Type 1 DiabetesRocketAPNCT04545567
Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes
A study testing RocketAP and USS Virginia in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
Trial summary
The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM). Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- RocketAP and USS Virginia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2020to 21 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥12.0 and ≤25 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Currently using insulin for at least six months
- Currently using insulin pump for at least three months
- Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
- Access to internet and willingness to upload data during the study as needed
Show all 16Show fewer
- For females, not currently known to be pregnant or breastfeeding
- If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Willingness to use the UVa artificial pancreas system throughout study sessions.
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission
- Willingness to reschedule Study Dinner Sessions if placed on oral steroids
- An understanding and willingness to follow the protocol and signed informed consent
Who cannot join
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently being treated for a seizure disorder
- Planned surgery during study duration
- Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22904
About this study
Official title: Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes (Rocket AP)
The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM).
Read the detailed description
Maintaining blood glucose (BG) control among adolescents with Type 1 diabetes (T1D) is arguably the greatest challenge in the entire field of T1D. One reason for this poor control relates to missed meal boluses, which affects 65% of adolescents at least once weekly, with 38% missing at least 15% of their boluses. Adolescents who miss four boluses weekly experience an increase of 1% in their HbA1c. While the advent of the artificial pancreas (AP) offers promise of safe reductions in HbA1c, the study team previously found that the AP only partly compensates for missed prandial insulin -demonstrating that some form of meal announcement is necessary for good BG control, even with an AP. One way to automate this process is by sharing the prandial dosing responsibilities between an automated insulin priming (based on continuous glucose monitor condition predictive of a safe situation for such insulin dosing) and a closed loop controller capable of reconstructing (estimating) the prevailing glucose rate of appearance from an unannounced meal. The study team has developed such an insulin priming schema and integrated it into a new version of the robust Model Predictive Controller University of Virginia AP system (called the RocketAP).
In the current study, the investigators are testing this new AP system in two configurations: hybrid and fully automated, among up to 20 adolescents. The primary outcome will be one of efficacy in assessing how well the new system controls post-prandial BG in the absence of carbohydrate (CHO) announcement as compared to the same situation but using the Control-IQ closed loop algorithm, also designed at UVa and using the same modular architecture and safety system, but without insulin priming and with a less advanced model-based controller. Further comparisons will be made to BG control on RocketAP with CHO announcement and on Control-IQ with CHO announcement. Adolescents will be started on the respective University of Virginia AP systems (RocketAP and Control-IQ in random order, both implemented on the DiAs platform, MAF 2109) and followed over the course of two dinners on each of the two platforms: a dinner where CHO is announced as normal and the 2nd where no announcement is made.
The study team hypothesize that performances of RocketAP in fully automated mode will lie in between Hybrid and Fully Automated Control-IQ. In time, this may provide an opportunity to improve BG control among adolescents who miss meal announcement.
- Conditions
- Type 1 Diabetes
- Being tested
- RocketAP, USS Virginia
- Keywords
- Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Insulin Pump, Closed Loop Control
- 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.
RocketAPDevice
Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal
USS VirginiaDevice
Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion
| Study group | Role | What they receive |
|---|---|---|
| RocketAP | Experimental | Adolescents will be assessed for a 48-70 hour period on the Rocket AP. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the USS Virginia system under the same conditions. Receives: Device: RocketAP |
| USS Virginia | Active comparator | Adolescents will be assessed for a 48-70 hour period on the USS Virginia system. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the Rocket AP system under the same conditions. Receives: Device: USS Virginia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal
Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal
Measured: 6 hours
Secondary outcomes (19)
Number of Hypoglycemia Events From Dinner Time Until Midnight
Number of hypoglycemia events from dinner time until midnight
Measured: 6 hours
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL
Measured: 6 hours
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL
Measured: 6 hours
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL
Measured: 6 hours
Units of Insulin Injected From Dinner Time Until Midnight
Units of insulin injected from dinner time until midnight
Measured: 6 hours
The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value
The blood glucose area under the curve (AUC) from dinner until midnight, accounting for the initial blood glucose value.
