Trial Outcomes & Findings for Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes (NCT NCT03695913)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

33 days after day 1 (visit 3 completion)

Results posted on

2020-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Normal Diet + CGM, Then Low Carb + CGM For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant did not complete the baseline survey

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Age, Continuous	54.6 years STANDARD_DEVIATION 9.08 • n=15 Participants
Sex: Female, Male Female	10 Participants n=15 Participants
Sex: Female, Male Male	5 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	3 Participants n=15 Participants
Race (NIH/OMB) White	11 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=15 Participants
Knowledge of Low Carbohydrate Eating	26.4 score on a scale STANDARD_DEVIATION 1.65 • n=14 Participants • One participant did not complete the baseline survey

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Participant Satisfaction With Continuous Glucose Monitoring (CGM) 1 - extremely likely	10 participants
Participant Satisfaction With Continuous Glucose Monitoring (CGM) 2 - likely	4 participants
Participant Satisfaction With Continuous Glucose Monitoring (CGM) 3- Neither likely or unlikely	1 participants
Participant Satisfaction With Continuous Glucose Monitoring (CGM) 4 - Not likely	0 participants
Participant Satisfaction With Continuous Glucose Monitoring (CGM) 5 - Would not recommend	0 participants

PRIMARY outcome

Timeframe: 60 days (30 days after visit 3 completion)

Population: 2 participants did not participate in the qualitative interview.

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

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=13 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Participant Satisfaction With Continuous Glucose Monitoring Respondents perceived no barriers to CGM use	13 Participants
Participant Satisfaction With Continuous Glucose Monitoring Respondents attempted the low carb diet	13 Participants

SECONDARY outcome

Timeframe: 3 months

Successful recruitment completed within 3 months

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Feasibility, Measured by Recruitment	15 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Feasibility of Pre-diabetic Patients to Wear CGM Sensors	15 Participants

SECONDARY outcome

Timeframe: day 11 (visit 2), day 22 (visit 3)

Change between visit 1 and the final visit.

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Weight Change	-1.41 pounds Standard Deviation 2.18

SECONDARY outcome

Timeframe: 33 days after day 1

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

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=14 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Change in Percentage of Time Glucose is Above 140	-2.6 Percentage of Time Glucose is 140+ Standard Deviation 6.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call	0 Participants

SECONDARY outcome

Timeframe: days 11 through 22

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

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log	1 Participants

SECONDARY outcome

Timeframe: baseline, day 22

Population: One participant did not complete the baseline survey, so change could not be assessed.

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.

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=14 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Change in Knowledge of Low Carbohydrate Eating	.57 score on a scale Standard Deviation 1.34

SECONDARY outcome

Timeframe: 11 days

Population: 10 participants submitted both pre- and post-intervention food logs. Data was unusable for 5 participants because they either did not complete the pre-intervention food log and/or they didn't complete the post-intervention food log

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.

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=10 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Change in Cravings From Day 11 to Day 22	-.625 score on a scale Standard Deviation .93

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Intention to Continue Low Carbohydrate Eating	4.5 score on a scale Standard Deviation .51

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 Participants For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Utility of CGM Feedback for Changing Diet	15 Participants

Adverse Events

Normal Diet + CGM Then Low Carb + CGM

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Normal Diet + CGM Then Low Carb + CGM n=15 participants at risk For 11 days, patients will wear a CGM sensor (with no real time feedback), eat a regular diet, document what they eat on a food log and rate their postprandial fatigue and cravings. Then, for 11 days, patients will eat a low-carb diet, wear a CGM sensor (with real time feedback), document what they eat on a food log, rate their postprandial fatigue and cravings, and document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).
Skin and subcutaneous tissue disorders Bleeding at Insertion site	6.7% 1/15 • 6 months

Additional Information

Spring Stonebraker

University of Michigan

Phone: 734-649-0219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place