Outpatient Control-to-Range: System and Monitoring Testing
Outpatient Control-to-Range: System and Monitoring Testing
Automated closed-loop control (CLC) of blood glucose, known as "artificial pancreas" (AP) can
 have tremendous impact on the health and lives of people with type 1 diabetes (T1DM). The
 investigators inter-institutional and international research team has been on the forefront
 of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006.
 Thus far, the investigators have conducted three closed-loop control clinical trials
 (totaling 60 subjects with T1DM), which demonstrated significantly more time in an acceptable
 "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during
 CLC compared to open loop. The investigators overall objective is to sequentially test,
 validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range
 (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and a
 Hypoglycemia Mitigation Module (HMM). The SSM will monitor the safety of the subject's
 continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia and will also
 monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations
 or loss of sensitivity. The HMM will be responsible for the optimal regulation of
 postprandial hyperglycemic excursions through correction boluses.

 This study will test the ability of AP Platform to (1) run CTR in an outpatient setting, and
 (2) be remotely monitored. Specifically, this study involves studying adults with T1DM who
 are experienced insulin pump users. Subjects will spend two nights (-42 hours) in a local
 hotel, during which the AP Platform will be remotely monitored in an adjacent hotel room for
 validation that remote system monitoring can successfully occur. During the study, study
 subject will be responsible for. operating the CTR system with nursing and technicians
 available
I.A. PURPOSE/OBJECTIVES

 1. Primary objective The purpose of this pilot study is to test a closed-loop
 Control-to-Range (CTR) system in a semi-controlled environment and especially to
 evaluate if the system can accurately collect data coming from patient inputs, insulin
 pump, and continuous glucose monitoring (CGM) device with more than 80% of time of use.

 2. Secondary objectives

 This pilot study will use a Artificial Pancreas Platform (AP Platform) cell phone/phone-based
 system to test an outpatient controller and remote monitoring as follows:

 -  test that the CTR system can be remotely monitored by nurses/physicians/ technicians to
 confirm appropriate functioning outside of the hospital setting

 -  test that the CTR system can be deployed, with appropriate subject response, outside of
 the hospital setting

 I.B. STUDY DESIGN

 This study is an early feasibility pilot trial with the principal goal is to validate an
 initial outpatient ready CTR system and its remote-monitoring capability. Therefore, this is
 an unblinded pilot study and no control group will be used.
Inclusion Criteria:

 1. ≥21 and <65 years old

 2. Clinical diagnosis of type 1 diabetes mellitus:

 Criteria for documented hyperglycemia (at least 1 criterion must be met):

 -  Fasting glucose ≥126 mg/dL - confirmed

 -  Two-hour OGTT glucose ≥200 mg/dL - confirmed

 -  HbA1c ≥6.5% documented by history - confirmed

 -  Random glucose ≥200 mg/dL with symptoms

 -  No data at diagnosis is available but the participant has a convincing history of
 hyperglycemia consistent with diabetes

 Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):

 -  Participant required insulin at diagnosis and continually thereafter

 -  Participant did not start insulin at diagnosis but upon investigator review
 likely needed insulin (significant hyperglycemia that did not respond to oral
 agents) and did require insulin eventually and used continually

 -  Participant did not start insulin at diagnosis but continued to be hyperglycemic,
 had positive islet cell antibodies - consistent with latent autoimmune diabetes
 in adults (LADA) and did require insulin eventually and used continually

 3. Use of an insulin pump to treat his/her diabetes for at least 1 year

 4. Actively using an insulin pump with bolus calculator feature including predefined
 parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active
 insulin.

 5. HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device

 6. Not currently known to be pregnant, breast feeding, or intending to become pregnant
 (females)

 7. Demonstration of proper mental status and cognition for the study

 8. Willingness to avoid consumption of acetaminophen-containing products during the study
 interventions involving DexCom use

 9. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have
 stability on the medication for at least 2 months prior to enrollment in the study

 Exclusion Criteria:

 1. ≥21 and <65 years old

 2. Clinical diagnosis of type 1 diabetes mellitus:

 -  Criteria for documented hyperglycemia (at least 1 criterion must be met):

 -  Fasting glucose ≥126 mg/dL - confirmed

 -  Two-hour OGTT glucose ≥200 mg/dL - confirmed

 -  HbA1c ≥6.5% documented by history - confirmed

 -  Random glucose ≥200 mg/dL with symptoms

 -  No data at diagnosis is available but the participant has a convincing
 history of hyperglycemia consistent with diabetes

 -  Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):

 -  Participant required insulin at diagnosis and continually thereafter

 -  Participant did not start insulin at diagnosis but upon investigator review
 likely needed insulin (significant hyperglycemia that did not respond to
 oral agents) and did require insulin eventually and used continually

 -  Participant did not start insulin at diagnosis but continued to be
 hyperglycemic, had positive islet cell antibodies - consistent with latent
 autoimmune diabetes in adults (LADA) and did require insulin eventually and
 used continually

 3. Use of an insulin pump to treat his/her diabetes for at least 1 year

 4. Actively using an insulin pump with bolus calculator feature including predefined
 parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active
 insulin.

 5. HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device

 6. Not currently known to be pregnant, breast feeding, or intending to become pregnant
 (females)

 7. Demonstration of proper mental status and cognition for the study

 8. Willingness to avoid consumption of acetaminophen-containing products during the study
 interventions involving DexCom use

 9. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have
 stability on the medication for at least 2 months prior to enrollment in the study