DiabetesNCT04230694
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes
A study testing Dexcom Generation 6 CGM (Dexcom Gen6) device in people with Diabetes and Diabetes Mellitus, run by Baylor Research Institute at 1 site in United States.
Trial summary
Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Glucose, High Blood
- What is being tested?
- Dexcom Generation 6 CGM (Dexcom Gen6) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 1 and Type 2 diabetes.
- Subjects 18 years of age or older with diabetes.
- Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day)
- Subjects with expected hospital length-of-stay of 2 or more days beyond the time of enrollment.
- Subjects willing to wear CGM device.
Who cannot join
- Female subjects who are pregnant or lactating at the time of enrollment into the study. Females with childbearing potential will be queried about the possibility of pregnancy and a serum pregnancy test will be performed.
- Subjects with greater than 4gm use of Tylenol/24 hr.
- Surgical patients or patients with pre-planned surgery or procedure in the next 48 hours.
- Subjects with acute illness admitted to the ICU or expected to require admission to the ICU.
- Patients who may potentially require IV insulin.
- Patients with skin lesions, severe psoriasis, burns, tattoos, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
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- Patient with a known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Patients who have had organ transplant.
- Patients with any severe medical conditions such as end-stage renal disease on dialysis, status post renal transplantation, end-stage liver disease with diffuse anasarca, heart failure on inotropic support, Ejection Fraction (EF) < 15 % or severe sepsis.
- Any condition for which, in the opinion of the investigators, it would not be in the best interest of the participant.
- Legally protected subjects (under judicial protection, guardianship, or supervision), persons deprived of their liberty, mental or language barriers rendering the subject unable to understand the nature, scope and possible consequences of the study.
- Subjects with active substance abuse.
- Subjects with infaust prognosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
About this study
Official title: Continuous Glucose Monitoring of Hospitalized Patients With Diabetes: A Pilot Study to Establish Evidence
Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been found to be helpful for reducing hypoglycemia in some studies while less so in others, however, these studies were performed with earlier generation glucose monitoring devices(5). ICU studies have confirmed accuracy of CGM measurements compared with capillary glucose even in settings with use of vasopressors and large-volume resuscitation. A limited number of studies have evaluated glycemic outcomes in the inpatient non-ICU setting. Studies of non-ICU patients (6-10) are limited by very small sample size, short study duration, and use of older CGM devices. There is, therefore, a critical need to systematically investigate the use of CGM in the inpatient care of patients with diabetes mellitus who are receiving care in a hospital setting that is typical of inpatient care.
Read the detailed description
AIM
- Test the health impact of CGM of inpatients as defined by rates of hypo- and hyperglycemia and the derivative of time in appropriate glucose range. Forty (40) patients will be randomized 1:1 into one of two conditions. In the treatment condition, patients will receive a Dexcom Gen6 device and the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will be trained to use readings from the Dexcom Gen6 for the management of the patient's glucose levels below 100. In the control condition, patients will receive a Dexcom Gen6 device, but the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will not have access to the readings and will provide usual care (four glucose checks per 24 hours and use of insulin or other diabetic agent ordered by the admitting and rounding providers to determine glucose management).
- Hypothesis 1: Patients in the treatment condition will experience fewer episodes of hypoglycemia as compared to patients in the control condition as measured by the Dexcom Gen6 readings.
- Hypothesis 2: Patients in the treatment condition will experience less frequent hyperglycemia events as compared to patients in the control condition as measured by the Dexcom Gen6 readings.
- Conditions
- Diabetes, Diabetes Mellitus, Glucose, High Blood, Glucose, Low Blood
- Being tested
- Dexcom Generation 6 CGM (Dexcom Gen6) device
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom Generation 6 CGM (Dexcom Gen6) deviceDevice
Also called CGM
Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Control Group subjects will wear the CGM device during their hospitalization, up to 10 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay. Receives: Device: Dexcom Generation 6 CGM (Dexcom Gen6) device |
| Treatment Group | Experimental | Treatment Group subjects will wear the CGM device during their hospitalization, up to 10 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks. Receives: Device: Dexcom Generation 6 CGM (Dexcom Gen6) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hypoglycemia Events during hospitalization
Dexcom Gen6 readings
Measured: Up to 10 days
Secondary outcomes (1)
Number of Hyperglycemia Events during hospitalization
Dexcom Gen6 readings
Measured: Up to 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 Jan 2020
- Study start20 Sep 2021
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dexcom Generation 6 CGM (Dexcom Gen6) device
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tresa McNeal, MD, Principal investigator, Baylor Scott & White Medical Center - Temple
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230694
- Sponsor's protocol ID
- 018-601
- Status last verified
- Jul 2024
- First submitted
- 13 Jan 2020
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share individual participant data
Publications
Levetan CS, Passaro M, Jablonski K, Kass M, Ratner RE. Unrecognized diabetes among hospitalized patients. Diabetes Care. 1998 Feb;21(2):246-9. doi: 10.2337/diacare.21.2.246.
