N/A
Completed N=15
Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
Pre-diabetes
Source: ClinicalTrials.gov NCT03695913 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Participant Satisfaction With Continuous Glucose Monitoring (CGM) — 10; 4; 1; 0 participants
Summary
This study will recruit pre-diabetic patients to see if continuous glucose monitoring (CGM) with a low carbohydrate diet can reduce the percentage of time the CGM readings are above the normal range. Through this study it will demonstrate the feasibility of using CGM with a low carbohydrate diet to reduce weight and risk of developing diabetes in patients with pre-diabetes.
Patients that appear to be eligible will be recruited from Michigan Medicine in the Family Medicine Clinic at the Livonia Center.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Satisfaction With Continuous Glucose Monitoring (CGM) |
10; 4; 1; 0; 0 | — |
| PRIMARY Participant Satisfaction With Continuous Glucose Monitoring |
13; 13 | — |
| SECONDARY Feasibility, Measured by Recruitment |
15 | — |
| SECONDARY Feasibility of Pre-diabetic Patients to Wear CGM Sensors |
15 | — |
| SECONDARY Weight Change |
-1.41 | — |
| SECONDARY Change in Percentage of Time Glucose is Above 140 |
-2.6 | — |
| SECONDARY Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call |
— | — |
| SECONDARY Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log |
1 | — |
| SECONDARY Change in Knowledge of Low Carbohydrate Eating |
.57 | — |
| SECONDARY Change in Cravings From Day 11 to Day 22 |
-.625 | — |
| SECONDARY Intention to Continue Low Carbohydrate Eating |
4.5 | — |
| SECONDARY Utility of CGM Feedback for Changing Diet |
15 | — |
Eligibility Criteria
Inclusion Criteria
- A1C Glucose Measurement between 5.7 to 6.4 (for most recent A1C test, not older than 1 year)
- No diabetes medication including Metformin
- BMI (body mass index) >30
- Must speak, read, and write in English
- No current pregnancy or breastfeeding
- Must not classify as either Vegan or Vegetarian
- Must be a patient at the Livonia Health Center
Exclusion Criteria
- previous bariatric surgery
Data sourced from ClinicalTrials.gov (NCT03695913). 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.