Type1 Diabetes MellitusNCT05928260
Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus
A study testing Medtronic Guardian Connect Sensor 3, Abott Freestyle Libre Sensor and Self blood Glucose monitoring by a glucometer in people with Type1 Diabetes Mellitus, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Type 1 Diabetes Mellitus (T1DM) is characterized by absolute insulin deficiency. Despite multiple daily insulin injections, glycemic targets are usually not achieved in T1DM patients.Use of continuos glucose monitoring system (CGMS) is associated with improvement in glycemic control and reduction in glycemic… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Medtronic Guardian Connect Sensor 3, Abott Freestyle Libre Sensor and Self blood Glucose monitoring by a glucometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 10 Aug 2023to Mar 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents and adults aged 15-40 years with Type-1 Diabetes mellitus defined by any of the following; i. Diabetic Ketoacidosis or ketonemia or ketonuria at diagnosis with insulin dependence for survival since diagnosis OR ii. Insulin dependence for survival since diagnosis and any one of the following autoantibody positivity: GAD-65 or IA-2
- Patients on Basal bolus regimen (Glargine as basal and lispro /Aspart /Glulisine as bolus);
- Duration of Diabetes > 2 years;
- Insulin dose requirement of at least 0.5U/kg
- HbA1c 8%-12%;
- Gold score<4;
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- No previous experience with rt-CGMS and/or is-CGMS;
- Euthyroid status;
- If hypothyroid, then on stable dose of Levothyroxine for last 3 months with normal T4 level;
- Urine albumin creatinine ratio<300 mg/g of Creatinine;
- Those willing to give informed consent prior to enrolment.
Who cannot join
- LADA or Secondary Diabetes
- eGFR<60ml/min/1.73m2
- Celiac disease;
- Hb<12g/dl for males and <11g/dl for females;
- Hypoglycemia unawareness defined by Gold score≥4;
- HbA1c>12%;
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- Diabetic Ketoacidosis in the previous 3 months;
- Severe Non proliferative Diabetic retinopathy/Proliferative Diabetic Retinopathy/Macular edema;
- Pregnancy;
- Lactation;
- Willing to become pregnant during study;
- Requiring MRI for any existing condition;
- Any other chronic illness.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
Sanjay Bhadada, DM Endo, +919876602448, bhadadask@rediffmail.com
About this study
Official title: Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus: an Open Label Randomised Control Cross Over Study
Type 1 Diabetes Mellitus (T1DM) is characterized by absolute insulin deficiency. Despite multiple daily insulin injections, glycemic targets are usually not achieved in T1DM patients.Use of continuos glucose monitoring system (CGMS) is associated with improvement in glycemic control and reduction in glycemic variability in T1DM subjects. real-time CGMS (rt-CGMS) and intermittently scanned CGMS (is-CGMS) are the newer CGMS technologies. Previous studies have shown that in T1DM patients rt-CGMS is better than is-CGMS for glycemic control and reducing hypoglycemic episodes in patients with impaired awareness of hypoglycemia, but in patients with normal hypoglycemic awareness this is not well established.
This study is a randomized control clinical cross over study of 6 months duration in patients of T1DM having normal hypoglycemic awareness, with age 15-40 years with a HbA1c range of 8-12%. Following a training period of 2 weeks, 80 participants will be randomized into 3 arms in a ratio of 1:1:2 in rt-CGMS, is-CGMS and SMBG (self monitoring of blood glucose) arms, respectively. For the first two groups Medtronic Guardian Connect Sensor 3 and Abott Freestyle Libre Sensor 2will be applied for 2 weeks, respectively; followed by a crossover at 3 months withapplication of is-CGMS and rt-CGMS, respectively in these groups for a further 2 weeks period. For rest of the study duration these patients in the rt-CGMS and is-CGMS group will be monitored through SMBG. The 3rd SMBG group will act as control. Short term blood glucose control will be assessed by Fructosamine assay in the 2 CGMS groups and long term control by HbA1C.
