Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-02 @ 5:23 PM
Study NCT ID:
NCT04102657
Status:
UNKNOWN
Last Update Posted:
2019-09-25
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Glucose Differences Between Left Arm and Right Arm Using a Continuous Glucose Monitor
Sponsor:
University of the Pacific
Organization:
Study Overview
Official Title:
Blood Glucose Differences Between Left Arm and Right Arm Using a Continuous Glucose
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: