Skip to main content
Clinical Trials/NCT04783441
NCT04783441
Recruiting
Not Applicable

Continuous Glucose Monitoring (CGM) to Improve Glycemic Control in Kidney Transplant Recipients

University of California, Davis1 site in 1 country80 target enrollmentJune 29, 2021

Overview

Phase
Not Applicable
Intervention
Dexcom G6
Conditions
Kidney Transplant; Complications
Sponsor
University of California, Davis
Enrollment
80
Locations
1
Primary Endpoint
Time in Range (70-180 mg/dl)
Status
Recruiting
Last Updated
3 months ago

Overview

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 mg/dL) 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 (i.e., 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 (BG\>180). 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 mg/dL) 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 24/7 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.

Registry
clinicaltrials.gov
Start Date
June 29, 2021
End Date
December 31, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18 or above
  • Received a kidney transplant within the past year with functioning kidney (eGFR \> 30 mL/min
  • Person with Type 2 Diabetes and on insulin
  • Access to home wi-fi connection

Exclusion Criteria

  • Person with Type 1 Diabetes
  • Patients taking hydroxyurea
  • Patient unable to wear the Dexcom G6 device at all times for any reason
  • Must be able to test blood glucose with meter 4x a day when on blinded CGM.
  • Presence of clinically significant visual or cognitive impairment
  • Women who are pregnant, who plan to become pregnant during the course of the study, or who are breastfeeding
  • Presence of clinically unstable cardiovascular disease
  • Active malignancy treatment

Arms & Interventions

Continuous glucose monitoring (CGM)

Those in the intervention arm will wear a continuous glucose monitoring device. They only need to perform blood glucose fingersticks if the CGM transmission is lost for a prolonged period of time or in cases of hypo- or hyperglycemia when symptoms don't align with blood glucose readings.

Intervention: Dexcom G6

Self monitoring of blood glucose (fingersticks)

The control arm will remain on standard-of-care SMBG while the intervention arm will use their CGM. The control arm utilizing SMBG will be required to have at minimum 4 glucose checks per day.

Intervention: Dexcom G6 blinded sensor

Outcomes

Primary Outcomes

Time in Range (70-180 mg/dl)

Time Frame: 70 days

1\) Time in Range: Number of minutes per day or percentage of time that glucose levels are in low (BG\<70), target (BG 70-180), high (BG \>180) or very high (BG\>250) ranges.

Secondary Outcomes

  • Incidence of post-transplant infections during study period(70 days)
  • CGM satisfaction questionnaire (10 questions)(up to 70 days)
  • Adherence to Diabetic Diet(up to 70 days)
  • Glycemic variability(70 days)
  • Incidence of all-cause emergency room utilization and rehospitalizations(70 days)

Study Sites (1)

Loading locations...

Similar Trials