NCT05741489

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

Completed NA Results posted Last updated 5 April 2024

What this trial tests

NA trial testing Continuous glucose monitoring (CGM) in End Stage Kidney Disease in 40 participants. Completed in 9 March 2023.

Timeline

10 August 2022

Primary endpoint
9 March 2023

9 March 2023

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	40
Start date	10 August 2022
Primary completion	9 March 2023
Estimated completion	9 March 2023
Sites	4 locations across United States

Drugs / interventions tested

• Continuous glucose monitoring (CGM)

Conditions studied

• End Stage Kidney Disease — all drugs for End Stage Kidney Disease →

Sponsor

Emory University

Who can join

18 and older, any sex, with End Stage Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Time in Range (TIR) Between 70-180 mg/dL Primary · Up to 10 days

Glycemic control is measured as the percentage of time that blood glucose levels are in the range of 70 and 180 mg/dL, as measured by CGM.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	80.4	± 14.0
ESKD Without Diabetes	94.0	± 6.4

Percent of Time Above Range (Blood Glucose >180 mg/dL) Primary · Up to 10 days

Glycemic control is assessed a the percentage of time in hyperglycemia, defined as the time above range (TAR) with blood glucose measurements \>180 mg/dL, as measured by CGM.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	17.2	± 14.1
ESKD Without Diabetes	4.6	± 5.3

Percent of Time Above Range (Blood Glucose >250 mg/dL) Primary · Up to 10 days

Glycemic control is assessed a the percentage of time in hyperglycemia, defined as the time above range (TAR) with blood glucose measurements \>250 mg/dL, as measured by CGM.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	2.0	± 3.0
ESKD Without Diabetes	0.1	± 0.4

Duration of Hyperglycemia (Blood Glucose >180 mg/dL) Primary · Up to 10 days

Glycemic control is assessed as the duration of hyperglycemia with blood glucose measurements \>180 mg/dL, as measured by CGM for hyperglycemia time periods of greater than 15 minutes.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	4.1	± 3.4
ESKD Without Diabetes	1.1	± 1.3

Duration of Hyperglycemia (Blood Glucose >250 mg/dL) Primary · Up to 10 days

Glycemic control is assessed as the duration of hyperglycemia with blood glucose measurements \>250 mg/dL, as measured by CGM for hyperglycemia time periods of greater than 15 minutes.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	0.5	± 0.7
ESKD Without Diabetes	0.1	± 0.1

Number of Participants With Hyperglycemic Episodes With Blood Glucose >250 mg/dL Primary · Up to Day 10

The number of participants experiencing hyperglycemia with blood glucose levels \> 250 mg/dL as measured by CGM.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	11
ESKD Without Diabetes	3

Percent of Time Below Range (Blood Glucose <70 mg/dL) Primary · Up to 10 days

Glycemic control is assessed a the percentage of time in hypoglycemia, defined as the time below range (TBR) with blood glucose measurements \< 70 mg/dL, as measured by CGM.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	2.5	± 5.8
ESKD Without Diabetes	1.5	± 5.0

Percent of Time Below Range (Blood Glucose <54 mg/dL) Primary · Up to 10 days

Glycemic control is assessed a the percentage of time in severe hypoglycemia, defined as the time below range (TBR) with blood glucose measurements \< 54 mg/dL, as measured by CGM.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	1.3	± 3.5
ESKD Without Diabetes	0.4	± 1.7

Hypoglycemia Event Rate Primary · 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.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	3.60	± 7.37
ESKD Without Diabetes	3.44	± 10.43

Number of Participants With Hypoglycemic Episodes Primary · Up to Day 10

The number of participants experiencing hypoglycemia with blood glucose levels \< 70 mg/dL as measured by CGM.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	10
ESKD Without Diabetes	11

Nocturnal Hypoglycemia Event Rate Primary · 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.

Group	Value	95% CI
ESKD With Burnt-out Diabetes	1.30	± 3.05
ESKD Without Diabetes	0.94	± 2.86

Number of Participants With Nocturnal Hypoglycemic Episodes Primary · Up to Day 10

The number of participants experiencing nocturnal hypoglycemia with blood glucose levels \< 70 mg/dL as measured by 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).

Group	Value	95% CI
ESKD With Burnt-out Diabetes	7
ESKD Without Diabetes	4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.