Read the detailed description
Type 1 Diabetes Mellitus (T1DM) is characterized by absolute insulin deficiency. Despite multiple daily insulin injections, glycemic targets are usually not achieved in T1DM patients. Use of continuos glucose monitoring system (CGMS) is associated with improvement in glycemic control and reduction in glycemic variability in T1DM subjects. Real-time CGMS (rt-CGMS) and intermittently Scanned CGMS (is-CGMS) are the newer CGMS technologies. Previous studies have shown that in T1DM patients rt-CGMS is better than is-CGMS for glycemic control and reducing hypoglycemic episodes in patients with impaired awareness of hypoglycemia, but in patients with normal hypoglycemic awareness this is not well established.
This study is a randomized control clinical study of 6 months duration in patients of T1DM having normal hypoglycemic awareness, with age 15-40 years with a HbA1c range of 8-12%. Following a training period of 2 weeks, 80 participants will be randomized into 3 arms in a ratio of 1:1: 2 into rt-CGMS, is-CGMS arms and SMBG(Self Monitoring of Blood Glucose) arms respectively. For the rt-CGMS group Medtronic Guardian Connect sensor 3 will be applied for 2 weeks and and for is-CGMS group Free Style Libre will be applied for 2 weeks. The participants randomized into the 3rd group shall do self monitoring of blood glucose(SMBG) throughout the study duration of 6 months. Those participants randomized into rt-CGMS and is-CGMS groups after the end of 2 weeks will also monitor their blood glucose by SMBG till the end of 3 months.The frequency of SMBG for all these groups would be - 4 times a day( premeal blood glucose and one post meal blood glucose on rotational basis) on weekdays and 7 times on Sundays(3 times pre meals, 3 times 2 hrs post meals and once at 3 am). At the end of 3 months participants in the rt-CGMS group will undergo crossover to is-CGMS group and vice versa whereas participants in SMBG group will remain in the same arm till the end of the study(6 months).Short term blood glucose control will be assessed by Fructosamine assay after 2 weeks of CGMS application and long term control by HbA1C at the end of 3 months and 6 months. All glycemic parameters(like Time in Range, Time below Range and Time in Range will be compared in both CGMS groups before and after cross-over and both these arms will be compared with SMBG for all the outcomes.Quality of life will also be assessed in these groups by using QOLID questionnaire.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Medtronic Guardian Connect Sensor 3, Abott Freestyle Libre Sensor, Self blood Glucose monitoring by a glucometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Guardian Connect Sensor 3Device
This is a real-time CGMS which transmits all the blood glucose readings into the application downloaded in a device continuously and also gives alarms and alerts to the person.
Abott Freestyle Libre SensorDevice
This system is an is-CGMS in which the participant gets his blood glucose only when the device is scanned.
Self blood Glucose monitoring by a glucometerOther
In this all patients will check their blood glucose using a needle prick and glucometer at pre-specified intervals.
| Study group | Role | What they receive |
|---|---|---|
| Real time CGMS(rt-CGMS) | Active comparator | Medtronic Guardian Connect sensor 3 will be applied for 2 weeks at the beginning of this study in this arm for blood glucose monitoring and insulin dose adjustments for glycemic control. Receives: Device: Medtronic Guardian Connect Sensor 3 |
| Intermittently scanned CGMS(is-CGMS) | Active comparator | Abott Freestyle Libre Sensor will be applied for 2 weeks at the beginning of this study in this arm for blood glucose monitoring and insulin dose adjustments for glycemic control. Receives: Device: Abott Freestyle Libre Sensor |
| Self Monitoring of Blood Glucose(SMBG) | Placebo comparator | This group will monitor blood glucose using glucometer and needle pricks throughout the study duration and insulin doses will be adjusted based on these readings as per the standard management of Type-1 Diabetes Mellitus patients endorsed by American Diabetic Association in 2023. Receives: Other: Self blood Glucose monitoring by a glucometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Composite outcome of blood glucose control over the preceding 3 months at time=3 months from the start of the study, It will be measured in % using VARIANTII TURBO Hemoglobin Testing System- Bio Rad.
