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

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05741489

Collaborator

(none)

Enrollment

Locations

Arms

8.7

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Kidney Disease	Device: Continuous glucose monitoring (CGM)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 10, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESKD with Burnt-out Diabetes Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days.	Device: Continuous glucose monitoring (CGM) 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. Other Names: Dexcom G6 CGM
Experimental: ESKD without Diabetes Non-diabetic participants with ESKD wearing a CGM for 10 days.	Device: Continuous glucose monitoring (CGM) 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. Other Names: Dexcom G6 CGM

Arm

Intervention/Treatment

Experimental: ESKD with Burnt-out Diabetes

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

Device: Continuous glucose monitoring (CGM)

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.

Other Names:

Dexcom G6 CGM

Experimental: ESKD without Diabetes

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

Device: Continuous glucose monitoring (CGM)

Other Names:

Dexcom G6 CGM

Outcome Measures

Primary Outcome Measures

Hypoglycemia Event Rate [Up to Day 10]
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 [Up to Day 10]
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 [Up to Day 10]
Glycemic control is assessed as mean daily glucose concentration, measured by Dexcom G6 CGM.
Hemoglobin A1C (HbA1C) [Up to Day 10]
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 [Up to Day 10]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
2	Emory Dialysis at Northside	Atlanta	Georgia	United States	30318
3	Emory Dialysis at Greenbriar	Atlanta	Georgia	United States	30331
4	Emory Dialysis at Candler	Decatur	Georgia	United States	30034