ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes

A study testing MDI and AHCL in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes
What is being tested?: MDI and AHCL
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 14 sitesin 3 countries
Study dates: 13 Jul 2020to 30 May 2022
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

Subject is age ≥ 18 years old at time of screening
Subject has a clinical diagnosis of Type 1 diabetes for ≥ 2 years prior to screening as determined via source documentation
On MDI therapy (defined as ≥ 3 insulin injections per day and/or a basal/bolus regimen) ≥ 2 years prior to screening
Subject has been followed and treated by the investigator at this investigational site for at least 3 months prior to screening and subject has already undergone local educational therapeutic programs.
Subject is using:
Flash Glucose Monitoring (FGM) for ≥ 3 months with a daily average number of scans ≥ 5 over and with sensor readings > 70% of time over the previous month prior to screening (based on sensor usage from the download summary report of the FGM system over 30 days prior to screening) Or

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Continuous Glucose Monitoring (CGM) for ≥ 3 months with a frequency of sensor use ≥ 70% of the time over the previous month prior to screening (based on download summary report from the CGM system over 30 days prior to screening).
Subject has a glycosylated hemoglobin (HbA1c) ≥ 8.0% (64 mmol/mol) at time of screening visit (as processed by a Central Lab).
Subject is willing to take or switch to one of the following insulins:
Humalog™ (insulin lispro injection)
NovoLog™ (insulin aspart)
Subject must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 8 units and a maximum of 250 units.
Subject is willing to upload data from the study pump and meter, must have Internet access and a compatible computer system that meets the requirements for uploading the study pump data at home.
Subject is willing and able to sign and date informed consent, comply with all study procedures and wear all study devices, as required during the study.

Who cannot join

Subject has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
Subject is using pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin, SGLT2 inhibitors at time of screening.
Subject has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 12 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft or MDRD equations.
Subject is planning to switch from FGM to CGM therapy during the 6 months study phase. Note: Subject randomized to Control Arm should remain on their current FGM or CGM therapy during the study phase and will be switched to AHCL during the continuation phase.
Subject has a history of hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.

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Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study, per investigator judgment.
Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
Subject is legally incompetent, illiterate or vulnerable person.
Research staff involved with the study.

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

France6 sites

Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
Besançon
CHU de Bordeaux - Hôpital Saint André
Bordeaux
CHU Caen
Caen
Hospices Civils de Lyon (DIAB-e CARE)
Lyon
APM - Hôpital de la Conception
Marseille
Hospital Civil
Strasbourg

Other trials in France

Germany4 sites

Diabetologische Schwerpunktpraxis Dr. Ralf Kolassa
Bergheim
Zentrum für Diabetologie Bergedorf
Hamburg
Gemeinschaftspraxis im Westtor Hausarztpraxis & Diabetologische Schwerpunktpraxis
Lage
Medical Center am Clemenshospital Dr. Winfried Keuthage
Münster

Other trials in Germany

United Kingdom4 sites

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge
Harrogate and District Hospital - NHS Foundation Trust
Harrogate
University Hospitals of Leicester NHS Trust Leicester General Hospital
Leicester
King's College Hospital NHS Foundation Trust
London

Other trials in United Kingdom

About this study

Read the detailed description

This study is a pre-market, multi-center, prospective, open label, adaptative, randomized controlled trial in insulin-requiring adult subjects with type 1 diabetes on MDI therapy. The study will have three period:

Run-in Phase: The Run-in period is of 4 weeks (and can be extended for 2 additional ones) during which time a blinded CGM sensor will be worn for two weeks.
Study Phase: There will be a 6 months randomized study period with two arms: Treatment Arm (AHCL) and the Control Arm.
Continuation Phase: There will be a 6 months continuation phase during which time all the subjects will use the AHCL system.

Approximately 124 subjects will be enrolled in the study up to 20 investigational centers in EMEA.

Conditions: Type 1 Diabetes
Being tested: MDI, AHCL
Keywords: Advanced Hybrid Closed Loop, Multiple Daily Injections, Flash Glucose Monitoring, Continuous Glucose Monitoring
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MDIOther
Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM
AHCLDevice
Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0.
Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.