Measured: 3 months
Secondary outcomes (7)
HbA1c
Composite outcome of blood glucose control over the preceding 3 months at time=6months from the start of the study.It will be measured in % using VARIANTII TURBO Hemoglobin Testing System- Bio Rad.
Measured: 6 months
Fructosamine levels in the CGMS groups
- before the application of Ist device and immediately after the end of 2 weeks at the beginning of the study and at the time of crossover(3 months from the start of the study)immediately before and after 2 weeks of application of 2nd device. This will be done only in rt-CGMS and is-CGMS arms.It will be measured in micromole per litre using Roche cobas FRA colorimetric system in the plasma with a measuring range between 14-1000 micromole per litre.
Measured: At baseline , 2 weeks, 3 months and 3 months 2 weeks.
Mean sensor glucose
Assessment of mean glucose in mg/dl will be done from the CGMS i.e. from the Medtronic Guardian Connect Sensor 3 in the real-time CGMS group and from the Abott Free Style Libre Sensor intermittently-scanned CGMS group.
Measured: After the first device(2 weeks) and after 2nd device(3 months 2 weeks)
Standard deviation of Sensor Glucose
It is a measure of deviation of blood glucose values from the mean which will be obtained from blood glucose readings from the CGMS i.e. from the Medtronic Guardian Connect Sensor 3 in the real-time CGMS group and from the Abott Free Style Libre Sensor intermittently-scanned CGMS group. It will be measured in mg/dl in both the real time-CGMS and intermittently scanned CGMS groups.
Measured: After the first device(2 weeks) and after 2nd device(3 months 2 weeks)
Coefficient of Variation(CV)
It is a measure of blood glucose variability over a period of time derived from the Mean blood glucose and Standard Deviation of blood glucose obtained from the CGMS, it will be measured as percentage from the CGM sensor i.e. from the Medtronic Guardian Connect Sensor 3 in the real-time CGMS group and from the Abott Free Style Libre Sensor intermittently-scanned CGMS group.Higher the coefficient of variation more is the risk for microvascular complications of diabetes.Stable blood glucose should have Coefficient of Variation <36%.
Measured: After the first device(2 weeks) and after 2nd device(3 months 2 weeks)
Median Amplitude of Glycemic Excursions(MAGE)
It is the arithmetic mean of the amplitude of the blood glucose excursions that are greater than the Standard Deviation of the glucose values. It is calculated from the blood glucose values provided from the CGMS i.e. from the Medtronic Guardian Connect Sensor 3 in the real-time CGMS group and from the Abott Free Style Libre Sensor intermittently-scanned CGMS group.It is measured in millimoles per litre and will be calculated in both real-time CGMS and intermittently scanned CGMS groups using Easy GV software.
Measured: After the first device(2 weeks) and after 2nd device(3 months 2 weeks)
Quality of Life
This will be assessed in all the 3 groups using Quality of Life Instrument for Indian Diabetes Patients(QOLID) questionnaire. It consists of 34 items covering eight domains with scores as below. It uses a standard Likert scale across all questions.Minimum possible overall score is 34 and maximum possible overallscore is 175.Details as follows- role limitation due to physical health (6 - 30); physical endurance (6 - 30); general health (3 - 15); treatment satisfaction (4 - 20); symptom frequency ( 3 - 15); financial worries ( 4 - 20); mental health ( 5 - 25) and diet advice satisfaction( 3 - 15). Higher the score better the quality of life in that domain.
