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Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)

Primary Purpose

End-Stage Renal Disease, Type 2 Diabetes

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)

POC BG

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring ESRD, Continuous Glucose Monitoring, Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adult subjects with type 2 diabetes
receiving hemodialysis (for at least 90 days)
treated with insulin therapy [basal insulin alone (glargine U100, glargine U300, determir, degludec, NPH)], or in combination with bolus insulin (at least one or more injections of aspart, lispro, glulisine, regular insulin) or in combination with incretin therapy (DPPIV or GLP1)
willingness to wear the CGM
currently performing self-monitored blood glucose (at least 2 times daily).

Exclusion Criteria:

use of sulfonylureas or thiazolidinediones alone or in combination with insulin
use of personal/real-time CGM 3 months prior to study entry (blinded CGM is allowed)
prior use of insulin pumps or hybrid close loop systems (for at least the prior 28 days)
current or anticipated use of stress steroids doses (prednisone ≤5mg or its equivalent is allowed)
subjects who are sensitive or allergic to adhesive
extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual or hearing impairment, active alcohol or drug abuse, mental illness) or pose excessive risk to study staff handling venous blood samples
situations that will limit the subject's ability to comply with the protocol (per investigator discretion)
active malignancy
unable to give informed consent
at least 10% of time spent in clinical relevant hypoglycemia (<54 mg/dl) during blinded CGM period
significant hypoglycemia (< 40 mg/dL)
severe hyperglycemia (BG> 400 mg/dL)
extensive skin abnormalities at insertion sites
pregnancy or breastfeeding
severe anemia (Hemoglobin < 5 mg/dl)
polycythemia (Hemoglobin >17 mg/dl)
subjects taking acetaminophen (more than 1 gr every six hours)
hydroxyurea (may cause interference with the sensor membrane).

Sites / Locations

Emory Clinic
Grady Health System (non-CRN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)

Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)

Arm Description

Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks.

Patients with type 2 DM treated with insulin and receiving hemodialysis will use POC BG for 4 weeks, then 2 weeks of wash-out period, and cross over to use a real-time/personal CGM for 4 weeks (Control-Intervention Group).

Outcomes

Primary Outcome Measures

Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).

Secondary Outcome Measures

% time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)

Mean % time in hypoglycemia (< 54 mg/dL)

% time in hypoglycemia (<54 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).

% time in hyperglycemia (>180 mg/dL)

% time in hyperglycemia (>180 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).

% time in hyperglycemia (>250 mg/dl)

% time in hyperglycemia (>250 mg/dL) during the intervention phase, compared to control in both groups

Glycemic variability [% coefficient of variation (%CV)

% coefficient of variation will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. contro-intervention).

Mean amplitude of glucose excursions (MAGE)

Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention).

Change in HbA1C at 3 months follow up

Change in HbA1C at 3 months follow up from baseline

Number of hospitalization or emergency room visits for hypoglycemia

Rate of hospitalization or emergency room visits for hypoglycemia will be recorded

Number of hospitalization or emergency room visits for diabetes ketoacidosis

Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded

Full Information

NCT ID

NCT04473430

First Posted

July 13, 2020

Last Updated

May 10, 2023

Sponsor

Emory University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT04473430

Brief Title

Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)

Official Title

Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 5, 2020 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated with insulin therapy and receiving hemodialysis.

Detailed Description

The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis. The study will provide novel insights into the glycemic exposure patterns among dialysis patients and will provide preliminary data for future outcomes-based studies determining the best glycemic targets for this group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-Stage Renal Disease, Type 2 Diabetes

Keywords

ESRD, Continuous Glucose Monitoring, Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)

Arm Type

Experimental

Arm Description

Arm Title

Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)

Intervention Description

Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective "urgent low soon" alarm, with proven prediction of hypoglycemia within 20 minutes in advance. The sensor uses a novel semi-permeable membrane that blocks interference with most clinically relevant substances, including high levels of urea and creatinine, and commonly used medications. Dexcom G6 CGM is a commercially-available, minimally invasive sensor, with a flexible and thin wire that is inserted into the abdominal subcutaneous tissue. Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the "urgent low soon" alarm (predictive of hypoglycemia < 55 mg/dL within the preceding 20 minutes).

Intervention Type

Diagnostic Test

Intervention Name(s)

POC BG

Intervention Description

POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.

Primary Outcome Measure Information:

Title

Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).

Description

Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

% time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)

Description

% time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)

Time Frame

Up to 3 months

Title

Mean % time in hypoglycemia (< 54 mg/dL)

Description

% time in hypoglycemia (<54 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).

Time Frame

Up to 3 months

Title

% time in hyperglycemia (>180 mg/dL)

Description

% time in hyperglycemia (>180 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).

Time Frame

Up to 3 months

Title

% time in hyperglycemia (>250 mg/dl)

Description

% time in hyperglycemia (>250 mg/dL) during the intervention phase, compared to control in both groups

Time Frame

Up to 3 months

Title

Glycemic variability [% coefficient of variation (%CV)

Description

% coefficient of variation will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. contro-intervention).

Time Frame

Up to 3 months

Title

Mean amplitude of glucose excursions (MAGE)

Description

Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention).

Time Frame

Up to 3 months

Title

Change in HbA1C at 3 months follow up

Description

Change in HbA1C at 3 months follow up from baseline

Time Frame

Baseline, Up to 3 months

Title

Number of hospitalization or emergency room visits for hypoglycemia

Description

Rate of hospitalization or emergency room visits for hypoglycemia will be recorded

Time Frame

Up to 3 months

Title

Number of hospitalization or emergency room visits for diabetes ketoacidosis

Description

Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded

Time Frame

Up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adult subjects with type 2 diabetes receiving hemodialysis (for at least 90 days) treated with insulin therapy [basal insulin alone (glargine U100, glargine U300, determir, degludec, NPH)], or in combination with bolus insulin (at least one or more injections of aspart, lispro, glulisine, regular insulin) or in combination with incretin therapy (DPPIV or GLP1) willingness to wear the CGM currently performing self-monitored blood glucose (at least 2 times daily). Exclusion Criteria: use of sulfonylureas or thiazolidinediones alone or in combination with insulin use of personal/real-time CGM 3 months prior to study entry (blinded CGM is allowed) prior use of insulin pumps or hybrid close loop systems (for at least the prior 28 days) current or anticipated use of stress steroids doses (prednisone ≤5mg or its equivalent is allowed) subjects who are sensitive or allergic to adhesive extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual or hearing impairment, active alcohol or drug abuse, mental illness) or pose excessive risk to study staff handling venous blood samples situations that will limit the subject's ability to comply with the protocol (per investigator discretion) active malignancy unable to give informed consent at least 10% of time spent in clinical relevant hypoglycemia (<54 mg/dl) during blinded CGM period significant hypoglycemia (< 40 mg/dL) severe hyperglycemia (BG> 400 mg/dL) extensive skin abnormalities at insertion sites pregnancy or breastfeeding severe anemia (Hemoglobin < 5 mg/dl) polycythemia (Hemoglobin >17 mg/dl) subjects taking acetaminophen (more than 1 gr every six hours) hydroxyurea (may cause interference with the sensor membrane).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillermo Umpierrez, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory Clinic

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Grady Health System (non-CRN)

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared

IPD Sharing Time Frame

Start 6 months after publication End 12 months after publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal will get access. Proposals should be directed to rodolfo.galindo@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)

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