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

University of Michigan

Status: Completed

Conditions: Pre-diabetes

Treatments: Behavioral: Education material; Other: Normal Diet; Device: CGM with no real time feedback; Other: Low carb diet; Device: CGM with real time feedback)

Study type: Interventional

Funder types: Other

Identifiers

NCT03695913

HUM00145667

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Normal Diet + CGM then low carb + CGM

Experimental group

Description:

Phase I (part 1) - regular diet: Patients will wear a CGM sensor (with no real time feedback) for 11 days; document what they eat on a food log; and rate their postprandial fatigue and cravings. Phase II (part 2) - low carb diet: Patients will wear a CGM sensor (with real time feedback) for 11 days; document what they eat on a food log; and rate their postprandial fatigue and cravings; document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).

Treatment:

Device: CGM with no real time feedback

Other: Low carb diet

Other: Normal Diet

Behavioral: Education material

Device: CGM with real time feedback)