Study groups in NCT04235504
Study group	Role	What they receive
Control Arm	Active comparator	The Control Arm will use individual subject's current diabetes therapy (MDI+FGM or MDI+CGM) for 6 months during the Study Phase. During the Continuation Phase of 6 months Control Arm will start using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0 Receives: Other: MDI; Device: AHCL
Treatment Arm	Experimental	The Treatment Arm will use the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0 for 6 months during the Study Phase and other 6 months during the Continuation Phase. Receives: Device: AHCL

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c 6 Months Change Between AHCL and MDI
The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).
Measured: Baseline and end of 6-month study phase

Secondary outcomes (3)

TIR Between 70-180 mg/dL
% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).
Measured: 6 months study phase
Time in Hyperglycemic Range
% Time spent in hyperglycemic range with SG > 180 mg/dL (> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).
Measured: 6 months study phase
Hypoglycemic Events
Number of biochemical hypoglycemic events< 54 mg/dL (3.0 mmol/L) (defined as sensor values < 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A)
Measured: 6 months study phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 202030 May 2022

First posted22 Jan 2020
Study start13 Jul 2020
Primary completion2 Dec 2021
Study completion30 May 2022

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 (4)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: There will be 2 Cohort for this study: 1. Cohort A: Subjects on MDI + FGM will be randomized into: Treatment Arm (AHCL) and Control Arm (MDI+ FGM) 2. Cohort B: Subjects on MDI + Real-Time CGM will be randomized into: Treatment Arm (AHCL) and Control Arm (MDI+ CGM) (exploratory analysis)
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04235504
Sponsor's protocol ID: CIP327
Acronym: ADAPT
Status last verified: Mar 2023
First submitted: 16 Jan 2020
Last updated: 27 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Jendle J, Buompensiere MI, Ozdemir Saltik AZ, de Portu S, Smith-Palmer J, Pollock RF, Cohen O. A European Cost-Utility Analysis of the MiniMed 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2023 Dec;25(12):864-876. doi: 10.1089/dia.2023.0297.
PubMed 37801658
Edd SN, Castaneda J, Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, Cellot J, de Portu S, Vorrink L, Shin J, van den Heuvel T, Cohen O; ADAPT study Group. Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes. Diabetes Obes Metab. 2023 Nov;25(11):3212-3222. doi: 10.1111/dom.15217. Epub 2023 Aug 8.
PubMed 37551542
Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, de Portu S, Vorrink L, Shin J, Habteab A, Castaneda J, da Silva J, Cohen O; ADAPT study Group. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):720-731. doi: 10.1016/S2213-8587(22)00212-1. Epub 2022 Sep 1.
PubMed 36058207
de Portu S, Vorrink L, Re R, Shin J, Castaneda J, Habteab A, Cohen O. Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale. BMJ Open. 2022 Feb 2;12(2):e050635. doi: 10.1136/bmjopen-2021-050635.
PubMed 35110310

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04235504
Acronym / sponsor ID: ADAPT / CIP327
Conditions: Type 1 Diabetes
Keywords: Advanced Hybrid Closed Loop, Multiple Daily Injections, Flash Glucose Monitoring, Continuous Glucose Monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: 13 Jul 2020 (actual)
Primary completion: 2 Dec 2021 (actual)
Study completion: 30 May 2022 (actual)
First posted: 22 Jan 2020 (actual)
Results: Posted 9 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Run-in Phase: The Run-in period is of 4 weeks (and can be extended for 2 additional ones) during which time a blinded CGM sensor will be worn for two weeks.
Study Phase: There will be a 6 months randomized study period with two arms: Treatment Arm (AHCL) and the Control Arm.
Continuation Phase: There will be a 6 months continuation phase during which time all the subjects will use the AHCL system.

Approximately 124 subjects will be enrolled in the study up to 20 investigational centers in EMEA.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: There will be 2 Cohort for this study: 1. Cohort A: Subjects on MDI + FGM will be randomized into: Treatment Arm (AHCL) and Control Arm (MDI+ FGM) 2. Cohort B: Subjects on MDI + Real-Time CGM will be randomized into: Treatment Arm (AHCL) and Control Arm (MDI+ CGM) (exploratory analysis)

Arm	Type	Receives
Control Arm	Active comparator	Other: MDI, Device: AHCLThe Control Arm will use individual subject's current diabetes therapy (MDI+FGM or MDI+CGM) for 6 months during the Study Phase. During the Continuation Phase of 6 months Control Arm will start using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0
Treatment Arm	Experimental	Device: AHCLThe Treatment Arm will use the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0 for 6 months during the Study Phase and other 6 months during the Continuation Phase.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Subject is age ≥ 18 years old at time of screening
Subject has a clinical diagnosis of Type 1 diabetes for ≥ 2 years prior to screening as determined via source documentation
On MDI therapy (defined as ≥ 3 insulin injections per day and/or a basal/bolus regimen) ≥ 2 years prior to screening
Subject has been followed and treated by the investigator at this investigational site for at least 3 months prior to screening and subject has already undergone local educational therapeutic programs.
Subject is using:

