DiabetesNCT04102657
Blood Glucose Differences Between Left Arm and Right Arm Using a Continuous Glucose Monitor
A study testing Intermittent Fasting, Free-Living Diet and Left Arm Exercise in people with Diabetes, run by University of the Pacific at 1 site in United States.
Trial summary
Interest in continuous glucose monitors (CGMs) is growing for use in evaluating real time glucose levels and in detecting extreme high and low values. A CGM is a small device primarily placed on the patient's upper arm or abdomen to measure glucose at frequent time intervals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Intermittent Fasting, Free-Living Diet and Left Arm Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18-65 years of age
- Willing to wear CGM device for 12-14 days on both arms
- Have active health insurance
- Willing to refrain from any heat therapy for the duration of the study
- Having an interest to comply with the fasting requirements of the study as appropriate
- Willingness to maintain once daily email responses
Who cannot join
- Any active dermatologic condition on the upper arms
- Implanted medical devices (i.e. pacemaker)
- Critically ill or dialysis patients
- Planned magnetic resonance imaging screening, computed tomography scan, x-ray imaging or high-frequency electrical heat treatment during study period
- Current systemic infections
- Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
Show all 17Show fewer
- Refusal to sign the informed consent document
- Pregnant, planned-pregnancy in the next 30 days, or breast-feeding
- Active eating disorder
- Taking any medications that have an increased risk of hypoglycemia (e.g. sulfonylureas, insulin, thiazolidinediones) as determined by the primary investigators
- Taking medications for obesity
- You have one of the following medical conditions that can cause rapid weight loss: rheumatoid arthritis, hyperthyroidism, irritable bowel syndrome, cancer, HIV, active tuberculosis, Addison's disease
- In an active weight loss program
- On a specialized diet (e.g. Weight Watchers, ketogenic diet, Atkins diet)
- Completed a specialized diet in the past 2 weeks (e.g. Weight Watchers, ketogenic diet, Atkins diet)
- History of adverse events (i.e. shaking, dizziness, fatigue, fainting) during any prior fasting experience
- Below the age of 18 years and above the age of 65 years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of the Pacific
Stockton, California, 95211
Essie Liu, PharmD, 707-423-3277, xliu2@pacific.edu
Sonoko Kawakatsu, PharmD, 7074233277, skawakatsu@pacific.edu
About this study
Official title: Blood Glucose Differences Between Left Arm and Right Arm Using a Continuous Glucose
Interest in continuous glucose monitors (CGMs) is growing for use in evaluating real time glucose levels and in detecting extreme high and low values. A CGM is a small device primarily placed on the patient's upper arm or abdomen to measure glucose at frequent time intervals. While the accuracy of these devices is researched extensively, there are no large-scale studies evaluating the differences in the right and left arm in terms of device placement. In addition, intermittent fasting has gained popularity due to potential health benefits including reductions in weight, cholesterol, and blood glucose. However, there remains a shortage of studies researching the effect of short-term intermittent fasting on body fat.
The purpose of this study is to see if there is a difference between glucose levels in the right arm and left arm and to examine if short-term intermittent fasting may impact an individual's body fat percentage.
Read the detailed description
Continuous glucose monitoring (CGM) is an emerging field for diabetes management. CGM allows providers to individualize therapy by looking at real time glucose levels, detect changes in blood glucose and raise awareness for hypo- and hyperglycemic events.[1] Some CGM devices can be placed on the patient's arm to monitor blood glucose every few minutes. The data is then sent to a monitor for visualization. There are multiple Food and Drug Administration (FDA)- approved devices for continuous glucose monitoring. The FDA considers a device to be accurate if 99% of blood glucose measurements are within 20% of lab results and if 95% of blood glucose measurements are within 15% of lab results.[2]
The accuracy and precision of CGM devices is improving with several products gaining FDA approval. CGM data has been deemed accurate for self-use to adjusted insulin dosage, detection of hypoglycemia and determining the clinical response to therapy. However, events of low glucose readings and false alarms have been reported.[3]
An analysis conducted of the reports to the FDA Manufacturer and User Facility Device Experience (MAUDE) database since 2015 revealed over 25,000 complaints of CGM device inaccuracy.[4] Although CGM devices are researched extensively, there are no studies confirming that the measurements amongst the right arm and left arm are the same.
