CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Normal Diet +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03695913
NCT03695913N/ACompleted

Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes

University of Michigan·interventional·Posted Oct 4, 2018·Updated Mar 16, 2020

In Brief

A clinical study evaluating Normal Diet, Low carb diet, and 3 other interventions for Pre-diabetes. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-diabetes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 4, 2018
Enrollment StartOct 16, 2018
Primary CompletionMar 7, 2019
Study CompletionSep 26, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.7 years ago

Interventions

Normal Dietother

Phase I (regular diet): all participants will eat their normal diet and will log their food.

Low carb dietother

Phase II (low carb diet): participants will be asked to eat a low carb diet and log their food

CGM with no real time feedbackdevice

Phase I will collect CGM without real time feedback

CGM with real time feedback)device

Phase II participants will be asked to scan their sensor at least every eight hours and document their blood sugar before and two hours after eating as well as before breakfast and before going to bed.

Education materialbehavioral

Phase I: participants will be given the book Always Hungry and be asked to read chapters 1-5 after a health check phone call approximately 5 days after the sensor is placed. Phase II: participants will be taught about carbohydrates and the benefits and side effects. Additionally, they will be given multiple resources to assist them regarding carbohydrates as well as a book entitled "The Calorie King, Calories, Fat, and Carbohydrates." Groceries will also be delivered for 2 recipes that the participants choose from to make.