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Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes (RocketAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545567
Recruitment Status : Completed
First Posted : September 11, 2020
Last Update Posted : November 1, 2021
Sponsor:
Collaborator:
University of Virginia Launchpad for Diabetes
Information provided by (Responsible Party):
Mark D. DeBoer, MD, MSc., MCR, University of Virginia

Tracking Information
First Submitted Date  ICMJE September 3, 2020
First Posted Date  ICMJE September 11, 2020
Last Update Posted Date November 1, 2021
Actual Study Start Date  ICMJE December 16, 2020
Actual Primary Completion Date January 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2020)
time in range 70-180 mg/dL from dinner time until midnight [ Time Frame: 6 hours ]
time in range 70-180 mg/dL from dinner time until midnight
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2020)
  • Number of hypoglycemia events beginning after dinner and for 6h thereafter [ Time Frame: 6 hours ]
    Number of hypoglycemia events beginning after dinner and for 6h thereafter
  • Time <70 mg/dL beginning after dinner and for 6h thereafter [ Time Frame: 6 hours ]
    Time <70 mg/dL beginning after dinner and for 6h thereafter
  • Time >180 mg/dL beginning after dinner and for 6h thereafter [ Time Frame: 6 hours ]
    Time >180 mg/dL beginning after dinner and for 6h thereafter
  • Time >250 mg/dL beginning after dinner and for 6h thereafter [ Time Frame: 6 hours ]
    Time >250 mg/dL beginning after dinner and for 6h thereafter
  • Units of insulin injected beginning after dinner and for 6h thereafter [ Time Frame: 6 hours ]
    Units of insulin injected beginning after dinner and for 6h thereafter
  • Area under the curve when accounting for starting BG beginning after dinner and for 6h thereafter [ Time Frame: 6 hours ]
    Area under the curve when accounting for starting BG beginning after dinner and for 6h thereafter
  • Time in range 70-180 mg/dL beginning of dinner until 12 hours later [ Time Frame: 12 hours ]
    Time in range 70-180 mg/dL beginning of dinner until 12 hours later
  • Number of hypoglycemia events beginning of dinner until 12 hours later [ Time Frame: 12 hours ]
    Number of hypoglycemia events beginning of dinner until 12 hours later
  • Time <70 mg/dL beginning of dinner until 12 hours later [ Time Frame: 12 hours ]
    Time <70 mg/dL beginning of dinner until 12 hours later
  • Time >180 mg/dLbeginning of dinner until 12 hours later [ Time Frame: 12 hours ]
    Time >180 mg/dLbeginning of dinner until 12 hours later
  • Time >250 mg/dLbeginning of dinner until 12 hours later [ Time Frame: 12 hours ]
    Time >250 mg/dLbeginning of dinner until 12 hours later
  • Units of insulin injected beginning of dinner until 12 hours later [ Time Frame: 12 hours ]
    Units of insulin injected beginning of dinner until 12 hours later
  • Area under the curve when accounting for starting BG beginning of dinner until 12 hours later [ Time Frame: 12 hours ]
    Area under the curve when accounting for starting BG beginning of dinner until 12 hours later
  • Time in range 70-180 mg/dL outside of the Study Dinner Sessions [ Time Frame: 2 days ]
    Time in range 70-180 mg/dL outside of the Study Dinner Sessions
  • Number of hypoglycemia events outside of the Study Dinner Sessions [ Time Frame: 2 days ]
    Number of hypoglycemia events outside of the Study Dinner Sessions
  • Time <70 mg/dL outside of the Study Dinner Sessions [ Time Frame: 2 days ]
    Time <70 mg/dL outside of the Study Dinner Sessions
  • Time >180 mg/dL outside of the Study Dinner Sessions [ Time Frame: 2 days ]
    Time >180 mg/dL outside of the Study Dinner Sessions
  • Time >250 mg/dLoutside of the Study Dinner Sessions [ Time Frame: 2 days ]
    Time >250 mg/dLoutside of the Study Dinner Sessions
  • Units of insulin injected outside of the Study Dinner Sessions [ Time Frame: 2 days ]
    Units of insulin injected outside of the Study Dinner Sessions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes
Official Title  ICMJE Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes (Rocket AP)
Brief 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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Device: RocketAP
    Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal
  • Device: USS Virginia
    Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion
Study Arms  ICMJE
  • Experimental: RocketAP
    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.
    Intervention: Device: RocketAP
  • Active Comparator: USS Virginia
    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.
    Intervention: Device: USS Virginia
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. pii: dc210932. doi: 10.2337/dc21-0932. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2021)
19
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2020)
30
Actual Study Completion Date  ICMJE January 21, 2021
Actual Primary Completion Date January 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥12.0 and ≤25 years old at time of consent
  2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
  3. Currently using insulin for at least six months
  4. Currently using insulin pump for at least three months
  5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
  6. Access to internet and willingness to upload data during the study as needed
  7. For females, not currently known to be pregnant or breastfeeding
  8. 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.
  9. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
  10. Willingness to use the UVa artificial pancreas system throughout study sessions.
  11. 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
  12. Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d
  13. 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)
  14. Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission
  15. Willingness to reschedule Study Dinner Sessions if placed on oral steroids
  16. An understanding and willingness to follow the protocol and signed informed consent

Exclusion Criteria:

  1. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
  2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  3. Pregnancy or intent to become pregnant during the trial
  4. Currently being treated for a seizure disorder
  5. Planned surgery during study duration
  6. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
  7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
  8. Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04545567
Other Study ID Numbers  ICMJE 200235
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pending
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Generally will be available after publications completed.
Access Criteria: No restrictions for access.
Responsible Party Mark D. DeBoer, MD, MSc., MCR, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE University of Virginia Launchpad for Diabetes
Investigators  ICMJE
Principal Investigator: Mark D DeBoer, MD, MSc, MCR University of Virginia Center for Diabetes Technology
PRS Account University of Virginia
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP