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

NCT05741489 | Completed Results FDA Device

• 1 other identifier: STUDY00004617
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

End Stage Kidney Disease

Keywords

Burnt-out diabetes; Dialysis; End stage renal disease; Kidney failure

Outcome Measures

Primary Outcomes (12)

• Percent of Time in Range (TIR) Between 70-180 mg/dL

  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.

  Up to 10 days

• Percent of Time Above Range (Blood Glucose >180 mg/dL)

  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.

  Up to 10 days

• Percent of Time Above Range (Blood Glucose >250 mg/dL)

  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.

  Up to 10 days

• Duration of Hyperglycemia (Blood Glucose >180 mg/dL)

  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.

  Up to 10 days

• Duration of Hyperglycemia (Blood Glucose >250 mg/dL)

  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.

  Up to 10 days

• Number of Participants With Hyperglycemic Episodes With Blood Glucose >250 mg/dL

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

  Up to Day 10

• Percent of Time Below Range (Blood Glucose <70 mg/dL)

  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.

  Up to 10 days

• Percent of Time Below Range (Blood Glucose <54 mg/dL)

  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.

  Up to 10 days

• 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.

  Up to Day 10

• Number of Participants With Hypoglycemic Episodes

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

  Up to Day 10

• 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.

  Up to Day 10

• Number of Participants With Nocturnal Hypoglycemic Episodes

  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).

  Up to Day 10

Secondary Outcomes (2)

• Mean Daily Blood Glucose Concentration

  Up to Day 10

• Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE)

  Up to 10 Days

Study Arms (2)

ESKD with Burnt-out Diabetes

EXPERIMENTAL

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

Device: Continuous glucose monitoring (CGM)

ESKD without Diabetes

EXPERIMENTAL

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

Device: Continuous glucose monitoring (CGM)

Interventions

Continuous glucose monitoring (CGM) DEVICE

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.

Also known as: Dexcom G6 CGM

ESKD with Burnt-out Diabetes; ESKD without Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead

Study Sites (4)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory Dialysis at Northside

Atlanta, Georgia, 30318, United States

Location

Emory Dialysis at Greenbriar

Atlanta, Georgia, 30331, United States

Location

Emory Dialysis at Candler

Decatur, Georgia, 30034, United States

Location

Related Publications (1)

• Kaminski CY, Galindo RJ, Navarrete JE, Zabala Z, Moazzami B, Gerges A, McCoy RG, Fayfman M, Vellanki P, Idrees T, Peng L, Umpierrez GE. Assessment of Glycemic Control by Continuous Glucose Monitoring, Hemoglobin A1c, Fructosamine, and Glycated Albumin in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes. Diabetes Care. 2024 Feb 1;47(2):267-271. doi: 10.2337/dc23-1276.

  PMID: 38085705 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Dr. Guillermo E. Umpierrez
• Organization: Emory University

geumpie@emory.edu

(404) 778-1663

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 23, 2023
• Study Start: August 10, 2022
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)