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Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes

Primary Purpose

End Stage Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous glucose monitoring (CGM)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Kidney Disease focused on measuring Burnt-out diabetes, Dialysis, End stage renal disease, Kidney failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Dialysis treatment for more than 3 months HbA1c less than 6.5% at the first clinic visit Willing to wear a CGM for 10 days Exclusion Criteria: Have used insulin or any diabetes treatment during the last 3 months Be pregnant or plan to become pregnant during the study Known allergy to medical-grade adhesives Taking acetaminophen (more than 1 gram every six hours) or hydroxyurea (may interfere with sensor membrane) Current or anticipated use of stress steroid doses (prednisone </= 5 mg or its equivalent is allowed)

Sites / Locations

  • Grady Memorial HospitalRecruiting
  • Emory Dialysis at NorthsideRecruiting
  • Emory Dialysis at GreenbriarRecruiting
  • Emory Dialysis at CandlerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESKD with Burnt-out Diabetes

ESKD without Diabetes

Arm Description

Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days.

Non-diabetic participants with ESKD wearing a CGM for 10 days.

Outcomes

Primary Outcome Measures

Hypoglycemia Event Rate
Hypoglycemia is defined as blood glucose < 70 mg/dL and is assessed by Dexcom G6 CGM. The hypoglycemic event rate is defined as the number of hypoglycemic events per patient per day.
Nocturnal Hypoglycemia Event Rate
Hypoglycemia is defined as blood glucose < 70 mg/dL and is assessed by Dexcom G6 CGM. A nocturnal hypoglycemia episode is defined as an episode occurring during the time interval of 10:00 Post Meridiem (PM) to 6:00 Ante Meridiem (AM). The hypoglycemic event rate is defined as the number of hypoglycemic events per patient per day.

Secondary Outcome Measures

Mean Daily Blood Glucose Concentration
Glycemic control is assessed as mean daily glucose concentration, measured by Dexcom G6 CGM.
Hemoglobin A1C (HbA1C)
The most recent HbA1c value will be compared between study arms. Normal values are less than 5.7%, while values of 6.5% and above indicate diabetes.
Comorbidities
A composite of comorbidities of hypertension, cardiovascular disease, heart failure, peripheral neuropathy, autonomic/GI neuropathy, cerebrovascular disease, peripheral vascular disease, depression, anxiety, and cognitive impairment/dementia will be compared between study arms.