Key exclusion criteria (13 listed)

Subject has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
Subject is using pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin, SGLT2 inhibitors at time of screening.
Subject has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 12 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft or MDRD equations.
Subject is planning to switch from FGM to CGM therapy during the 6 months study phase. Note: Subject randomized to Control Arm should remain on their current FGM or CGM therapy during the study phase and will be switched to AHCL during the continuation phase.
Subject has a history of hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.

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
MDISubject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM	Other	Control Arm
AHCLSubject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0. Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.	Device	Control Arm, Treatment Arm

Primary outcome

HbA1c 6 Months Change Between AHCL and MDI
Time frame: Baseline and end of 6-month study phase
The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).

3 secondary outcomes

TIR Between 70-180 mg/dL
Time frame: 6 months study phase
Time in Hyperglycemic Range
Time frame: 6 months study phase
Hypoglycemic Events
Time frame: 6 months study phase

Results and safety

Results posted to the registry on 9 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A - Treatment Arm	41	36
Cohort A - Control Arm	41	39
Cohort B - Treatment Arm	8	8
Cohort B - Control Arm	5	5

Primary outcome: HbA1c 6 Months Change Between AHCL and MDI

Time frame: Baseline and end of 6-month study phase. Mean (Standard Error). Unit: Percentage of HbA1c

Measure	Cohort A - Treatment Arm n = 36	Cohort A - Control Arm n = 38
Value	-1.54 (0.729)	-0.20 (0.797)

Cohort A - Treatment Arm vs Cohort A - Control Arm: Mean Difference (Final Values): -1.42 (95% CI -1.74 to -1.10), p <0.0001, linear mixed model

Population analysed: Study phase: 82 subjects in Cohort A. 74 subjects have available measurements.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A Run-in Phase	1 of 105 (1%)	21 of 105 (20%)	0 of 105
Cohort B Run-in Phase	1 of 17 (5.9%)	1 of 17 (5.9%)	0 of 17
Cohort A - Treatment Arm Study Phase	1 of 41 (2.4%)	19 of 41 (46.3%)	0 of 41
Cohort A - Control Arm Study Phase	1 of 41 (2.4%)	18 of 41 (43.9%)	0 of 41
Cohort B - Treatment Arm Study Phase	1 of 8 (12.5%)	2 of 8 (25%)	0 of 8
Cohort B - Control Arm Study Phase	0 of 5 (0%)	0 of 5 (0%)	0 of 5
All Patients Continuation Phase	2 of 88 (2.3%)	31 of 88 (35.2%)	0 of 88

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37801658Jendle J, Buompensiere MI, Ozdemir Saltik AZ, de Portu S, Smith-Palmer J, Pollock RF, Cohen O. A European Cost-Utility Analysis of the MiniMed 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2023 Dec;25(12):864-876. doi: 10.1089/dia.2023.0297.
Derived from this study: PubMed 37551542Edd SN, Castaneda J, Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, Cellot J, de Portu S, Vorrink L, Shin J, van den Heuvel T, Cohen O; ADAPT study Group. Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes. Diabetes Obes Metab. 2023 Nov;25(11):3212-3222. doi: 10.1111/dom.15217. Epub 2023 Aug 8.
Derived from this study: PubMed 36058207Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, Re R, de Portu S, Vorrink L, Shin J, Habteab A, Castaneda J, da Silva J, Cohen O; ADAPT study Group. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):720-731. doi: 10.1016/S2213-8587(22)00212-1. Epub 2022 Sep 1.
Derived from this study: PubMed 35110310de Portu S, Vorrink L, Re R, Shin J, Castaneda J, Habteab A, Cohen O. Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale. BMJ Open. 2022 Feb 2;12(2):e050635. doi: 10.1136/bmjopen-2021-050635.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes

Active, not recruitingPhase 3
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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.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MDI and AHCL in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 14 sites in 3 countries.

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 14 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France, Germany, United Kingdom. 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 9 Mar 2023). 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?

HbA1c 6 Months Change Between AHCL and MDI (time frame: Baseline and end of 6-month study phase). 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 NCT04235504, which also lists 4 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 27 Mar 2023; AzTrials last refreshed its copy on 2 Nov 2026.