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| ID | Type | Description | Link |
|---|---|---|---|
| MH121653 | Other Identifier | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |
| 1K23DK123384-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks (after completion of both phases) |
| Measure | Description | Time Frame |
|---|---|---|
| % 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic | Atlanta | Georgia | 30322 | United States | ||
| Grady Health System (non-CRN) |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared
Start 6 months after publication End 12 months after publication
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.
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Of the 66 individuals who signed the informed consent form (ICF), 53 took part in the study. The remaining 13 individuals did not proceed to the study due to screening failure. Therefore, the following tables include data only from the 53 participants who began the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Real-time Dexcom CGM During CGM Intervention, Then Professional Dexcom CGM During POC Intervention | 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. Dexcom real-time G6 CGM System: 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. It 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. It 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase I (First Intervention - 4 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2022 |
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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).
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| POC Glucose Testing | Device | 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). |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 3 months post-intervention |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| FG001 | Professional Dexcom CGM During POC Intervention, Then Real-time Dexcom CGM During CGM Intervention | 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). Intervention: 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: CGM will be used to collect outcomes variables during each phase (including during the POC BG testing). |
| COMPLETED |
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| NOT COMPLETED |
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| Phase II (Second Intervention - 4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received either Real-time Dexcom CGM Intervention or POC-BG Intervention first, and then switch to the remaining intervention after a 2 week wash out period. 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Population analyzed per group included patients with usable data. | Posted | Mean | Standard Deviation | percentage of time in hypoglycemia | 8 weeks (after completion of both phases) |
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| Secondary | % 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). | Population analyzed per group included patients with usable data. | Posted | Mean | Standard Deviation | percentage of time in target range | 8 weeks (after completion of both phases) |
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| Secondary | 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. | Population analyzed per group included patients with usable data. | Posted | Mean | Standard Deviation | percentage of time in hypoglycemia | 8 weeks (after completion of both phases) |
| ||||||||||||||||||||||||||||||
| Secondary | % 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. | Population analyzed per group included patients with usable data. | Posted | Mean | Standard Deviation | percentage of time in hyperglycemia | 8 weeks (after completion of both phases) |
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| Secondary | % 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. | Population analyzed per group included patients with usable data. | Posted | Mean | Standard Deviation | percentage of time in hyperglycemia | 8 weeks (after completion of both phases) |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Population analyzed per group included patients with usable data. | Posted | Mean | Standard Deviation | percentage of coefficient of variation | 8 weeks (after completion of both phases) |
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| Secondary | 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. | Population analyzed per group included patients with usable data. | Posted | Mean | Standard Deviation | mg/dL | 8 weeks (after completion of both phases) |
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| Secondary | HbA1C at 3 Months Follow up | HbA1C at 3 months follow up from baseline. Data will be exported from the electronic medical records. | Per standard of care, HbA1c was not repeated during the RCT before the three-month follow-up of the study (it was not collected by the dialysis center). | Posted | Mean | Standard Deviation | percent of RBCs with glycated hemoglobin | Baseline, 3 months post-intervention |
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| Secondary | 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. | Participants did not stay in the study for 3 months. Hence, data at 3 months was not possible to be collected by the dialysis center. | Posted | Number | number of events | Baseline, 3 months post-intervention |
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| Secondary | 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. | Participants did not stay in the study for 3 months. Hence, data at 3 months was not possible to be collected by the dialysis center. | Posted | Number | events | Baseline, 3 months post-intervention |
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Through study completion, an average of 2.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real-time Dexcom CGM | Patients with type 2 DM treated with insulin and receiving hemodialysis used a real-time/personal CGM for 4 weeks | 0 | 39 | 0 | 39 | 4 | 39 |
| EG001 | Professional Dexcom CGM (Blinded) | Patients with type 2 DM treated with insulin and receiving hemodialysis used POC BG for 4 weeks | 0 | 39 | 0 | 39 | 4 | 39 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic Hypoglycemia <70mg/dl | Endocrine disorders | Non-systematic Assessment |
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| Symptomatic Hypoglycemia <54mg/dl | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rodolfo Galindo | University of Miami | 305-284-3781 | rodolfo.galindo@miami.edu |
| Sep 12, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2023 | Apr 25, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Unknown or Not Reported |
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| OG001 | Professional Dexcom CGM (Blinded) | 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). Intervention: 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: CGM will be used to collect outcomes variables during each phase (including during the POC BG testing). |
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| OG001 | Professional Dexcom CGM (Blinded) | 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). Intervention: 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: CGM will be used to collect outcomes variables during each phase (including during the POC BG testing). |
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| OG001 | Professional Dexcom CGM (Blinded) | 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). Intervention: 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: CGM will be used to collect outcomes variables during each phase (including during the POC BG testing). |
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| OG001 | Professional Dexcom CGM (Blinded) | 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). Intervention: 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: CGM will be used to collect outcomes variables during each phase (including during the POC BG testing). |
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| OG001 | Professional Dexcom CGM (Blinded) | 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). Intervention: 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: CGM will be used to collect outcomes variables during each phase (including during the POC BG testing). |
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| OG001 | Professional Dexcom CGM (Blinded) | 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). Intervention: 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: CGM will be used to collect outcomes variables during each phase (including during the POC BG testing). |
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