NCT03695913

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
OTHER	Normal Diet	Phase I (regular diet): all participants will eat their normal diet and will log their food.
OTHER	Low carb diet	Phase II (low carb diet): participants will be asked to eat a low carb diet and log their food
DEVICE	CGM with no real time feedback	Phase I will collect CGM without real time feedback
DEVICE	CGM with real time feedback)	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.
BEHAVIORAL	Education material	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.

Timeline

• Start date: 2018-10-16
• Primary completion: 2019-03-07
• Completion: 2019-09-26
• First posted: 2018-10-04
• Last updated: 2020-03-16
• Results posted: 2020-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study