Trial Outcomes & Findings for Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes (NCT NCT05741489)
NCT ID: NCT05741489
Last Updated: 2024-04-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Up to 10 days
Results posted on
2024-04-05
Participant Flow
Participants were recruited from Emory Dialysis centers in Atlanta, Georgia, USA. Participant enrollment began August 10, 2022 and all follow-up assessments were completed by March 9, 2023.
Participant milestones
| Measure |
End-Stage Kidney Disease (ESKD) With Burnt-out Diabetes
Participants with end stage kidney disease (ESKD) and burnt-out diabetes wearing a continuous glucose monitoring (CGM) for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
Baseline characteristics by cohort
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=20 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Coronary artery disease
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Heart failure
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Hypertension
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
< 5.7%
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
5.7 to < 6.5%
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Glycated albumin level
less than 13.6%
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Glycated albumin level
13.6% to < 16%
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Glycated albumin level
greater than or equal to 16%
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Glycated albumin level
not assessed
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Fructosamine level (mmol/L)
less than 285
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Fructosamine level (mmol/L)
greater than or equal to 285
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Fructosamine level (mmol/L)
not assessed
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 10 daysGlycemic 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Percent of Time in Range (TIR) Between 70-180 mg/dL
|
80.4 percentage of time
Standard Deviation 14.0
|
94.0 percentage of time
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: Up to 10 daysGlycemic 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Percent of Time Above Range (Blood Glucose >180 mg/dL)
|
17.2 percentage of time
Standard Deviation 14.1
|
4.6 percentage of time
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Up to 10 daysGlycemic 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Percent of Time Above Range (Blood Glucose >250 mg/dL)
|
2.0 percentage of time
Standard Deviation 3.0
|
0.1 percentage of time
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Up to 10 daysGlycemic 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Duration of Hyperglycemia (Blood Glucose >180 mg/dL)
|
4.1 hours per day
Standard Deviation 3.4
|
1.1 hours per day
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Up to 10 daysGlycemic 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Duration of Hyperglycemia (Blood Glucose >250 mg/dL)
|
0.5 hours per day
Standard Deviation 0.7
|
0.1 hours per day
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: Up to Day 10The number of participants experiencing hyperglycemia with blood glucose levels \> 250 mg/dL as measured by CGM.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Number of Participants With Hyperglycemic Episodes With Blood Glucose >250 mg/dL
|
11 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 10 daysGlycemic 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Percent of Time Below Range (Blood Glucose <70 mg/dL)
|
2.5 percentage of time
Standard Deviation 5.8
|
1.5 percentage of time
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: Up to 10 daysGlycemic 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Percent of Time Below Range (Blood Glucose <54 mg/dL)
|
1.3 percentage of time
Standard Deviation 3.5
|
0.4 percentage of time
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Up to Day 10Hypoglycemia 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Hypoglycemia Event Rate
|
3.60 events per patient per day
Standard Deviation 7.37
|
3.44 events per patient per day
Standard Deviation 10.43
|
PRIMARY outcome
Timeframe: Up to Day 10The number of participants experiencing hypoglycemia with blood glucose levels \< 70 mg/dL as measured by CGM.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Number of Participants With Hypoglycemic Episodes
|
10 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Up to Day 10Hypoglycemia 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.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Nocturnal Hypoglycemia Event Rate
|
1.30 events per patient per day
Standard Deviation 3.05
|
0.94 events per patient per day
Standard Deviation 2.86
|
PRIMARY outcome
Timeframe: Up to Day 10The 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).
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Number of Participants With Nocturnal Hypoglycemic Episodes
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Day 10Glycemic control is assessed as mean daily glucose concentration, measured by Dexcom G6 CGM.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Mean Daily Blood Glucose Concentration
|
141.7 mg/dL
Standard Deviation 22.2
|
125.7 mg/dL
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Up to 10 DaysMean amplitude of glycemic excursions (MAGE) is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard deviation (SD) of mean glucose values. It is designated to assess major glucose swings and exclude minor ones.
Outcome measures
| Measure |
ESKD With Burnt-out Diabetes
n=20 Participants
Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
ESKD Without Diabetes
n=18 Participants
Non-diabetic participants with ESKD wearing a CGM for 10 days. The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants wore the CGM with the display off for 10 days while continuing their routine dialysis sessions.
|
|---|---|---|
|
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE)
|
54.9 mg/dL
Standard Deviation 18.2
|
42.4 mg/dL
Standard Deviation 9.4
|
Adverse Events
ESKD With Burnt-out Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ESKD Without Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place