End-Stage Renal DiseaseNCT04473430
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)
A study testing Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM) and POC Glucose Testing in people with End-Stage Renal Disease and Type 2 Diabetes, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-Stage Renal Disease, Type 2 Diabetes
- What is being tested?
- Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM) and POC Glucose Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Nov 2020to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult subjects with type 2 diabetes
- receiving hemodialysis (for at least 90 days)
- treated with insulin therapy [basal insulin alone (glargine U100, glargine U300, detemir, 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).
Who cannot join
- 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
Show all 19Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Clinic
Atlanta, Georgia, 30322
Grady Health System (non-CRN)
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Conditions
- End-Stage Renal Disease, Type 2 Diabetes
- Being tested
- Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM), POC Glucose Testing
- Keywords
- ESRD, Continuous Glucose Monitoring, Diabetes
- Medical subject headings
- Kidney Failure, Chronic, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM)Device
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.
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).
Diagnostic Test: Real-time CGM will be used to collect outcomes variables
POC Glucose TestingDevice
POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.
Diagnostic Test: Professional CGM will be used to collect outcomes variables (including during the POC BG testing).
| Study group | Role | What they receive |
|---|---|---|
| Real-time Dexcom CGM during CGM Intervention | Experimental | 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, for insulin adjustments. Receives: Device: Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM) |
| Professional Dexcom CGM During Point-Of-Care Blood Glucose Intervention | Experimental | 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, for insulin adjustments (Control-Intervention Group). Receives: Device: POC Glucose Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)
Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).
Measured: 8 weeks (after completion of both phases)
Secondary outcomes (9)
% Time in Target Range (70-180 mg/dl)
% time in target range (70-180 mg/dl) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).
Measured: 8 weeks (after completion of both phases)
Mean % Time in Hypoglycemia (< 54 mg/dL)
% time in hypoglycemia (<54 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Measured: 8 weeks (after completion of both phases)
% Time in Hyperglycemia (>180 mg/dL)
% time in hyperglycemia (>180 mg/dL) during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Measured: 8 weeks (after completion of both phases)
% Time in Hyperglycemia (>250 mg/dl)
% time in hyperglycemia (>250 mg/dL) during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Measured: 8 weeks (after completion of both phases)
Glycemic Variability [% Coefficient of Variation (%CV)
% coefficient of variation will be measured during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Measured: 8 weeks (after completion of both phases)
Mean Amplitude of Glucose Excursions (MAGE)
Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Measured: 8 weeks (after completion of both phases)
HbA1C at 3 Months Follow up
HbA1C at 3 months follow up from baseline. Data will be exported from the electronic medical records.
Measured: Baseline, 3 months post-intervention
Number of Hospitalization or Emergency Room Visits for Hypoglycemia
Rate of hospitalization or emergency room (ER) visits for hypoglycemia will be recorded at baseline (including 1 year prior to the start of the study) and at 3 months post study intervention.
Measured: Baseline, 3 months post-intervention
Number of Hospitalization or Emergency Room Visits for Diabetes Ketoacidosis (DKA)
Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded at baseline (including 1 year prior to the start of the study) and at 3 months post study intervention.
Measured: Baseline, 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start5 Nov 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model 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; and vice versa (Control-Intervention Group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo Galindo, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473430
- Sponsor's protocol ID
- IRB00114840
- Other IDs
- MH121653, 1K23DK123384-01
- Status last verified
- Jan 2025
- First submitted
- 13 Jul 2020
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04473430
- Acronym / sponsor ID
- IRB00114840
- Conditions
- End-Stage Renal Disease, Type 2 Diabetes
- Keywords
- ESRD, Continuous Glucose Monitoring, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model 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; and vice versa (Control-Intervention Group).
| Arm | Type | Receives |
|---|---|---|
| Real-time Dexcom CGM during CGM Intervention | Experimental | Device: Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM)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, for insulin adjustments. |
| Professional Dexcom CGM During Point-Of-Care Blood Glucose Intervention | Experimental | Device: POC Glucose TestingPatients 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, for insulin adjustments (Control-Intervention Group). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult subjects with type 2 diabetes
- receiving hemodialysis (for at least 90 days)
- treated with insulin therapy [basal insulin alone (glargine U100, glargine U300, detemir, 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).
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM)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. 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). Diagnostic Test: Real-time CGM will be used to collect outcomes variables | Device | Real-time Dexcom CGM during CGM Intervention |
| POC Glucose TestingPOC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations. Diagnostic Test: Professional CGM will be used to collect outcomes variables (including during the POC BG testing). | Device | Professional Dexcom CGM During Point-Of-Care Blood Glucose Intervention |
Primary outcome
Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)
Time frame: 8 weeks (after completion of both phases)
Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM. Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).
9 secondary outcomes
% Time in Target Range (70-180 mg/dl)
Time frame: 8 weeks (after completion of both phases)
Mean % Time in Hypoglycemia (< 54 mg/dL)
Time frame: 8 weeks (after completion of both phases)
% Time in Hyperglycemia (>180 mg/dL)
Time frame: 8 weeks (after completion of both phases)
% Time in Hyperglycemia (>250 mg/dl)
Time frame: 8 weeks (after completion of both phases)
Glycemic Variability [% Coefficient of Variation (%CV)
Time frame: 8 weeks (after completion of both phases)
Mean Amplitude of Glucose Excursions (MAGE)
Time frame: 8 weeks (after completion of both phases)
HbA1C at 3 Months Follow up
Time frame: Baseline, 3 months post-intervention
Number of Hospitalization or Emergency Room Visits for Hypoglycemia
Time frame: Baseline, 3 months post-intervention
Number of Hospitalization or Emergency Room Visits for Diabetes Ketoacidosis (DKA)
Time frame: Baseline, 3 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared
Related trials for End-Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Umpierrez, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM) and POC Glucose Testing in people with End-Stage Renal Disease and Type 2 Diabetes, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL) (time frame: 8 weeks (after completion of both phases)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.