Measured: 6 hours
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL
Percentage of time from dinner time until dinner time + 12h with blood glucose in range 70-180 mg/dL
Measured: 12 hours
Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h
Number of hypoglycemia events from dinner Time until dinner time + 12h
Measured: 12 hours
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL
Percentage of time from dinner time until dinner time + 12h with blood Glucose in range <70 mg/dL
Measured: 12 hours
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL
Measured: 12 hours
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL
Measured: 12 hours
Units of Insulin Injected From Dinner Time Until Dinner Time + 12h
Units of insulin injected from dinner time until dinner time + 12h
Measured: 12 hours
The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value
The Blood Glucose Area Under the Curve (AUC) From Dinner Until dinner + 12h, Accounting for the Initial Blood Glucose Value
Measured: 12 hours
Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL
Percentage of Time outside the dinner sessions With Blood Glucose in Range 70-180 mg/dL
Measured: 36 hours
Number of Hypoglycemia Events Outside of the Study Dinner Sessions
Number of hypoglycemia events outside of the Study Dinner Sessions
Measured: 36 hours
Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL
Percentage of Time outside of the Study Dinner Sessions with Blood Glucose <70 mg/dL
Measured: 36 hours
Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL
Percent of Time Outside of the Study Dinner Sessions with Blood Glucose >180 mg/dL
Measured: 36 hours
Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL
Percent Time Outside of the Study Dinner Sessions with Blood Glucose >250 mg/dL
Measured: 36 hours
Units of Insulin Injected Outside of the Study Dinner Sessions
Units of insulin injected outside of the Study Dinner Sessions
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start16 Dec 2020
- Primary completion18 Jan 2021
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized cross-over trial assessing glycemic responses to two different approaches to insulin dosing for carbohydrate ingestion (announced vs. unannounced), with two different AP systems (RocketAP vs. USS Virginia, aka Control-IQ, in random order)
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark D. DeBoer, MD, MSc., MCR, University of Virginia
- Investigators
- Mark D DeBoer, MD, MSc, MCR, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545567
- Sponsor's protocol ID
- 200235
- Acronym
- RocketAP
- Status last verified
- Mar 2022
- First submitted
- 3 Sep 2020
- Last updated
- 20 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Pending
Publications
Garcia-Tirado J, Diaz JL, Esquivel-Zuniga R, Koravi CLK, Corbett JP, Dawson M, Wakeman C, Barnett CL, Oliveri MC, Myers H, Krauthause K, Breton MD, DeBoer MD. Advanced Closed-Loop Control System Improves Postprandial Glycemic Control Compared With a Hybrid Closed-Loop System Following Unannounced Meal. Diabetes Care. 2021 Aug 15:dc210932. doi: 10.2337/dc21-0932. Online ahead of print.
PubMed 34400480
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes (Rocket AP)
- ClinicalTrials.gov ID
- NCT04545567
- Acronym / sponsor ID
- RocketAP / 200235
- Conditions
- Type 1 Diabetes
- Keywords
- Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Insulin Pump, Closed Loop Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Posted 31 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM).
Detailed description
Maintaining blood glucose (BG) control among adolescents with Type 1 diabetes (T1D) is arguably the greatest challenge in the entire field of T1D. One reason for this poor control relates to missed meal boluses, which affects 65% of adolescents at least once weekly, with 38% missing at least 15% of their boluses. Adolescents who miss four boluses weekly experience an increase of 1% in their HbA1c. While the advent of the artificial pancreas (AP) offers promise of safe reductions in HbA1c, the study team previously found that the AP only partly compensates for missed prandial insulin -demonstrating that some form of meal announcement is necessary for good BG control, even with an AP. One way to automate this process is by sharing the prandial dosing responsibilities between an automated insulin priming (based on continuous glucose monitor condition predictive of a safe situation for such insulin dosing) and a closed loop controller capable of reconstructing (estimating) the prevailing glucose rate of appearance from an unannounced meal. The study team has developed such an insulin priming schema and integrated it into a new version of the robust Model Predictive Controller University of Virginia AP system (called the RocketAP).
