| SECONDARY Dietary Habits |
32.5; 29.4; 18.8; 33.8 | — |
| SECONDARY Motivation and Attitudes Toward Changing Health |
4.58; 4.57; 4.57; 4.63 | — |
Eligibility Criteria
Inclusion Criteria
- Age 25-70 years
- A1C 6.0-6.4
- Documented diagnosis of prediabetes
- Have a smart phone
- Able to read English, as the GEM guide is currently only available in English
- Willing and able to follow the study procedures as instructed
Exclusion Criteria
- Diagnosis of diabetes mellitus
- Currently taking any diabetes medication
- Currently taking medication that promotes insulin resistance or otherwise interferes with metabolic control (e.g., prednisone)
- Has a condition that precludes a low carbohydrate diet, such as gastroparesis
- Has a physical or medical condition that precludes walking 120 steps per minute for 10 minutes or longer
- Has documented kidney disease that would preclude participation in study per PI discretion
- Active or planned cancer treatment
- Extreme visual or hearing impairment that would impair ability to use real-time CGM
- Pregnant or anticipates becoming pregnant in the next 4 months
- Anticipates moving within the next 4 months
- Treating physician, for any reason, considers their patient inappropriate for the study (e.g., uncontrolled bipolar disease)
Data sourced from ClinicalTrials.gov (NCT05580978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.