Measured: At Baseline and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Aug 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay K. Bhadada, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ashish Gupta, MD, Internal Medicine, Study director, Senior Resident Academic DM, Department of Endocrinology, PGIMER, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928260
- Sponsor's protocol ID
- 2649-01/2023
- Status last verified
- Aug 2023
- First submitted
- 30 May 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Real-time CGMS With Intermittently-scanned CGMS in Adolescents and Adults With Type 1 Diabetes Mellitus: an Open Label Randomised Control Cross Over Study
- ClinicalTrials.gov ID
- NCT05928260
- Acronym / sponsor ID
- 2649-01/2023
- Conditions
- Type1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
Type 1 Diabetes Mellitus (T1DM) is characterized by absolute insulin deficiency. Despite multiple daily insulin injections, glycemic targets are usually not achieved in T1DM patients.Use of continuos glucose monitoring system (CGMS) is associated with improvement in glycemic control and reduction in glycemic variability in T1DM subjects. real-time CGMS (rt-CGMS) and intermittently scanned CGMS (is-CGMS) are the newer CGMS technologies. Previous studies have shown that in T1DM patients rt-CGMS is better than is-CGMS for glycemic control and reducing hypoglycemic episodes in patients with impaired awareness of hypoglycemia, but in patients with normal hypoglycemic awareness this is not well established.
This study is a randomized control clinical cross over study of 6 months duration in patients of T1DM having normal hypoglycemic awareness, with age 15-40 years with a HbA1c range of 8-12%. Following a training period of 2 weeks, 80 participants will be randomized into 3 arms in a ratio of 1:1:2 in rt-CGMS, is-CGMS and SMBG (self monitoring of blood glucose) arms, respectively. For the first two groups Medtronic Guardian Connect Sensor 3 and Abott Freestyle Libre Sensor 2will be applied for 2 weeks, respectively; followed by a crossover at 3 months withapplication of is-CGMS and rt-CGMS, respectively in these groups for a further 2 weeks period. For rest of the study duration these patients in the rt-CGMS and is-CGMS group will be monitored through SMBG. The 3rd SMBG group will act as control. Short term blood glucose control will be assessed by Fructosamine assay in the 2 CGMS groups and long term control by HbA1C.
Detailed description
Type 1 Diabetes Mellitus (T1DM) is characterized by absolute insulin deficiency. Despite multiple daily insulin injections, glycemic targets are usually not achieved in T1DM patients. Use of continuos glucose monitoring system (CGMS) is associated with improvement in glycemic control and reduction in glycemic variability in T1DM subjects. Real-time CGMS (rt-CGMS) and intermittently Scanned CGMS (is-CGMS) are the newer CGMS technologies. Previous studies have shown that in T1DM patients rt-CGMS is better than is-CGMS for glycemic control and reducing hypoglycemic episodes in patients with impaired awareness of hypoglycemia, but in patients with normal hypoglycemic awareness this is not well established.
This study is a randomized control clinical study of 6 months duration in patients of T1DM having normal hypoglycemic awareness, with age 15-40 years with a HbA1c range of 8-12%. Following a training period of 2 weeks, 80 participants will be randomized into 3 arms in a ratio of 1:1: 2 into rt-CGMS, is-CGMS arms and SMBG(Self Monitoring of Blood Glucose) arms respectively. For the rt-CGMS group Medtronic Guardian Connect sensor 3 will be applied for 2 weeks and and for is-CGMS group Free Style Libre will be applied for 2 weeks. The participants randomized into the 3rd group shall do self monitoring of blood glucose(SMBG) throughout the study duration of 6 months. Those participants randomized into rt-CGMS and is-CGMS groups after the end of 2 weeks will also monitor their blood glucose by SMBG till the end of 3 months.The frequency of SMBG for all these groups would be - 4 times a day( premeal blood glucose and one post meal blood glucose on rotational basis) on weekdays and 7 times on Sundays(3 times pre meals, 3 times 2 hrs post meals and once at 3 am). At the end of 3 months participants in the rt-CGMS group will undergo crossover to is-CGMS group and vice versa whereas participants in SMBG group will remain in the same arm till the end of the study(6 months).Short term blood glucose control will be assessed by Fructosamine assay after 2 weeks of CGMS application and long term control by HbA1C at the end of 3 months and 6 months. All glycemic parameters(like Time in Range, Time below Range and Time in Range will be compared in both CGMS groups before and after cross-over and both these arms will be compared with SMBG for all the outcomes.Quality of life will also be assessed in these groups by using QOLID questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real time CGMS(rt-CGMS) | Active comparator | Device: Medtronic Guardian Connect Sensor 3Medtronic Guardian Connect sensor 3 will be applied for 2 weeks at the beginning of this study in this arm for blood glucose monitoring and insulin dose adjustments for glycemic control. |
