Pre-diabetes
Conditions
Keywords
Pre-diabetes, low carbohydrate diet
Brief 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.
Interventions
OTHERNormal Diet
Phase I (regular diet): all participants will eat their normal diet and will log their food.
OTHERLow carb diet
Phase II (low carb diet): participants will be asked to eat a low carb diet and log their food
DEVICECGM with no real time feedback
Phase I will collect CGM without real time feedback
DEVICECGM 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.
BEHAVIORALEducation 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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With Continuous Glucose Monitoring (CGM) | 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. |
| Participant Satisfaction With Continuous Glucose Monitoring | 60 days (30 days after visit 3 completion) | Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | day 11 (visit 2), day 22 (visit 3) | Change between visit 1 and the final visit. |
| Change in Percentage of Time Glucose is Above 140 | 33 days after day 1 | Comparison between the first sensor wear period and the second sensor wear period. |
| Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call | 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. |
| Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log | days 11 through 22 | In the patient side effect log, participants recorded whether they experienced any side effects. |
| Feasibility, Measured by Recruitment | 3 months | Successful recruitment completed within 3 months |
| Change in Cravings From Day 11 to Day 22 | 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. |
| Intention to Continue Low Carbohydrate Eating | 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. |
| Utility of CGM Feedback for Changing Diet | 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. |
| Change in Knowledge of Low Carbohydrate Eating | 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. |
| Feasibility of Pre-diabetic Patients to Wear CGM Sensors | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Normal Diet + CGM Then Low Carb + CGM |
|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 9.08 |
| Knowledge of Low Carbohydrate Eating | 26.4 score on a scale STANDARD_DEVIATION 1.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Participant Satisfaction With Continuous Glucose Monitoring
Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.
Time frame: 60 days (30 days after visit 3 completion)
Population: 2 participants did not participate in the qualitative interview.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Participant Satisfaction With Continuous Glucose Monitoring | Respondents perceived no barriers to CGM use | 13 Participants |
| Normal Diet + CGM Then Low Carb + CGM | Participant Satisfaction With Continuous Glucose Monitoring | Respondents attempted the low carb diet | 13 Participants |
Primary
Participant Satisfaction With Continuous Glucose Monitoring (CGM)
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.
Time frame: 33 days after day 1 (visit 3 completion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Participant Satisfaction With Continuous Glucose Monitoring (CGM) | 1 - extremely likely | 10 participants |
| Normal Diet + CGM Then Low Carb + CGM | Participant Satisfaction With Continuous Glucose Monitoring (CGM) | 2 - likely | 4 participants |
| Normal Diet + CGM Then Low Carb + CGM | Participant Satisfaction With Continuous Glucose Monitoring (CGM) | 3- Neither likely or unlikely | 1 participants |
| Normal Diet + CGM Then Low Carb + CGM | Participant Satisfaction With Continuous Glucose Monitoring (CGM) | 4 - Not likely | 0 participants |
| Normal Diet + CGM Then Low Carb + CGM | Participant Satisfaction With Continuous Glucose Monitoring (CGM) | 5 - Would not recommend | 0 participants |
Secondary
Change in Cravings From Day 11 to Day 22
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Change in Cravings From Day 11 to Day 22 | -.625 score on a scale | Standard Deviation 0.93 |
Secondary
Change in Knowledge of Low Carbohydrate Eating
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.
Time frame: baseline, day 22
Population: One participant did not complete the baseline survey, so change could not be assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Change in Knowledge of Low Carbohydrate Eating | .57 score on a scale | Standard Deviation 1.34 |
Secondary
Change in Percentage of Time Glucose is Above 140
Comparison between the first sensor wear period and the second sensor wear period.
Time frame: 33 days after day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Change in Percentage of Time Glucose is Above 140 | -2.6 Percentage of Time Glucose is 140+ | Standard Deviation 6.5 |
Secondary
Feasibility, Measured by Recruitment
Successful recruitment completed within 3 months
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Feasibility, Measured by Recruitment | 15 Participants |
Secondary
Feasibility of Pre-diabetic Patients to Wear CGM Sensors
Feasibility is measured by the number of participants who wore a sensor for at least 20 out of 22 days
Time frame: completed within 60 days of enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Feasibility of Pre-diabetic Patients to Wear CGM Sensors | 15 Participants |
Secondary
Intention to Continue Low Carbohydrate Eating
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.
Time frame: day 22
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Intention to Continue Low Carbohydrate Eating | 4.5 score on a scale | Standard Deviation 0.51 |
Secondary
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call
During the health check phone call survey, participants were asked to report whether they experienced any side effects.
Time frame: Approximately 5 days each new sensor is placed (days 5 and 16)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call | 0 Participants |
Secondary
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log
In the patient side effect log, participants recorded whether they experienced any side effects.
Time frame: days 11 through 22
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log | 1 Participants |
Secondary
Utility of CGM Feedback for Changing Diet
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.
Time frame: 60 days (30 days after visit 3 completion)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Utility of CGM Feedback for Changing Diet | 15 Participants |
Secondary
Weight Change
Change between visit 1 and the final visit.
Time frame: day 11 (visit 2), day 22 (visit 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Diet + CGM Then Low Carb + CGM | Weight Change | -1.41 pounds | Standard Deviation 2.18 |