Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03207893
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2016-10-28
Brief Title:
Benefits of Continuous Glucose Monitoring With GEM Lifestyle Modification for Adults With Type 2 Diabetes
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Benefits of Adding Continuous Glucose Monitoring to Glycemic Load Exercise and Monitoring of Blood Glucose GEM for Adults With Type 2 Diabetes - Phase 2
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
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:
The purpose of this study is to determine if the use of continuous glucose monitoring with the GEM lifestyle modification program Glycemic load Exercise and Monitoring glucose will result in better diabetes control than routine care
Detailed Description:
Type 2 diabetes t2d is a major epidemic of the developing world which has huge fiscal consequences and many physical complications It is thought to be brought on in part by contemporary easy access to high energy foods and reduced physical activity resulting in increased belly fat that culminates in growing insulin resistance and subsequent hyperglycemia Because of ease and efficacy of medication management t2d is primarily managed with ever-escalating medication use which significantly contributes to medical cost and possibly the progression of the disease itself
An effective supplement or alternative to medication management is lifestyle modification Conventional lifestyle modification focuses on reducing body fat and insulin resistance through weight reduction from caloric restriction and aerobic exercise Sustained routine application of this approach is limited because some individuals do not need to lose weight some do not want to lose weight others cannot lose weight and when successful lifelong weight reduction is difficult to sustain A useful paradigm shift in lifestyle treatment of t2d might be to go from reducing calories to reducing postprandial glucose PPG the primary contributor to glycosylated hemoglobin HbA1c
PPG spikes can be prevented by replacing high with low glycemic load foods and dampened by engaging in postprandial physical activity This is exemplified by the integrated Glycemic load Exercise and Monitoring glucose GEM program It promotes choices of low glycemic load foods and increased physical activity directed by glucose monitoring feedback Glucose feedback can 1 educate people as to what food choices minimize PPG and what physical activity choices directly lower PPG 2 activate individuals when glucose is out of their desired range by alerting them to make choices to lower high glucose or raise low glucose and 3 motivate individuals to repeat those choices that resulted in desirable glucose consequences The educating activating and motivating benefits of glucose feedback are thought to be qualitatively and quantitatively enhanced through continuous glucose monitoring CGM
It is hypothesized that compared to Routine Care RC GEM with CGM GEMCGM administered to adults with t2d who are failing with oral medication management will result in better diabetes control lower HbA1c reduced medication management less medication and better psychological functioning eg greater sense of empowerment in the short term 3 month follow-up Further it is hypothesized that their reduction in HbA1c will be driven by a reduction in PPG
An effective supplement or alternative to medication management is lifestyle modification Conventional lifestyle modification focuses on reducing body fat and insulin resistance through weight reduction from caloric restriction and aerobic exercise Sustained routine application of this approach is limited because some individuals do not need to lose weight some do not want to lose weight others cannot lose weight and when successful lifelong weight reduction is difficult to sustain A useful paradigm shift in lifestyle treatment of t2d might be to go from reducing calories to reducing postprandial glucose PPG the primary contributor to glycosylated hemoglobin HbA1c
PPG spikes can be prevented by replacing high with low glycemic load foods and dampened by engaging in postprandial physical activity This is exemplified by the integrated Glycemic load Exercise and Monitoring glucose GEM program It promotes choices of low glycemic load foods and increased physical activity directed by glucose monitoring feedback Glucose feedback can 1 educate people as to what food choices minimize PPG and what physical activity choices directly lower PPG 2 activate individuals when glucose is out of their desired range by alerting them to make choices to lower high glucose or raise low glucose and 3 motivate individuals to repeat those choices that resulted in desirable glucose consequences The educating activating and motivating benefits of glucose feedback are thought to be qualitatively and quantitatively enhanced through continuous glucose monitoring CGM
It is hypothesized that compared to Routine Care RC GEM with CGM GEMCGM administered to adults with t2d who are failing with oral medication management will result in better diabetes control lower HbA1c reduced medication management less medication and better psychological functioning eg greater sense of empowerment in the short term 3 month follow-up Further it is hypothesized that their reduction in HbA1c will be driven by a reduction in PPG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None