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