Use of CGM in Kidney Transplant Recipients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Transplant; Complications, Diabetes Mellitus, Type 2, Insulin Dependent Diabetes

Intervention / Treatment
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* Device: Dexcom G6
* Device: Dexcom G6 blinded sensor


Participation Criteria
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Eligibility Criteria
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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 Illiterate Prisoners 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We propose a single-center, prospective, randomized study comprising 2 study arms. They will be randomized in a stratified fashion. Stratification will be according to whether or not they are on prednisone and their estimated glomerular filtration rate. This is to ensure that both arms are populated by equal numbers of patients with prednisone and with worse renal function
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous glucose monitoring (CGM)<br>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. | Device: Dexcom G6<br>* access to continuous glucose monitoring in the Dexcom G6 arm 24/7<br>|
| Placebo Comparator: Self monitoring of blood glucose (fingersticks)<br>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. | Device: Dexcom G6 blinded sensor<br>* retrospective access to continuous glucose profile after 10 days of wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range (70-180 mg/dl) | 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. | 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic variability | assessed by the Coefficient of Variation (Glucose standard deviation divided by mean glucose). % CV is a standardized measure that assesses the magnitude of glucose variability | 70 days | 
| CGM satisfaction questionnaire (10 questions) | score on CGM questionnaire (1 = lowest and 5 = highest) | up to 70 days | 
| Adherence to Diabetic Diet | Use of ASA24 online 24 hr dietary recall at 3 times throughout the study | up to 70 days | 
| Incidence of all-cause emergency room utilization and rehospitalizations | during the study period (70 days) | 70 days | 
| Incidence of post-transplant infections during study period | during the study period (70 days) | 70 days |