Intermittent fasting is an eating pattern in which individuals alternate between a period (~16 or more hours) of eliminated or restricted food intake, and a period of normal food intake. It has gained popularity in the public due to proposed health benefits including reductions in weight, cholesterol, and blood glucose.[6] There is published evidence that suggests beneficial effects of intermittent fasting on body fat. In an 8-week study, a significant decrease in fat mass was observed in the intermittent fasting group compared to the free-living group (-16.4 vs -2.8%).[8] However, this is the only human study assessing time-restrictive intermittent fasting and its effects on body fat, and there remains a shortage of high-quality evidence. We would like to further expand existing research by assessing the effect of short-term intermittent fasting on body fat.
This study is a controlled, prospective trial that aims to evaluate the difference in glucose readings between the right arm and left arm using continuous glucose monitors. In addition this study aims to evaluate the difference in percent body fat between short-term intermittent fasting and a free-living diet. Subjects will follow their designated diet for 12-14 days. The study will assess any changes in glucose levels, body fat percent, body mass index (BMI), weight, body composition before and after this 12-14 day study.
- Conditions
- Diabetes
- Being tested
- Intermittent Fasting, Free-Living Diet, Left Arm Exercise, Right Arm Exercise
- Keywords
- CGM, Glucose Monitoring, Intermittent Fasting, Fasting, Exercise
- Medical subject headings
- Diabetes Mellitus, Intermittent Fasting, Fasting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingOther
Participants will be instructed to limit their daily food consumption to an 8-hour period in the day of their choosing. For the 16-hour fasting period, subjects are to eliminate caloric intake.
Free-Living DietOther
Participants will maintain their current daily food consumption with no caloric restriction. Patient must not have participated in a specialized diet or weight loss program within 2 weeks of enrollment.
Left Arm ExerciseOther
Participants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the left arm. In the middle of the study, participants will switch to the right arm to complete their unilateral arm exercises.
Right Arm ExerciseOther
Participants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the right arm. In the middle of the study, participants will switch to the left arm to complete their unilateral arm exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting with Left Arm Exercise | Experimental | Healthy volunteers willing to fast for a 16-hour period daily for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily. Receives: Other: Intermittent Fasting; Other: Left Arm Exercise |
| Intermittent Fasting with Right Arm Exercise | Experimental | Healthy volunteers willing to fast for a 16-hour period daily for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily. Receives: Other: Intermittent Fasting; Other: Right Arm Exercise |
| Free-living Diet with Left Arm Exercise | Experimental | Healthy volunteers maintaining their current diet for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily. Receives: Other: Free-Living Diet; Other: Left Arm Exercise |
| Free-living Diet with Right Arm Exercise | Experimental | Healthy volunteers maintaining their current diet for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily. Receives: Other: Free-Living Diet; Other: Right Arm Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in time-matched glucose levels between the right arm and left arm
Measured: 12-14 days
Difference in body-fat percentage before and after 12-14 days of designated diet
Measured: 12-14 days
Secondary outcomes (14)
Difference in glucose readings between the right arm and left arm before and after 20-minutes of unilateral arm exercise
Measured: 12-14 days
Difference in glucose readings between the right arm and left arm per designated diet
Measured: 12-14 days
Change in Body Mass Index before and after 12-14 days of designated diet
Measured: 12-14 days
Change in Body Fat Analysis before and after 12-14 days of designated diet
