NCT03695913

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

Completed NA Results posted Last updated 16 March 2020

What this trial tests

NA trial testing Normal Diet in Pre-diabetes in 15 participants. Completed in 26 September 2019.

Timeline

16 October 2018

Primary endpoint
7 March 2019

26 September 2019

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	16 October 2018
Primary completion	7 March 2019
Estimated completion	26 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Normal Diet
• Low carb diet
• CGM with no real time feedback
• CGM with real time feedback)
• Education material

Conditions studied

• Pre-diabetes — all drugs for Pre-diabetes →

Sponsor

University of Michigan

Who can join

21 and older, any sex, with Pre-diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participant Satisfaction With Continuous Glucose Monitoring (CGM) Primary · 33 days after day 1 (visit 3 completion)

Satisfaction is measured using responses to the post intervention survey question, "How likely are you to recommend that a friend or family member with pre-diabetes wear a continuous glucose monitor (CGM)?". A 5 point scale was used, ranging from 1 to 5, where a score of 1 is "extremely likely" and 5 is "would not recommend". Satisfied respondents answered either 1 or 2 on the scale.

1 - extremely likely

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	10

2 - likely

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	4

3- Neither likely or unlikely

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	1

4 - Not likely

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	0

5 - Would not recommend

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	0

Participant Satisfaction With Continuous Glucose Monitoring Primary · 60 days (30 days after visit 3 completion)

Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.

Respondents perceived no barriers to CGM use

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	13

Respondents attempted the low carb diet

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	13

Feasibility, Measured by Recruitment Secondary · 3 months

Successful recruitment completed within 3 months

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	15

Feasibility of Pre-diabetic Patients to Wear CGM Sensors Secondary · completed within 60 days of enrollment

Feasibility is measured by the number of participants who wore a sensor for at least 20 out of 22 days

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	15

Weight Change Secondary · day 11 (visit 2), day 22 (visit 3)

Change between visit 1 and the final visit.

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	-1.41	± 2.18

Change in Percentage of Time Glucose is Above 140 Secondary · 33 days after day 1

Comparison between the first sensor wear period and the second sensor wear period.

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	-2.6	± 6.5

Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call Secondary · Approximately 5 days each new sensor is placed (days 5 and 16)

During the health check phone call survey, participants were asked to report whether they experienced any side effects.

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	0

Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log Secondary · days 11 through 22

In the patient side effect log, participants recorded whether they experienced any side effects.

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	1

Change in Knowledge of Low Carbohydrate Eating Secondary · baseline, day 22

The Low Carbohydrate Knowledge Scale ranges from 15-41, where 15 is a low score and 41 is a high score. Participants were asked to report knowledge at baseline and completion. A positive score indicates an increase from baseline in knowledge, while a score of 15 indicates no change and a negative score indicates a decrease in knowledge from baseline.

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	.57	± 1.34

Change in Cravings From Day 11 to Day 22 Secondary · 11 days

Participants recorded cravings in food logs. Craving rating scale ranges from 1 to 5, where a score of 1 is low and a score of 5 is high.

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	-.625	± .93

Intention to Continue Low Carbohydrate Eating Secondary · day 22

The completion survey asked participants a question, "How confident are you that you can maintain a low carbohydrate diet for the next 12 months?" Intention to Continue Low Carbohydrate eating used a scale of 1 to 5, where a score of 1 was not confident at all and a score of 5 was very confident.

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	4.5	± .51

Utility of CGM Feedback for Changing Diet Secondary · 60 days (30 days after visit 3 completion)

Utility of CGM feedback is expressed as the number of participants who qualitatively indicated that CGM feedback helped them to change their diet. Themes were identified and coded from qualitative interviews around this topic. Two qualitative coders identified themes that supported this construct.

Group	Value	95% CI
Normal Diet + CGM Then Low Carb + CGM	15

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Normal Diet + CGM Then Low Carb + CGM

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Normal Diet + CGM Then Low…
Bleeding at Insertion site	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03695913 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.