HemodialysisCONDORNCT05509881
Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
A study testing Continuous glucose monitoring (CGM) in people with Hemodialysis and Diabete Mellitus, run by University of California, Irvine at 1 site in United States.
Trial summary
This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hemodialysis, Diabete Mellitus, Continuous Glucose Monitoring
- What is being tested?
- Continuous glucose monitoring (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent
- Age ≥18 years old
- End-stage kidney disease status receiving in-center hemodialysis ≥4 weeks
- Type 1 or type 2 diabetes
- Actively performing self-monitored blood glucose (SMBG) testing for ≥4 weeks
- ≥70% compliance wearing continuous glucose monitoring (CGM) device during the pre-trial period
Who cannot join
- Inability to provide informed consent or comply with the study protocol
- Limited visual acuity
- Inability to wear CGM device
- Prior use of CGM
- Active pregnancy or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, Irvine
Orange, California, 92868
Connie Rhee, 312-420-8474, crhee@uci.edu
About this study
This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.
Read the detailed description
This is a parallel, two-arm randomized controlled trial comparing real-time CGM using Dexcom devices vs. usual care (self-monitored blood glucose 4-times/day) among 122 in-center hemodialysis patients with diabetes mellitus over a 12-week period. Our primary objective will be to determine the effects of CGM vs. usual care on glycemic control, defined by percent (%) of time in target glucose range (70-180 mg/dl). Our main and exploratory secondary objectives will be to determine the effects of CGM on CGM-indices of hypoglycemia, blood-based glycemic markers (HbA1c, glycated albumin, fructosamine), and patient-reported outcomes (health-related quality of life, diabetes distress, hypoglycemia fear). We will also evaluate feasibility endpoints by measuring CGM compliance during the intervention period and success/ease of implementing CGM training sessions among patients.
- Being tested
- Continuous glucose monitoring (CGM), Usual care (Self-monitored blood glucose)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring (CGM)Device
Patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices.
Usual care (Self-monitored blood glucose)Device
Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day.
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring (CGM) arm | Experimental | During the intervention period, patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices. Receives: Device: Continuous glucose monitoring (CGM) |
| Usual care arm | Active comparator | During the intervention period, patients in the usual care arm will conduct self-monitored blood glucose (SMBG) at least 4 times/day. At Weeks 6 and 12 of the intervention period, usual care arm patients will also undergo 10-days of blinded CGM data collection. Receives: Device: Usual care (Self-monitored blood glucose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) of time in target glucose range (70-180 mg/dl)
Ascertained by continous glucose monitoring
Measured: 12 weeks
Secondary outcomes (9)
Percent (%) of time spent in hypoglycemia (<70 mg/dl)
Ascertained by continous glucose monitoring
Measured: 12 weeks
Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)
Ascertained by continous glucose monitoring
Measured: 12 weeks
Glycemic variability
Ascertained by continous glucose monitoring
Measured: 12 weeks
Hemoglobin A1c level
Ascertained by blood test
Measured: 12 weeks
Fructosamine level
Ascertained by blood test
Measured: 12 weeks
Glycated albumin level
Ascertained by blood test
Measured: 12 weeks
Short Form 36 Survey Physical Component Summary Score
Ascertained by Short Form 36 Survey; Minimum-Maximum range is 0-100; Higher scores indicate better health-related quality of life
Measured: 12 weeks
Diabetes Distress Scale Survey Score
Ascertained by Diabetes Distress Scale Survey; Minimum-Maximum range is 1-6; Higher scores indicate higher states of distress
Measured: 12 weeks
Hypoglycemia Fear
Ascertained by Hypoglycemia Fear Survey II
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start12 Dec 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie Rhee, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509881
- Sponsor's protocol ID
- 1668
- Acronym
- CONDOR
- Status last verified
- Feb 2024
- First submitted
- 15 Aug 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rhee CM, Kalantar-Zadeh K, Tuttle KR. Novel approaches to hypoglycemia and burnt-out diabetes in chronic kidney disease. Curr Opin Nephrol Hypertens. 2022 Jan 1;31(1):72-81. doi: 10.1097/MNH.0000000000000756.
