DiabetesNCT04094064
Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).
A study testing Continuous Glucose Monitor in people with Diabetes and Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
Trial summary
Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread. CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Continuous Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 29 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18+
- Type 1 diabetes mellitus on intermittent HD thrice weekly OR Type 2 diabetes mellitus on intermittent HD thrice weekly
- Willingness and ability to comply with scheduled visits and study procedures
Who cannot join
- Inability to comply with finger stick blood glucoses at least four times daily
- Noncompliant with HD therapies
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread. CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. Patients with end stage renal disease (ESRD) who are on intermittent hemodialysis (iHD) or peritoneal dialysis (PD) undergo fluid shifts between the interstitial fluid and intravascular space during dialysis treatments.These fluid shifts, uremia, acidosis, and volume overload (increase in interstitial fluid volume due to ESRD) have the potential to impact the performance of the most advanced and commercially available CGMs; however, use of CGM in these patients has not yet been studied.Use of CGM, and potentially hybrid closed loop insulin delivery systems that are dependent on accurate continuous glucose monitoring, has the potential to improve glucose control and quality of life in these patients (7). This study team feels that this study will be valuable in collecting preliminary data needed with the goal of validating the use of CGM in this patient population. The specific aim is to conduct a pilot study to evaluate the accuracy of continuous glucose monitors (CGM) in End Stage Renal Disease (ESRD) patients on intermittent hemodialysis (iHD).
Read the detailed description
Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread (1). CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. The probe is an electroenzymatic sensor which uses glucose oxidase to break down glucose to create hydrogen peroxidase and other elements. Hydrogen peroxidase then interacts with a base metal layer of the sensor and is oxidized, which results in release of electrons which creates a current. The current is proportional to the glucose concentration. The current is measured by the probe and transmits a calculated glucose concentration to a receiving device (2). Substances that are widely distributed in body water, and thereby present in the interstitial space, potentially affect this technology. Acetaminophen and aspirin are substances that are have been known to affect the accuracy of these devices (3); however, more recently developed CGMs such as the Dexcom G6, were able to demonstrate no interference by acetaminophen (4). Patients with end stage renal disease (ESRD) who are on intermittent hemodialysis (iHD) or peritoneal dialysis (PD) undergo fluid shifts between the interstitial fluid and intravascular space during dialysis treatments. They are also often uremic and have metabolic acidosis (5). These fluid shifts, uremia, acidosis, and volume overload (increase in interstitial fluid volume due to ESRD) have the potential to impact the performance of the most advanced and commercially available CGMs; however, use of CGM in these patients has not yet been studied (3). Moderate to severe CKD is associated with both increase in insulin resistance and decrease in insulin clearance, which results in often unpredictable and labile glucose concentrations and increased risk of hypoglycemia in these patients (6). Use of CGM, and potentially hybrid closed loop insulin delivery systems that are dependent on accurate continuous glucose monitoring, has the potential to improve glucose control and quality of life in these patients (7). This study team feels that this study will be valuable in collecting preliminary data needed with the goal of validating the use of CGM in this patient population.OBJECTIVE: The specific aim is to conduct a pilot study to evaluate the accuracy of continuous glucose monitors (CGM) in End Stage Renal Disease (ESRD) patients on intermittent hemodialysis (iHD). Accuracy will be assessed by calculating the mean absolute relative difference (MARD) between CGM values and concurrent finger stick or capillary blood glucose (CBG) in these patients during hemodialysis, and on non-dialysis days.
- Being tested
- Continuous Glucose Monitor
- Keywords
- Dialysis, Hemodialysis, Diabetes, Continuous Glucose Monitor (CGM)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Use of a continuous glucose monitor during study period.
| Study group | Role | What they receive |
|---|---|---|
| CGM Use while on Hemodialysis Therapy | Experimental | All subjects will use a CGM for 10 days. Subjects will continue their standard of care hemodialysis treatments during the study period. Receives: Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG])
Mean Absolute Relative Difference (MARD) between CGM value and capillary blood glucose (SMBG) performed at home 4 to 7 times per day by the participant for 684 matched pairs.
Measured: From CGM placement to CGM removal (10 days)
Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM)
Venous blood glucose samples were collected approximately 12 blood samples from the existing hemodialysis (HD) intravenous (IV) line during each (three) HD session the CGM sensor was worn. These blood samples were immediately processed using the i-STAT System. While the goal was to have the subject participate in three hemodialysis sessions, two sessions were acceptable. 624 matched data pairs were analyzed.
Measured: From CGM placement to CGM removal (10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start19 Feb 2020
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Meaghan Stumpf, MD, University of Virginia
- Investigators
- Meaghan Stumpf, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094064
- Sponsor's protocol ID
- 190012
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2019
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no current plans to share IPD for this study.
Publications
Villard O, Breton MD, Rao S, Voelmle MK, Fuller MR, Myers HE, McFadden RK, Luke ZS, Wakeman CA, Clancy-Oliveri M, Basu A, Stumpf MM. Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis. Diabetes Care. 2022 Jul 7;45(7):1666-1669. doi: 10.2337/dc22-0073.
PubMed 35485908
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of Continuous Glucose Monitoring (CGM) in Patients With End Stage Renal Disease (ESRD) on Intermittent Hemodialysis (iHD).