In the current study, the investigators are testing this new AP system in two configurations: hybrid and fully automated, among up to 20 adolescents. The primary outcome will be one of efficacy in assessing how well the new system controls post-prandial BG in the absence of carbohydrate (CHO) announcement as compared to the same situation but using the Control-IQ closed loop algorithm, also designed at UVa and using the same modular architecture and safety system, but without insulin priming and with a less advanced model-based controller. Further comparisons will be made to BG control on RocketAP with CHO announcement and on Control-IQ with CHO announcement. Adolescents will be started on the respective University of Virginia AP systems (RocketAP and Control-IQ in random order, both implemented on the DiAs platform, MAF 2109) and followed over the course of two dinners on each of the two platforms: a dinner where CHO is announced as normal and the 2nd where no announcement is made.
The study team hypothesize that performances of RocketAP in fully automated mode will lie in between Hybrid and Fully Automated Control-IQ. In time, this may provide an opportunity to improve BG control among adolescents who miss meal announcement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized cross-over trial assessing glycemic responses to two different approaches to insulin dosing for carbohydrate ingestion (announced vs. unannounced), with two different AP systems (RocketAP vs. USS Virginia, aka Control-IQ, in random order)
| Arm | Type | Receives |
|---|---|---|
| RocketAP | Experimental | Device: RocketAPAdolescents will be assessed for a 48-70 hour period on the Rocket AP. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the USS Virginia system under the same conditions. |
| USS Virginia | Active comparator | Device: USS VirginiaAdolescents will be assessed for a 48-70 hour period on the USS Virginia system. This time will include two dinner times, one with and one without announcement of carbohydrate content. This is a cross-over study, so all participants will also be tested on the Rocket AP system under the same conditions. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Age ≥12.0 and ≤25 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Currently using insulin for at least six months
- Currently using insulin pump for at least three months
- Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
Key exclusion criteria (8 listed)
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently being treated for a seizure disorder
- Planned surgery during study duration
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 |
|---|---|---|
| RocketAPArtificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal | Device | RocketAP |
| USS VirginiaArtificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion | Device | USS Virginia |
Primary outcome
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal
Time frame: 6 hours
Percentage of time from dinner time until midnight with blood glucose in range 70-180 mg/dL in the unannounced meal
19 secondary outcomes
Number of Hypoglycemia Events From Dinner Time Until Midnight
Time frame: 6 hours
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL
Time frame: 6 hours
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL
Time frame: 6 hours
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL
Time frame: 6 hours
Units of Insulin Injected From Dinner Time Until Midnight
Time frame: 6 hours
The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value
Time frame: 6 hours
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL
Time frame: 12 hours
Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h
Time frame: 12 hours
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL
Time frame: 12 hours
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL
Time frame: 12 hours
Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL
Time frame: 12 hours
Units of Insulin Injected From Dinner Time Until Dinner Time + 12h
Time frame: 12 hours
The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value
Time frame: 12 hours
Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL
Time frame: 36 hours
Number of Hypoglycemia Events Outside of the Study Dinner Sessions
Time frame: 36 hours
Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL
Time frame: 36 hours
Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL
Time frame: 36 hours
Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL
Time frame: 36 hours
Units of Insulin Injected Outside of the Study Dinner Sessions
Time frame: 36 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34400480Garcia-Tirado J, Diaz JL, Esquivel-Zuniga R, Koravi CLK, Corbett JP, Dawson M, Wakeman C, Barnett CL, Oliveri MC, Myers H, Krauthause K, Breton MD, DeBoer MD. Advanced Closed-Loop Control System Improves Postprandial Glycemic Control Compared With a Hybrid Closed-Loop System Following Unannounced Meal. Diabetes Care. 2021 Aug 15:dc210932. doi: 10.2337/dc21-0932. Online ahead of print.
- Individual participant dataSharing planned: Yes. Pending
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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.
Mark D DeBoer, MD, MSc, MCR principal investigator
University of Virginia Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RocketAP and USS Virginia in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal (time frame: 6 hours). 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 NCT04545567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.