PubMed 34750332Narasaki Y, Park E, You AS, Daza A, Peralta RA, Guerrero Y, Novoa A, Amin AN, Nguyen DV, Price D, Kalantar-Zadeh K, Rhee CM. Continuous glucose monitoring in an end-stage renal disease patient with diabetes receiving hemodialysis. Semin Dial. 2021 Sep;34(5):388-393. doi: 10.1111/sdi.13009. Epub 2021 Aug 10.
PubMed 34378258Rhee CM, Kovesdy CP, Kalantar-Zadeh K. Glucose Homeostasis, Hypoglycemia, and the Burnt-Out Diabetes Phenomenon in Kidney Disease. Semin Nephrol. 2021 Mar;41(2):96-103. doi: 10.1016/j.semnephrol.2021.03.004.
PubMed 34140100Rhee CM, Kovesdy CP, You AS, Sim JJ, Soohoo M, Streja E, Molnar MZ, Amin AN, Abbott K, Nguyen DV, Kalantar-Zadeh K. Hypoglycemia-Related Hospitalizations and Mortality Among Patients With Diabetes Transitioning to Dialysis. Am J Kidney Dis. 2018 Nov;72(5):701-710. doi: 10.1053/j.ajkd.2018.04.022. Epub 2018 Jul 20.
PubMed 30037725Rhee CM, Kovesdy CP, Ravel VA, Streja E, Brunelli SM, Soohoo M, Sumida K, Molnar MZ, Brent GA, Nguyen DV, Kalantar-Zadeh K. Association of Glycemic Status During Progression of Chronic Kidney Disease With Early Dialysis Mortality in Patients With Diabetes. Diabetes Care. 2017 Aug;40(8):1050-1057. doi: 10.2337/dc17-0110. Epub 2017 Jun 7.
PubMed 28592525
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Dialysis Patients to Overcome Dysglycemia Trial
- ClinicalTrials.gov ID
- NCT05509881
- Acronym / sponsor ID
- CONDOR / 1668
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will investigate whether use of continuous glucose monitoring (CGM) vs. usual care with self-monitored blood glucose 1) enhances glycemic control, 2) reduces hypoglycemia risk, and 3) improves quality of life, diabetes distress, and fear of hypoglycemia in hemodialysis patients with diabetes mellitus.
Detailed description
This is a parallel, two-arm randomized controlled trial comparing real-time CGM using Dexcom devices vs. usual care (self-monitored blood glucose 4-times/day) among 122 in-center hemodialysis patients with diabetes mellitus over a 12-week period. Our primary objective will be to determine the effects of CGM vs. usual care on glycemic control, defined by percent (%) of time in target glucose range (70-180 mg/dl). Our main and exploratory secondary objectives will be to determine the effects of CGM on CGM-indices of hypoglycemia, blood-based glycemic markers (HbA1c, glycated albumin, fructosamine), and patient-reported outcomes (health-related quality of life, diabetes distress, hypoglycemia fear). We will also evaluate feasibility endpoints by measuring CGM compliance during the intervention period and success/ease of implementing CGM training sessions among patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring (CGM) arm | Experimental | Device: Continuous glucose monitoring (CGM)During the intervention period, patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices. |
| Usual care arm | Active comparator | Device: Usual care (Self-monitored blood glucose)During the intervention period, patients in the usual care arm will conduct self-monitored blood glucose (SMBG) at least 4 times/day. At Weeks 6 and 12 of the intervention period, usual care arm patients will also undergo 10-days of blinded CGM data collection. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to provide written informed consent
- Age ≥18 years old
- End-stage kidney disease status receiving in-center hemodialysis ≥4 weeks
- Type 1 or type 2 diabetes
- Actively performing self-monitored blood glucose (SMBG) testing for ≥4 weeks
