N/A
N=35
CGM Plus GEM in Prediabetes
PreDiabetes
Bottom Line
View on ClinicalTrials.gov: NCT05580978 ↗Enrolled (actual)
35
Serious AEs
3.1%
Results posted
Jun 2026
Primary outcome: Primary: Change in Percentage of CGM Glucose Readings > 120 mg/dL — 25.0; 21.5; 16.9; 21.7 percentage of CGM readings
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GEM (Behavioral); Routine Care (Other)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2025
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 | — |
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.
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.