Pre-diabetesNCT03695913
Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
A study testing Normal Diet, Low carb diet and CGM with no real time feedback in people with Pre-diabetes, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Normal Diet, Low carb diet and CGM with no real time feedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 26 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
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
- Being tested
- Normal Diet, Low carb diet, CGM with no real time feedback, CGM with real time feedback), Education material
- Keywords
- Pre-diabetes, low carbohydrate diet
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal DietOther
Phase I (regular diet):
all participants will eat their normal diet and will log their food.
Low carb dietOther
Phase II (low carb diet):
participants will be asked to eat a low carb diet and log their food
CGM with no real time feedbackDevice
Phase I will collect CGM without real time feedback
CGM with real time feedback)Device
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.
Education materialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Diet + CGM then low carb + CGM | Experimental | 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). Receives: Other: Normal Diet; Other: Low carb diet; Device: CGM with no real time feedback; Device: CGM with real time feedback); Behavioral: Education material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 33 days after day 1 (visit 3 completion)
Participant Satisfaction With Continuous Glucose Monitoring
Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.
Measured: 60 days (30 days after visit 3 completion)
Secondary outcomes (10)
Feasibility, Measured by Recruitment
Successful recruitment completed within 3 months
Measured: 3 months
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
Measured: completed within 60 days of enrollment
Weight Change
Change between visit 1 and the final visit.
Measured: day 11 (visit 2), day 22 (visit 3)
Change in Percentage of Time Glucose is Above 140
Comparison between the first sensor wear period and the second sensor wear period.
Measured: 33 days after day 1
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.
Measured: Approximately 5 days each new sensor is placed (days 5 and 16)
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.
Measured: days 11 through 22
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.
Measured: baseline, day 22
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.
Measured: 11 days
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.
Measured: day 22
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.
Measured: 60 days (30 days after visit 3 completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start16 Oct 2018
- Primary completion7 Mar 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Richardson, University of Michigan
- Investigators
- Caroline Richardson, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695913
- Sponsor's protocol ID
- HUM00145667
- Status last verified
- Feb 2020
- First submitted
- 2 Oct 2018
- Last updated
- 16 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
- ClinicalTrials.gov ID
- NCT03695913
- Acronym / sponsor ID
- HUM00145667
- Conditions
- Pre-diabetes
- Keywords
- Pre-diabetes, low carbohydrate diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Diet + CGM then low carb + CGM | Experimental | Other: Normal Diet, Other: Low carb diet, Device: CGM with no real time feedback, Device: CGM with real time feedback), Behavioral: Education materialPhase 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- previous bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal DietPhase I (regular diet): all participants will eat their normal diet and will log their food. | Other | Normal Diet + CGM then low carb + CGM |
| Low carb dietPhase II (low carb diet): participants will be asked to eat a low carb diet and log their food | Other | Normal Diet + CGM then low carb + CGM |
| CGM with no real time feedbackPhase I will collect CGM without real time feedback | Device | Normal Diet + CGM then low carb + CGM |
| 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. | Device | Normal Diet + CGM then low carb + CGM |
| Education materialPhase 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. | Behavioural | Normal Diet + CGM then low carb + CGM |
Primary outcome
Participant Satisfaction With Continuous Glucose Monitoring (CGM)
Time frame: 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
Time frame: 60 days (30 days after visit 3 completion)
Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.
10 secondary outcomes
Feasibility, Measured by Recruitment
Time frame: 3 months
Feasibility of Pre-diabetic Patients to Wear CGM Sensors
Time frame: completed within 60 days of enrollment
Weight Change
Time frame: day 11 (visit 2), day 22 (visit 3)
Change in Percentage of Time Glucose is Above 140
Time frame: 33 days after day 1
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call
Time frame: Approximately 5 days each new sensor is placed (days 5 and 16)
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log
Time frame: days 11 through 22
Change in Knowledge of Low Carbohydrate Eating
Time frame: baseline, day 22
Change in Cravings From Day 11 to Day 22
Time frame: 11 days
Intention to Continue Low Carbohydrate Eating
Time frame: day 22
Utility of CGM Feedback for Changing Diet
Time frame: 60 days (30 days after visit 3 completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Richardson, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Diet, Low carb diet and CGM with no real time feedback in people with Pre-diabetes, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction With Continuous Glucose Monitoring (CGM) (time frame: 33 days after day 1 (visit 3 completion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.