- ClinicalTrials.gov ID
- NCT04094064
- Acronym / sponsor ID
- 190012
- Keywords
- Dialysis, Hemodialysis, Diabetes, Continuous Glucose Monitor (CGM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Posted 21 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread. CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. Patients with end stage renal disease (ESRD) who are on intermittent hemodialysis (iHD) or peritoneal dialysis (PD) undergo fluid shifts between the interstitial fluid and intravascular space during dialysis treatments.These fluid shifts, uremia, acidosis, and volume overload (increase in interstitial fluid volume due to ESRD) have the potential to impact the performance of the most advanced and commercially available CGMs; however, use of CGM in these patients has not yet been studied.Use of CGM, and potentially hybrid closed loop insulin delivery systems that are dependent on accurate continuous glucose monitoring, has the potential to improve glucose control and quality of life in these patients (7). This study team feels that this study will be valuable in collecting preliminary data needed with the goal of validating the use of CGM in this patient population. The specific aim is to conduct a pilot study to evaluate the accuracy of continuous glucose monitors (CGM) in End Stage Renal Disease (ESRD) patients on intermittent hemodialysis (iHD).
Detailed description
Recent advances in continuous glucose monitors (CGMs) and availability of commercial CGM products to patients with type 1 and type 2 diabetes has made the use of CGM more widespread (1). CGMs work by placing a probe underneath the skin of a patient, into the interstitial space. The probe is an electroenzymatic sensor which uses glucose oxidase to break down glucose to create hydrogen peroxidase and other elements. Hydrogen peroxidase then interacts with a base metal layer of the sensor and is oxidized, which results in release of electrons which creates a current. The current is proportional to the glucose concentration. The current is measured by the probe and transmits a calculated glucose concentration to a receiving device (2). Substances that are widely distributed in body water, and thereby present in the interstitial space, potentially affect this technology. Acetaminophen and aspirin are substances that are have been known to affect the accuracy of these devices (3); however, more recently developed CGMs such as the Dexcom G6, were able to demonstrate no interference by acetaminophen (4). Patients with end stage renal disease (ESRD) who are on intermittent hemodialysis (iHD) or peritoneal dialysis (PD) undergo fluid shifts between the interstitial fluid and intravascular space during dialysis treatments. They are also often uremic and have metabolic acidosis (5). These fluid shifts, uremia, acidosis, and volume overload (increase in interstitial fluid volume due to ESRD) have the potential to impact the performance of the most advanced and commercially available CGMs; however, use of CGM in these patients has not yet been studied (3). Moderate to severe CKD is associated with both increase in insulin resistance and decrease in insulin clearance, which results in often unpredictable and labile glucose concentrations and increased risk of hypoglycemia in these patients (6). Use of CGM, and potentially hybrid closed loop insulin delivery systems that are dependent on accurate continuous glucose monitoring, has the potential to improve glucose control and quality of life in these patients (7). This study team feels that this study will be valuable in collecting preliminary data needed with the goal of validating the use of CGM in this patient population.OBJECTIVE: The specific aim is to conduct a pilot study to evaluate the accuracy of continuous glucose monitors (CGM) in End Stage Renal Disease (ESRD) patients on intermittent hemodialysis (iHD). Accuracy will be assessed by calculating the mean absolute relative difference (MARD) between CGM values and concurrent finger stick or capillary blood glucose (CBG) in these patients during hemodialysis, and on non-dialysis days.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM Use while on Hemodialysis Therapy | Experimental | Device: Continuous Glucose MonitorAll subjects will use a CGM for 10 days. Subjects will continue their standard of care hemodialysis treatments during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18+
- Type 1 diabetes mellitus on intermittent HD thrice weekly OR Type 2 diabetes mellitus on intermittent HD thrice weekly
- Willingness and ability to comply with scheduled visits and study procedures
Key exclusion criteria (3 listed)
- Inability to comply with finger stick blood glucoses at least four times daily
- Noncompliant with HD therapies
- Pregnant women
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 |
|---|---|---|
| Continuous Glucose MonitorUse of a continuous glucose monitor during study period. | Device | CGM Use while on Hemodialysis Therapy |
Primary outcome
Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG])
Time frame: From CGM placement to CGM removal (10 days)
Mean Absolute Relative Difference (MARD) between CGM value and capillary blood glucose (SMBG) performed at home 4 to 7 times per day by the participant for 684 matched pairs.
Mean Absolute Relative Difference (MARD) Between Continuous Glucose Monitor (CGM) Value and Venous Blood Glucose (vBGM)
Time frame: From CGM placement to CGM removal (10 days)
Venous blood glucose samples were collected approximately 12 blood samples from the existing hemodialysis (HD) intravenous (IV) line during each (three) HD session the CGM sensor was worn. These blood samples were immediately processed using the i-STAT System. While the goal was to have the subject participate in three hemodialysis sessions, two sessions were acceptable. 624 matched data pairs were analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35485908Villard O, Breton MD, Rao S, Voelmle MK, Fuller MR, Myers HE, McFadden RK, Luke ZS, Wakeman CA, Clancy-Oliveri M, Basu A, Stumpf MM. Accuracy of a Factory-Calibrated Continuous Glucose Monitor in Individuals With Diabetes on Hemodialysis. Diabetes Care. 2022 Jul 7;45(7):1666-1669. doi: 10.2337/dc22-0073.
- Individual participant dataSharing planned: No. There are no current plans to share IPD for this study.
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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.
Meaghan Stumpf, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor in people with Diabetes and Diabetes Mellitus, Type 1, run by University of Virginia at 1 site 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 3 inclusion and 3 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 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 21 Dec 2022). 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?
Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG]) (time frame: From CGM placement to CGM removal (10 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094064, which also lists 1 linked publication.
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 21 Dec 2022.