PubMed 9539990Mendez CE, Mok KT, Ata A, Tanenberg RJ, Calles-Escandon J, Umpierrez GE. Increased glycemic variability is independently associated with length of stay and mortality in noncritically ill hospitalized patients. Diabetes Care. 2013 Dec;36(12):4091-7. doi: 10.2337/dc12-2430. Epub 2013 Oct 29.
PubMed 24170754Curkendall SM, Natoli JL, Alexander CM, Nathanson BH, Haidar T, Dubois RW. Economic and clinical impact of inpatient diabetic hypoglycemia. Endocr Pract. 2009 May-Jun;15(4):302-12. doi: 10.4158/EP08343.OR.
PubMed 19502209Rubin DJ, Golden SH. Hypoglycemia in non-critically ill, hospitalized patients with diabetes: evaluation, prevention, and management. Hosp Pract (1995). 2013 Feb;41(1):109-16. doi: 10.3810/hp.2013.02.1016.
PubMed 23466973van Steen SC, Rijkenberg S, Limpens J, van der Voort PH, Hermanides J, DeVries JH. The Clinical Benefits and Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients-A Systematic Scoping Review. Sensors (Basel). 2017 Jan 14;17(1):146. doi: 10.3390/s17010146.
PubMed 28098809Gomez AM, Umpierrez GE, Munoz OM, Herrera F, Rubio C, Aschner P, Buendia R. Continuous Glucose Monitoring Versus Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin Regimen. J Diabetes Sci Technol. 2015 Aug 31;10(2):325-9. doi: 10.1177/1932296815602905.
PubMed 26330394Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.
PubMed 25927357Levitt DL, Silver KD, Spanakis EK. Inpatient Continuous Glucose Monitoring and Glycemic Outcomes. J Diabetes Sci Technol. 2017 Sep;11(5):1028-1035. doi: 10.1177/1932296817698499. Epub 2017 Mar 14.
PubMed 28290224Levitt DL, Silver KD, Spanakis EK. Mitigating Severe Hypoglycemia by Initiating Inpatient Continuous Glucose Monitoring for Type 1 Diabetes Mellitus. J Diabetes Sci Technol. 2017 Mar;11(2):440-441. doi: 10.1177/1932296816664538. Epub 2016 Aug 20. No abstract available.
PubMed 27543272Spanakis EK, Levitt DL, Siddiqui T, Singh LG, Pinault L, Sorkin J, Umpierrez GE, Fink JC. The Effect of Continuous Glucose Monitoring in Preventing Inpatient Hypoglycemia in General Wards: The Glucose Telemetry System. J Diabetes Sci Technol. 2018 Jan;12(1):20-25. doi: 10.1177/1932296817748964. Epub 2017 Dec 13.
PubMed 29237288Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. doi: 10.1186/1477-7525-5-57.
PubMed 17927832Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring of Hospitalized Patients With Diabetes: A Pilot Study to Establish Evidence
- ClinicalTrials.gov ID
- NCT04230694
- Acronym / sponsor ID
- 018-601
- Conditions
- Diabetes, Diabetes Mellitus, Glucose, High Blood, Glucose, Low Blood
- Keywords
- diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Jan 2020 (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.
Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been found to be helpful for reducing hypoglycemia in some studies while less so in others, however, these studies were performed with earlier generation glucose monitoring devices(5). ICU studies have confirmed accuracy of CGM measurements compared with capillary glucose even in settings with use of vasopressors and large-volume resuscitation. A limited number of studies have evaluated glycemic outcomes in the inpatient non-ICU setting. Studies of non-ICU patients (6-10) are limited by very small sample size, short study duration, and use of older CGM devices. There is, therefore, a critical need to systematically investigate the use of CGM in the inpatient care of patients with diabetes mellitus who are receiving care in a hospital setting that is typical of inpatient care.
Detailed description
AIM
- Test the health impact of CGM of inpatients as defined by rates of hypo- and hyperglycemia and the derivative of time in appropriate glucose range. Forty (40) patients will be randomized 1:1 into one of two conditions. In the treatment condition, patients will receive a Dexcom Gen6 device and the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will be trained to use readings from the Dexcom Gen6 for the management of the patient's glucose levels below 100. In the control condition, patients will receive a Dexcom Gen6 device, but the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will not have access to the readings and will provide usual care (four glucose checks per 24 hours and use of insulin or other diabetic agent ordered by the admitting and rounding providers to determine glucose management).
- Hypothesis 1: Patients in the treatment condition will experience fewer episodes of hypoglycemia as compared to patients in the control condition as measured by the Dexcom Gen6 readings.