Measured: 12-14 days
Difference in percent of total glucose readings in hypoglycemic range (Interstitial BG <70mg/dL) between the right arm and left arm
Measured: 12-14 days
Difference in percent of total glucose readings in euglycemic range (Interstitial BG 70mg/dL-180mg/dL) between the right arm and left arm
Measured: 12-14 days
Difference in percent of total glucose readings in hyperglycemic range (Interstitial BG >180mg/dL) between the right arm and left arm
Measured: 12-14 days
Difference in percent of total glucose readings in hypoglycemic range (Interstitial BG <70mg/dL) between designated diet groups
Measured: 12-14 days
Difference in percent of total glucose readings in euglycemic range (Interstitial BG 70mg/dL-180mg/dL) between designated diet groups
Measured: 12-14 days
Difference in percent of total glucose readings in hyperglycemic range (Interstitial BG >180mg/dL) between designated diet groups
Measured: 12-14 days
Time in range (Interstitial BG 70mg/dL-180mg/dL) between the right arm and left arm
Measured: 12-14 days
Time below range (Interstitial BG <70 mg/dL) between the right arm and left arm
Measured: 12-14 days
Time in range (Interstitial BG 70mg/dL-180mg/dL) between designated diet groups
Measured: 12-14 days
Time below range (Interstitial BG <70 mg/dL) between designated diet groups
Measured: 12-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start20 Sep 2019
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102657
- Sponsor's protocol ID
- 20-04
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
2. Food and Drug Administration. Self-monitoring blood glucose test systems for over-the-counter use-guidance for industry and food and drug administration staff. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf. Accessed October 10, 2016.
1. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D: The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care 2009;32:1378-1383
Rodbard D. Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities. Diabetes Technol Ther. 2016 Feb;18 Suppl 2(Suppl 2):S3-S13. doi: 10.1089/dia.2015.0417.
PubMed 26784127Shapiro AR. Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe? J Diabetes Sci Technol. 2017 Jul;11(4):833-838. doi: 10.1177/1932296816688303. Epub 2017 Mar 1.
PubMed 28540756Stote KS, Baer DJ, Spears K, Paul DR, Harris GK, Rumpler WV, Strycula P, Najjar SS, Ferrucci L, Ingram DK, Longo DL, Mattson MP. A controlled trial of reduced meal frequency without caloric restriction in healthy, normal-weight, middle-aged adults. Am J Clin Nutr. 2007 Apr;85(4):981-8. doi: 10.1093/ajcn/85.4.981.
PubMed 17413096Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.
PubMed 27737674Kawakatsu S, Liu X, Tran B, Tran BP, Manzanero L, Shih E, Shek A, Lim JJ. Differences in Glucose Readings Between Right Arm and Left Arm Using a Continuous Glucose Monitor. J Diabetes Sci Technol. 2022 Sep;16(5):1183-1189. doi: 10.1177/19322968211008838. Epub 2021 May 6.
PubMed 33955249
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Differences Between Left Arm and Right Arm Using a Continuous Glucose
- ClinicalTrials.gov ID
- NCT04102657
- Acronym / sponsor ID
- 20-04
- Conditions
- Diabetes
- Keywords
- CGM, Glucose Monitoring, Intermittent Fasting, Fasting, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interest in continuous glucose monitors (CGMs) is growing for use in evaluating real time glucose levels and in detecting extreme high and low values. A CGM is a small device primarily placed on the patient's upper arm or abdomen to measure glucose at frequent time intervals. While the accuracy of these devices is researched extensively, there are no large-scale studies evaluating the differences in the right and left arm in terms of device placement. In addition, intermittent fasting has gained popularity due to potential health benefits including reductions in weight, cholesterol, and blood glucose. However, there remains a shortage of studies researching the effect of short-term intermittent fasting on body fat.
The purpose of this study is to see if there is a difference between glucose levels in the right arm and left arm and to examine if short-term intermittent fasting may impact an individual's body fat percentage.
