At Home Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAs) System and Run-to-Run Adaptation

NCT02705053 | Completed Phase 3 DMC

• 1 other identifier: G150063_2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial is a study to assess the performance of an automated glucose control system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes. Specifically, the investigators will test zone model predictive control AP that will be enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios (CR).

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 1; Artificial Pancreas; Autoimmune Diseases; Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c) (%) from baseline (week 2) to end of week 15 (end of study), with A1c measured at weeks 7 and 11 as well for repeated measures.

  The primary endpoint is change in HbA1c from baseline (end of week 2) to end of week 15 (end of study). HbA1c will be measured at weeks 7 and 11 as well following each adaptation period, so the overall design of the study includes 4 repeated measures and a baseline-end of study contrast.

  13 Weeks

Secondary Outcomes (10)

• Time within the target range for glucose 70-180 mg/dl overall

  1 week

• Time within the tight target range for glucose 80-140 mg/dl overnight

  1 week

• Time within the target range for glucose 70-150 mg/dl postprandial within 5 hours following meals

  1 week

• Markers of hypo- and hyperglycemia

  1 week

• Insulin Doses Given

  1 week

Study Arms (2)

Sensor-Augmented Pump Open-Loop Care (Week 2)

ACTIVE COMPARATOR

The subjects' Sensor-Augmented Pump Open-Loop Care for the second week of the study before any adjustments to pump settings, using a CGM and Insulin Pump.

Device: CGM and Insulin Pump

Closed-Loop Control System with Zone MPC and HMS

EXPERIMENTAL

The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on CGM glucose levels. The Health Monitoring System algorithm uses the same CGM data as the MPC control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values. Using a redundant and independent algorithm is an important safety feature of the overall AP device. Algorithmic adjustment of carbohydrate ratios prior to closed-loop initiation, and continued basal rate and carbohydrate ratio algorithmic optimization during closed-loop use will occur.

Device: Closed-Loop Control System

Interventions

CGM and Insulin Pump DEVICE

Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump.

Sensor-Augmented Pump Open-Loop Care (Week 2)

Closed-Loop Control System DEVICE

The devices that will be used in the Closed-Loop Control System include the following components: DiAs - a smart-phone medical platform; Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)

Closed-Loop Control System with Zone MPC and HMS

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year and an insulin pump for at least 6 months
• Willing to wear the study CGM device for the duration of the study
• Age ≥21 to \<65 years
• HbA1c \<10.0%; if HbA1c \<6.0% then total daily insulin must be ≥0.5 U/kg
• For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
• Demonstration of proper mental status and cognition for the study
• Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes
• Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Unawareness score of 2 or lower
• Access to internet and cell phone service at home, and a computer for downloading device data
• Availability of care partner committed to participating in training activities, knowledgeable at all times of the participant's location, and being available to provide assistance when system is being used at night
• Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration the period using the closed-loop system
• An understanding of and willingness to follow the protocol and sign the informed consent

You may not qualify if:

• Admission for diabetic ketoacidosis in the 12 months prior to enrollment
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
• Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
• History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
• Cystic fibrosis
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
• Presence of a known adrenal disorder
• Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
• Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
• Active gastroparesis
• If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
• Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter or who are on thyroid hormone replacement, and within one year otherwise
• Abuse of alcohol or recreational drugs

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Harvard University: collaborator
• University of California, Santa Barbara: collaborator
• Mayo Clinic: collaborator
• University of Virginia: collaborator
• University of Padova: collaborator

Study Sites (3)

William Sansum Diabetes Center

Santa Barbara, California, 93111, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Dassau E, Pinsker JE, Kudva YC, Brown SA, Gondhalekar R, Dalla Man C, Patek S, Schiavon M, Dadlani V, Dasanayake I, Church MM, Carter RE, Bevier WC, Huyett LM, Hughes J, Anderson S, Lv D, Schertz E, Emory E, McCrady-Spitzer SK, Jean T, Bradley PK, Hinshaw L, Laguna Sanz AJ, Basu A, Kovatchev B, Cobelli C, Doyle FJ 3rd. Twelve-Week 24/7 Ambulatory Artificial Pancreas With Weekly Adaptation of Insulin Delivery Settings: Effect on Hemoglobin A1c and Hypoglycemia. Diabetes Care. 2017 Dec;40(12):1719-1726. doi: 10.2337/dc17-1188. Epub 2017 Oct 13.

  PMID: 29030383 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Autoimmune Diseases; Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Francis J Doyle III, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Eyal Dassau, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Jordan E Pinsker, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

• Ananda Basu, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

• Yogish Kudva, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

• Boris Kovatchev, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Sue Brown, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Stephen Patek, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Claudio Cobelli, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 10, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)