| Intermittently scanned CGMS(is-CGMS) | Active comparator | Device: Abott Freestyle Libre SensorAbott Freestyle Libre Sensor will be applied for 2 weeks at the beginning of this study in this arm for blood glucose monitoring and insulin dose adjustments for glycemic control. |
| Self Monitoring of Blood Glucose(SMBG) | Placebo comparator | Other: Self blood Glucose monitoring by a glucometerThis group will monitor blood glucose using glucometer and needle pricks throughout the study duration and insulin doses will be adjusted based on these readings as per the standard management of Type-1 Diabetes Mellitus patients endorsed by American Diabetic Association in 2023. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Adolescents and adults aged 15-40 years with Type-1 Diabetes mellitus defined by any of the following; i. Diabetic Ketoacidosis or ketonemia or ketonuria at diagnosis with insulin dependence for survival since diagnosis OR ii. Insulin dependence for survival since diagnosis and any one of the following autoantibody positivity: GAD-65 or IA-2
- Patients on Basal bolus regimen (Glargine as basal and lispro /Aspart /Glulisine as bolus);
- Duration of Diabetes > 2 years;
- Insulin dose requirement of at least 0.5U/kg
- HbA1c 8%-12%;
Key exclusion criteria (13 listed)
- LADA or Secondary Diabetes
- eGFR<60ml/min/1.73m2
- Celiac disease;
- Hb<12g/dl for males and <11g/dl for females;
- Hypoglycemia unawareness defined by Gold score≥4;
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 |
|---|---|---|
| Medtronic Guardian Connect Sensor 3This is a real-time CGMS which transmits all the blood glucose readings into the application downloaded in a device continuously and also gives alarms and alerts to the person. | Device | Real time CGMS(rt-CGMS) |
| Abott Freestyle Libre SensorThis system is an is-CGMS in which the participant gets his blood glucose only when the device is scanned. | Device | Intermittently scanned CGMS(is-CGMS) |
| Self blood Glucose monitoring by a glucometerIn this all patients will check their blood glucose using a needle prick and glucometer at pre-specified intervals. | Other | Self Monitoring of Blood Glucose(SMBG) |
Primary outcome
HbA1c
Time frame: 3 months
Composite outcome of blood glucose control over the preceding 3 months at time=3 months from the start of the study, It will be measured in % using VARIANTII TURBO Hemoglobin Testing System- Bio Rad.
7 secondary outcomes
HbA1c
Time frame: 6 months
Fructosamine levels in the CGMS groups
Time frame: At baseline , 2 weeks, 3 months and 3 months 2 weeks.
Mean sensor glucose
Time frame: After the first device(2 weeks) and after 2nd device(3 months 2 weeks)
Standard deviation of Sensor Glucose
Time frame: After the first device(2 weeks) and after 2nd device(3 months 2 weeks)
Coefficient of Variation(CV)
Time frame: After the first device(2 weeks) and after 2nd device(3 months 2 weeks)
Median Amplitude of Glycemic Excursions(MAGE)
Time frame: After the first device(2 weeks) and after 2nd device(3 months 2 weeks)
Quality of Life
Time frame: At Baseline and 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
Ashish Gupta, MD, Internal Medicine study director
Senior Resident Academic DM, Department of Endocrinology, PGIMER, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Guardian Connect Sensor 3, Abott Freestyle Libre Sensor and Self blood Glucose monitoring by a glucometer in people with Type1 Diabetes Mellitus, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 11 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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 India. 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. Some participants in this study may receive a placebo. 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 Sanjay Bhadada, DM Endo (+919876602448, bhadadask@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 months). 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 21 Aug 2023.