Detailed description
Continuous glucose monitoring (CGM) is an emerging field for diabetes management. CGM allows providers to individualize therapy by looking at real time glucose levels, detect changes in blood glucose and raise awareness for hypo- and hyperglycemic events.[1] Some CGM devices can be placed on the patient's arm to monitor blood glucose every few minutes. The data is then sent to a monitor for visualization. There are multiple Food and Drug Administration (FDA)- approved devices for continuous glucose monitoring. The FDA considers a device to be accurate if 99% of blood glucose measurements are within 20% of lab results and if 95% of blood glucose measurements are within 15% of lab results.[2]
The accuracy and precision of CGM devices is improving with several products gaining FDA approval. CGM data has been deemed accurate for self-use to adjusted insulin dosage, detection of hypoglycemia and determining the clinical response to therapy. However, events of low glucose readings and false alarms have been reported.[3]
An analysis conducted of the reports to the FDA Manufacturer and User Facility Device Experience (MAUDE) database since 2015 revealed over 25,000 complaints of CGM device inaccuracy.[4] Although CGM devices are researched extensively, there are no studies confirming that the measurements amongst the right arm and left arm are the same.
Intermittent fasting is an eating pattern in which individuals alternate between a period (~16 or more hours) of eliminated or restricted food intake, and a period of normal food intake. It has gained popularity in the public due to proposed health benefits including reductions in weight, cholesterol, and blood glucose.[6] There is published evidence that suggests beneficial effects of intermittent fasting on body fat. In an 8-week study, a significant decrease in fat mass was observed in the intermittent fasting group compared to the free-living group (-16.4 vs -2.8%).[8] However, this is the only human study assessing time-restrictive intermittent fasting and its effects on body fat, and there remains a shortage of high-quality evidence. We would like to further expand existing research by assessing the effect of short-term intermittent fasting on body fat.
This study is a controlled, prospective trial that aims to evaluate the difference in glucose readings between the right arm and left arm using continuous glucose monitors. In addition this study aims to evaluate the difference in percent body fat between short-term intermittent fasting and a free-living diet. Subjects will follow their designated diet for 12-14 days. The study will assess any changes in glucose levels, body fat percent, body mass index (BMI), weight, body composition before and after this 12-14 day study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting with Left Arm Exercise | Experimental | Other: Intermittent Fasting, Other: Left Arm ExerciseHealthy volunteers willing to fast for a 16-hour period daily for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily. |
| Intermittent Fasting with Right Arm Exercise | Experimental | Other: Intermittent Fasting, Other: Right Arm ExerciseHealthy volunteers willing to fast for a 16-hour period daily for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily. |
| Free-living Diet with Left Arm Exercise | Experimental | Other: Free-Living Diet, Other: Left Arm ExerciseHealthy volunteers maintaining their current diet for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily. |
| Free-living Diet with Right Arm Exercise | Experimental | Other: Free-Living Diet, Other: Right Arm ExerciseHealthy volunteers maintaining their current diet for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 18-65 years of age
- Willing to wear CGM device for 12-14 days on both arms
- Have active health insurance
- Willing to refrain from any heat therapy for the duration of the study
- Having an interest to comply with the fasting requirements of the study as appropriate
Key exclusion criteria (17 listed)
- Any active dermatologic condition on the upper arms
- Implanted medical devices (i.e. pacemaker)
- Critically ill or dialysis patients
- Planned magnetic resonance imaging screening, computed tomography scan, x-ray imaging or high-frequency electrical heat treatment during study period
- Current systemic infections
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 |
|---|---|---|
| Intermittent FastingParticipants will be instructed to limit their daily food consumption to an 8-hour period in the day of their choosing. For the 16-hour fasting period, subjects are to eliminate caloric intake. | Other | Intermittent Fasting with Left Arm Exercise, Intermittent Fasting with Right Arm Exercise |
| Free-Living DietParticipants will maintain their current daily food consumption with no caloric restriction. Patient must not have participated in a specialized diet or weight loss program within 2 weeks of enrollment. | Other | Free-living Diet with Left Arm Exercise, Free-living Diet with Right Arm Exercise |