Full Information

First Posted
February 14, 2023
Last Updated
February 14, 2023
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05741489
Brief Title
Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
Official Title
Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Twenty participants with end stage kidney disease (ESKD) and burnt-out diabetes, and 20 non-diabetic participants with ESKD will wear a continuous glucose monitoring (CGM) device for 10 days to see if the use of CGM is a better tool to assess glycemic control than glycosylated hemoglobin (HbA1c) in patients with ESKD on dialysis.
Detailed Description
More than 37 million adults, or 14.7% of all Americans aged 18 and older, are living with diabetes. Controlling hyperglycemia is foundational to diabetes management and is necessary to reduce the risks of chronic diabetes complications and death. Diabetic nephropathy accounts for great morbidity, as diabetes is the number one cause of chronic kidney disease (CKD) and end stage kidney disease (ESKD) in the United States. It is estimated that diabetes affects up to 40% of patients with ESKD. Assessment of glucose control in patients with advanced CKD/ESKD is complex due to changes in glucose homeostasis, potential effects on assays of glycemia, and altered pharmacokinetics of diabetes medications. Glycosylated hemoglobin (HbA1c) has been the gold standard to assess glycemic control in patients with diabetes. HbA1c reflects the average glycemic value over approximately 3 months. Although HbA1c is associated with chronic complications of diabetes in patients with normal kidney function, its predictive value is uncertain in patients with ESKD. Continuous glucose monitoring (CGM) technology in the outpatient setting has transformed glucose monitoring for diabetes self-management, providing more comprehensive glycemic control data than intermittent point-of-care capillary blood glucose monitoring and HbA1c. Once progressed to ESKD, up to one fourth of patients experience resolution of their hyperglycemia, as defined by an HbA1c level of less than 6.5%, and consequently are no longer on antidiabetic agents and insulin. This phenomenon is known as "burnt-out diabetes" which is likely due to various underlying factors, including but not limited to, malnutrition, reduced clearance and degradation of insulin, decreased kidney gluconeogenesis, and accumulation of uremic toxins. These patients are likely at a greater risk of morbidity and mortality and an increased risk of hypoglycemic episodes. There is a need for further research in patients with ESKD to establish what is the most appropriate tool to assess glycemic control in those with 'burnt-out diabetes'. This study will use CGM to measure patients' glucose with real-time levels as opposed to relying on surrogate markers like HbA1c. These results can give insight into the reality of glycemic control in these patients and can impact the best monitoring and treatment for patients with burnt-out diabetes. It is not known if patients with burnt-out diabetes have complete normoglycemia or if they may have episodes of (untreated) hyperglycemia, which may be associated with poor outcomes. The researchers of this study will compare glycemic control by CGM in patients with burnt-out diabetes and non-diabetic patients with ESKD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease
Keywords
Burnt-out diabetes, Dialysis, End stage renal disease, Kidney failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESKD with Burnt-out Diabetes
Arm Type
Experimental
Arm Description
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days.
Arm Title
ESKD without Diabetes
Arm Type
Experimental
Arm Description
Non-diabetic participants with ESKD wearing a CGM for 10 days.
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring (CGM)
Other Intervention Name(s)
Dexcom G6 CGM
Intervention Description
The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants will wear the CGM with the display off for 10 days while continuing their routine dialysis sessions.
Primary Outcome Measure Information:
Title
Hypoglycemia Event Rate
Description
Hypoglycemia is defined as blood glucose < 70 mg/dL and is assessed by Dexcom G6 CGM. The hypoglycemic event rate is defined as the number of hypoglycemic events per patient per day.
Time Frame
Up to Day 10
Title
Nocturnal Hypoglycemia Event Rate
Description
Hypoglycemia is defined as blood glucose < 70 mg/dL and is assessed by Dexcom G6 CGM. A nocturnal hypoglycemia episode is defined as an episode occurring during the time interval of 10:00 Post Meridiem (PM) to 6:00 Ante Meridiem (AM). The hypoglycemic event rate is defined as the number of hypoglycemic events per patient per day.
Time Frame
Up to Day 10
Secondary Outcome Measure Information:
Title
Mean Daily Blood Glucose Concentration
Description
Glycemic control is assessed as mean daily glucose concentration, measured by Dexcom G6 CGM.
Time Frame
Up to Day 10
Title
Hemoglobin A1C (HbA1C)
Description
The most recent HbA1c value will be compared between study arms. Normal values are less than 5.7%, while values of 6.5% and above indicate diabetes.
Time Frame
Up to Day 10
Title
Comorbidities
Description
A composite of comorbidities of hypertension, cardiovascular disease, heart failure, peripheral neuropathy, autonomic/GI neuropathy, cerebrovascular disease, peripheral vascular disease, depression, anxiety, and cognitive impairment/dementia will be compared between study arms.
Time Frame
Up to Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dialysis treatment for more than 3 months HbA1c less than 6.5% at the first clinic visit Willing to wear a CGM for 10 days Exclusion Criteria: Have used insulin or any diabetes treatment during the last 3 months Be pregnant or plan to become pregnant during the study Known allergy to medical-grade adhesives Taking acetaminophen (more than 1 gram every six hours) or hydroxyurea (may interfere with sensor membrane) Current or anticipated use of stress steroid doses (prednisone </= 5 mg or its equivalent is allowed)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Umpierrez, MD
Phone
404-778-1665
Email
geumpie@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Umpierrez, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Dialysis at Northside
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Dialysis at Greenbriar
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Dialysis at Candler
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes

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