N/A
N=40
Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
End Stage Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT05741489 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Percent of Time in Range (TIR) Between 70-180 mg/dL — 80.4; 94.0 percentage of time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous glucose monitoring (CGM) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Time in Range (TIR) Between 70-180 mg/dL |
80.4; 94.0 | — |
| PRIMARY Percent of Time Above Range (Blood Glucose >180 mg/dL) |
17.2; 4.6 | — |
| PRIMARY Percent of Time Above Range (Blood Glucose >250 mg/dL) |
2.0; 0.1 | — |
| PRIMARY Duration of Hyperglycemia (Blood Glucose >180 mg/dL) |
4.1; 1.1 | — |
| PRIMARY Duration of Hyperglycemia (Blood Glucose >250 mg/dL) |
0.5; 0.1 | — |
| PRIMARY Number of Participants With Hyperglycemic Episodes With Blood Glucose >250 mg/dL |
11; 3 | — |
| PRIMARY Percent of Time Below Range (Blood Glucose <70 mg/dL) |
2.5; 1.5 | — |
| PRIMARY Percent of Time Below Range (Blood Glucose <54 mg/dL) |
1.3; 0.4 | — |
| PRIMARY Hypoglycemia Event Rate |
3.60; 3.44 | — |
| PRIMARY Number of Participants With Hypoglycemic Episodes |
10; 11 | — |
| PRIMARY Nocturnal Hypoglycemia Event Rate |
1.30; 0.94 | — |
| PRIMARY Number of Participants With Nocturnal Hypoglycemic Episodes |
7; 4 | — |
| SECONDARY Mean Daily Blood Glucose Concentration |
141.7; 125.7 | — |
| SECONDARY Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) |
54.9; 42.4 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT05741489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.