| Left Arm ExerciseParticipants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the left arm. In the middle of the study, participants will switch to the right arm to complete their unilateral arm exercises. | Other | Free-living Diet with Left Arm Exercise, Intermittent Fasting with Left Arm Exercise |
| Right Arm ExerciseParticipants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the right arm. In the middle of the study, participants will switch to the left arm to complete their unilateral arm exercises. | Other | Free-living Diet with Right Arm Exercise, Intermittent Fasting with Right Arm Exercise |
Primary outcome
Difference in time-matched glucose levels between the right arm and left arm
Time frame: 12-14 days
Difference in body-fat percentage before and after 12-14 days of designated diet
Time frame: 12-14 days
14 secondary outcomes
Difference in glucose readings between the right arm and left arm before and after 20-minutes of unilateral arm exercise
Time frame: 12-14 days
Difference in glucose readings between the right arm and left arm per designated diet
Time frame: 12-14 days
Change in Body Mass Index before and after 12-14 days of designated diet
Time frame: 12-14 days
Change in Body Fat Analysis before and after 12-14 days of designated diet
Time frame: 12-14 days
Difference in percent of total glucose readings in hypoglycemic range (Interstitial BG <70mg/dL) between the right arm and left arm
Time frame: 12-14 days
Difference in percent of total glucose readings in euglycemic range (Interstitial BG 70mg/dL-180mg/dL) between the right arm and left arm
Time frame: 12-14 days
Difference in percent of total glucose readings in hyperglycemic range (Interstitial BG >180mg/dL) between the right arm and left arm
Time frame: 12-14 days
Difference in percent of total glucose readings in hypoglycemic range (Interstitial BG <70mg/dL) between designated diet groups
Time frame: 12-14 days
Difference in percent of total glucose readings in euglycemic range (Interstitial BG 70mg/dL-180mg/dL) between designated diet groups
Time frame: 12-14 days
Difference in percent of total glucose readings in hyperglycemic range (Interstitial BG >180mg/dL) between designated diet groups
Time frame: 12-14 days
Time in range (Interstitial BG 70mg/dL-180mg/dL) between the right arm and left arm
Time frame: 12-14 days
Time below range (Interstitial BG <70 mg/dL) between the right arm and left arm
Time frame: 12-14 days
Time in range (Interstitial BG 70mg/dL-180mg/dL) between designated diet groups
Time frame: 12-14 days
Time below range (Interstitial BG <70 mg/dL) between designated diet groups
Time frame: 12-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background2. Food and Drug Administration. Self-monitoring blood glucose test systems for over-the-counter use-guidance for industry and food and drug administration staff. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf. Accessed October 10, 2016.
- Background1. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D: The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care 2009;32:1378-1383
- Background: PubMed 26784127Rodbard D. Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities. Diabetes Technol Ther. 2016 Feb;18 Suppl 2(Suppl 2):S3-S13. doi: 10.1089/dia.2015.0417.
- Background: PubMed 28540756Shapiro AR. Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe? J Diabetes Sci Technol. 2017 Jul;11(4):833-838. doi: 10.1177/1932296816688303. Epub 2017 Mar 1.
- Background: PubMed 17413096Stote KS, Baer DJ, Spears K, Paul DR, Harris GK, Rumpler WV, Strycula P, Najjar SS, Ferrucci L, Ingram DK, Longo DL, Mattson MP. A controlled trial of reduced meal frequency without caloric restriction in healthy, normal-weight, middle-aged adults. Am J Clin Nutr. 2007 Apr;85(4):981-8. doi: 10.1093/ajcn/85.4.981.
- Background: PubMed 27737674Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.
- Derived from this study: PubMed 33955249Kawakatsu S, Liu X, Tran B, Tran BP, Manzanero L, Shih E, Shek A, Lim JJ. Differences in Glucose Readings Between Right Arm and Left Arm Using a Continuous Glucose Monitor. J Diabetes Sci Technol. 2022 Sep;16(5):1183-1189. doi: 10.1177/19322968211008838. Epub 2021 May 6.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting, Free-Living Diet and Left Arm Exercise in people with Diabetes, run by University of the Pacific 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Essie Liu, PharmD (707-423-3277, xliu2@pacific.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in time-matched glucose levels between the right arm and left arm (time frame: 12-14 days). 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?
On the ClinicalTrials.gov record for NCT04102657, which also lists 7 linked publications.
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 25 Sep 2019.