Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783441
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2021-03-01
Brief Title:
Use of CGM in Kidney Transplant Recipients
Sponsor:
Dahlia M Zuidema
Organization:
University of California Davis
Study Overview
Official Title:
Continuous Glucose Monitoring CGM to Improve Glycemic Control in Kidney Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2023-10
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 investigators want to study the impact CGM continuous glucose monitoring has on patients glycemic control as determined by time in range TIR 70-180 mgdL in the Diabetic Kidney Transplant population
Detailed Description:
Diabetes is one of the leading causes of End Stage Renal Disease ESRD Kidney transplantation is the best form of renal replacement therapy to date but requires that recipients of transplant organs maintain a complicated medication regimen in order to prevent graft loss Their medications include lifelong immunosuppression anti-microbials and other maintenance medications ie anti-hypertensives heart-protective regimens bowel care vitamins and pain medications
For many transplant patients glycemic control in the immediate post-operative period can be an additional challenge Glycemic control may be hindered by recent surgery corticosteroids immunosuppressants altered nutritional intake and reduced mobility
Diabetes professional organizations such as the American Diabetes Association ADA and the American Association of Clinical Endocrinologists AACE recommend continuous glucose monitoring CGM for anyone on intensive insulin therapy The biggest benefit of CGM is not just the actual glucose value but also its direction and rate of change CGM data can also be downloaded and reflect patterns of glycemic control throughout the day and night including not only the average blood glucose but also time-in-range TIR and degrees of glycemic variability This can help identify unnotified nightly hypoglycemia or hyperglycemia and help titrate medications to achieve better glycemic control Self-Management of blood glucose SMBG is a key component in effective glycemic management but it places a large burden on the patient Prior to CGM SMBG was the only option to measure daily blood glucose fluctuations but it is an imperfect tool For patients on insulin a blood glucose is checked at minimum 4 times per day prior to meals and at bedtime Additionally the utility of SMBG can be endangered by patient decision making the ability to check blood glucose adherence to testing regimen error due to poor testing technique inadequate blood supply contamination on fingers or inaccuracy of some systems
Numerous studies have shown the clinical benefit of CGM in the type-1 diabetes T1D and type-2 diabetes T2D populations ref Beck Olafsdottir The DIAMOND group Beck showed that CGM improved HBA1C and reduced hyperglycemia BG180 Patients wearing the CGM had high satisfaction scores and low perceived burden CGM is still a new tool outside of the Type 1 Diabetes population but may have significant benefits for any patient on insulin In Feb 2019 an international guideline on TIR defined as blood glucose of 70-180 mgdL was published and TIR may become a new standard for assessing glycemic control
The investigators research focuses on TIR and the benefits of CGM in the kidney transplant population This can be essential for timely adjustments of insulin dosages when dealing with glycemic derangements and steroid induced hyperglycemia CGM can provide an immense opportunity for a continuous 247 view of glucose values glycemic variability direction of change and unrecognized blood glucose levels during nighttime and influence of food and activity on blood glucose values In addition to the metrics described the glucose management indicator GMI or also named estimated A1C eA1C is a measure converting the mean glucose from CGM using a formula derived from glucose readings from a population of individuals into an estimate of a simultaneously measured laboratory A1C this value may serve as an additional tool in assessing glycemic control In conclusion the use of a CGM can aid the provider and care team in better titration of insulin and medication regimen adjustment This research hopes to give insight in a very complex population that has not had access to CGM before
For many transplant patients glycemic control in the immediate post-operative period can be an additional challenge Glycemic control may be hindered by recent surgery corticosteroids immunosuppressants altered nutritional intake and reduced mobility
Diabetes professional organizations such as the American Diabetes Association ADA and the American Association of Clinical Endocrinologists AACE recommend continuous glucose monitoring CGM for anyone on intensive insulin therapy The biggest benefit of CGM is not just the actual glucose value but also its direction and rate of change CGM data can also be downloaded and reflect patterns of glycemic control throughout the day and night including not only the average blood glucose but also time-in-range TIR and degrees of glycemic variability This can help identify unnotified nightly hypoglycemia or hyperglycemia and help titrate medications to achieve better glycemic control Self-Management of blood glucose SMBG is a key component in effective glycemic management but it places a large burden on the patient Prior to CGM SMBG was the only option to measure daily blood glucose fluctuations but it is an imperfect tool For patients on insulin a blood glucose is checked at minimum 4 times per day prior to meals and at bedtime Additionally the utility of SMBG can be endangered by patient decision making the ability to check blood glucose adherence to testing regimen error due to poor testing technique inadequate blood supply contamination on fingers or inaccuracy of some systems
Numerous studies have shown the clinical benefit of CGM in the type-1 diabetes T1D and type-2 diabetes T2D populations ref Beck Olafsdottir The DIAMOND group Beck showed that CGM improved HBA1C and reduced hyperglycemia BG180 Patients wearing the CGM had high satisfaction scores and low perceived burden CGM is still a new tool outside of the Type 1 Diabetes population but may have significant benefits for any patient on insulin In Feb 2019 an international guideline on TIR defined as blood glucose of 70-180 mgdL was published and TIR may become a new standard for assessing glycemic control
The investigators research focuses on TIR and the benefits of CGM in the kidney transplant population This can be essential for timely adjustments of insulin dosages when dealing with glycemic derangements and steroid induced hyperglycemia CGM can provide an immense opportunity for a continuous 247 view of glucose values glycemic variability direction of change and unrecognized blood glucose levels during nighttime and influence of food and activity on blood glucose values In addition to the metrics described the glucose management indicator GMI or also named estimated A1C eA1C is a measure converting the mean glucose from CGM using a formula derived from glucose readings from a population of individuals into an estimate of a simultaneously measured laboratory A1C this value may serve as an additional tool in assessing glycemic control In conclusion the use of a CGM can aid the provider and care team in better titration of insulin and medication regimen adjustment This research hopes to give insight in a very complex population that has not had access to CGM before
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None