- Hypothesis 2: Patients in the treatment condition will experience less frequent hyperglycemia events as compared to patients in the control condition as measured by the Dexcom Gen6 readings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dexcom Generation 6 CGM (Dexcom Gen6) device
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Dexcom Generation 6 CGM (Dexcom Gen6) deviceControl Group subjects will wear the CGM device during their hospitalization, up to 10 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay. |
| Treatment Group | Experimental | Device: Dexcom Generation 6 CGM (Dexcom Gen6) deviceTreatment Group subjects will wear the CGM device during their hospitalization, up to 10 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Type 1 and Type 2 diabetes.
- Subjects 18 years of age or older with diabetes.
- Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day)
- Subjects with expected hospital length-of-stay of 2 or more days beyond the time of enrollment.
- Subjects willing to wear CGM device.
Key exclusion criteria (13 listed)
- Female subjects who are pregnant or lactating at the time of enrollment into the study. Females with childbearing potential will be queried about the possibility of pregnancy and a serum pregnancy test will be performed.
- Subjects with greater than 4gm use of Tylenol/24 hr.
- Surgical patients or patients with pre-planned surgery or procedure in the next 48 hours.
- Subjects with acute illness admitted to the ICU or expected to require admission to the ICU.
- Patients who may potentially require IV insulin.
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 Generation 6 CGM (Dexcom Gen6) deviceAlso: CGMStanding orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings. | Device | Control Group, Treatment Group |
Primary outcome
Number of Hypoglycemia Events during hospitalization
Time frame: Up to 10 days
Dexcom Gen6 readings
1 secondary outcome
Number of Hyperglycemia Events during hospitalization
Time frame: Up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 9539990Levetan CS, Passaro M, Jablonski K, Kass M, Ratner RE. Unrecognized diabetes among hospitalized patients. Diabetes Care. 1998 Feb;21(2):246-9. doi: 10.2337/diacare.21.2.246.
- Background: PubMed 24170754Mendez CE, Mok KT, Ata A, Tanenberg RJ, Calles-Escandon J, Umpierrez GE. Increased glycemic variability is independently associated with length of stay and mortality in noncritically ill hospitalized patients. Diabetes Care. 2013 Dec;36(12):4091-7. doi: 10.2337/dc12-2430. Epub 2013 Oct 29.
- Background: PubMed 19502209Curkendall SM, Natoli JL, Alexander CM, Nathanson BH, Haidar T, Dubois RW. Economic and clinical impact of inpatient diabetic hypoglycemia. Endocr Pract. 2009 May-Jun;15(4):302-12. doi: 10.4158/EP08343.OR.
- Background: PubMed 23466973Rubin DJ, Golden SH. Hypoglycemia in non-critically ill, hospitalized patients with diabetes: evaluation, prevention, and management. Hosp Pract (1995). 2013 Feb;41(1):109-16. doi: 10.3810/hp.2013.02.1016.
- Background: PubMed 28098809van Steen SC, Rijkenberg S, Limpens J, van der Voort PH, Hermanides J, DeVries JH. The Clinical Benefits and Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients-A Systematic Scoping Review. Sensors (Basel). 2017 Jan 14;17(1):146. doi: 10.3390/s17010146.
- Background: PubMed 26330394Gomez AM, Umpierrez GE, Munoz OM, Herrera F, Rubio C, Aschner P, Buendia R. Continuous Glucose Monitoring Versus Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin Regimen. J Diabetes Sci Technol. 2015 Aug 31;10(2):325-9. doi: 10.1177/1932296815602905.
- Background: PubMed 25927357Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.
- Background: PubMed 28290224Levitt DL, Silver KD, Spanakis EK. Inpatient Continuous Glucose Monitoring and Glycemic Outcomes. J Diabetes Sci Technol. 2017 Sep;11(5):1028-1035. doi: 10.1177/1932296817698499. Epub 2017 Mar 14.
- Background: PubMed 27543272Levitt DL, Silver KD, Spanakis EK. Mitigating Severe Hypoglycemia by Initiating Inpatient Continuous Glucose Monitoring for Type 1 Diabetes Mellitus. J Diabetes Sci Technol. 2017 Mar;11(2):440-441. doi: 10.1177/1932296816664538. Epub 2016 Aug 20. No abstract available.
- Background: PubMed 29237288Spanakis EK, Levitt DL, Siddiqui T, Singh LG, Pinault L, Sorkin J, Umpierrez GE, Fink JC. The Effect of Continuous Glucose Monitoring in Preventing Inpatient Hypoglycemia in General Wards: The Glucose Telemetry System. J Diabetes Sci Technol. 2018 Jan;12(1):20-25. doi: 10.1177/1932296817748964. Epub 2017 Dec 13.
- Background: PubMed 17927832Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. doi: 10.1186/1477-7525-5-57.
- Background: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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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.
Tresa McNeal, MD principal investigator
Baylor Scott & White Medical Center - Temple
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom Generation 6 CGM (Dexcom Gen6) device in people with Diabetes and Diabetes Mellitus, run by Baylor Research Institute 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 5 inclusion and 13 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 17 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Hypoglycemia Events during hospitalization (time frame: Up to 10 days). 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 NCT04230694, which also lists 12 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 17 Apr 2026.