Key exclusion criteria (5 listed)
- Inability to provide informed consent or comply with the study protocol
- Limited visual acuity
- Inability to wear CGM device
- Prior use of CGM
- Active pregnancy or planning a pregnancy
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 monitoring (CGM)Patients in the CGM arm will undergo continuous real-time "unblinded" CGM using Dexcom CGM devices. | Device | Continuous glucose monitoring (CGM) arm |
| Usual care (Self-monitored blood glucose)Patients in the usual care arm will conduct self-monitored blood glucose at least 4 times/day. | Device | Usual care arm |
Primary outcome
Percent (%) of time in target glucose range (70-180 mg/dl)
Time frame: 12 weeks
Ascertained by continous glucose monitoring
9 secondary outcomes
Percent (%) of time spent in hypoglycemia (<70 mg/dl)
Time frame: 12 weeks
Percent (%) of time spent in relative hypoglycemia (<100 mg/dl)
Time frame: 12 weeks
Glycemic variability
Time frame: 12 weeks
Hemoglobin A1c level
Time frame: 12 weeks
Fructosamine level
Time frame: 12 weeks
Glycated albumin level
Time frame: 12 weeks
Short Form 36 Survey Physical Component Summary Score
Time frame: 12 weeks
Diabetes Distress Scale Survey Score
Time frame: 12 weeks
Hypoglycemia Fear
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 34750332Rhee CM, Kalantar-Zadeh K, Tuttle KR. Novel approaches to hypoglycemia and burnt-out diabetes in chronic kidney disease. Curr Opin Nephrol Hypertens. 2022 Jan 1;31(1):72-81. doi: 10.1097/MNH.0000000000000756.
- Background: PubMed 34378258Narasaki Y, Park E, You AS, Daza A, Peralta RA, Guerrero Y, Novoa A, Amin AN, Nguyen DV, Price D, Kalantar-Zadeh K, Rhee CM. Continuous glucose monitoring in an end-stage renal disease patient with diabetes receiving hemodialysis. Semin Dial. 2021 Sep;34(5):388-393. doi: 10.1111/sdi.13009. Epub 2021 Aug 10.
- Background: PubMed 34140100Rhee CM, Kovesdy CP, Kalantar-Zadeh K. Glucose Homeostasis, Hypoglycemia, and the Burnt-Out Diabetes Phenomenon in Kidney Disease. Semin Nephrol. 2021 Mar;41(2):96-103. doi: 10.1016/j.semnephrol.2021.03.004.
- Background: PubMed 30037725Rhee CM, Kovesdy CP, You AS, Sim JJ, Soohoo M, Streja E, Molnar MZ, Amin AN, Abbott K, Nguyen DV, Kalantar-Zadeh K. Hypoglycemia-Related Hospitalizations and Mortality Among Patients With Diabetes Transitioning to Dialysis. Am J Kidney Dis. 2018 Nov;72(5):701-710. doi: 10.1053/j.ajkd.2018.04.022. Epub 2018 Jul 20.
- Background: PubMed 28592525Rhee CM, Kovesdy CP, Ravel VA, Streja E, Brunelli SM, Soohoo M, Sumida K, Molnar MZ, Brent GA, Nguyen DV, Kalantar-Zadeh K. Association of Glycemic Status During Progression of Chronic Kidney Disease With Early Dialysis Mortality in Patients With Diabetes. Diabetes Care. 2017 Aug;40(8):1050-1057. doi: 10.2337/dc17-0110. Epub 2017 Jun 7.
- Individual participant dataSharing planned: No
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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.
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 monitoring (CGM) in people with Hemodialysis and Diabete Mellitus, run by University of California, Irvine 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Connie Rhee (714-456-5142, crhee1@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent (%) of time in target glucose range (70-180 mg/dl) (time frame: 12 weeks). 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 NCT05509881, which also lists 5 linked publications.
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 28 Feb 2024.