Recruitment

Recruitment Status
Completed
Estimated Enrollment
30

Inclusion Criterias

Access to internet and cell phone service at home
Availability of a significant other or family member committed to participating in all training activities, knowledgeable at all times of the participant's location, and being present and 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 of the period of time using the closed-loop system at home.
Access to internet and cell phone service at home
Availability of a significant other or family member committed to participating in all training activities, knowledgeable at all times of the participant's location, and being present and 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 of the period of time using the closed-loop system at home.

Exclusion Criterias

Basal Rates <0.01 units/hour.
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
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
...
Basal Rates <0.01 units/hour.
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
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
Oral steroids
Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months.
Presence of a known adrenal disorder
Any other medication that the investigator believes is a contraindication to the subject's participation
Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
Beta blockers
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
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
Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
Abuse of alcohol or recreational drugs
Inpatient psychiatric treatment in the past 6 months
Acetaminophen
Active gastroparesis
Cystic fibrosis
Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, glucagon-like peptide (GLP)-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
Admission for diabetic ketoacidosis in the 12 months prior to enrollment
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

Summary

Conditions
Diabetes Mellitus
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 65 years
Gender
Both males and females

Description

The subject will participate in both the Experimental and the Control Admissions. The order of the two admissions will be randomized. During the Control Admission at home, the subject will use the study insulin pump along with a continuous glucose monitor receiver. During the Experimental Admission,...

The subject will participate in both the Experimental and the Control Admissions. The order of the two admissions will be randomized. During the Control Admission at home, the subject will use the study insulin pump along with a continuous glucose monitor receiver. During the Experimental Admission, the subject will be the research house/hotel where the subject will be in control of the DiAs. Participation in this study will require 5 study visits over 11-14 weeks.

Inclusion Criterias

Access to internet and cell phone service at home
Availability of a significant other or family member committed to participating in all training activities, knowledgeable at all times of the participant's location, and being present and 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 of the period of time using the closed-loop system at home.
Access to internet and cell phone service at home
Availability of a significant other or family member committed to participating in all training activities, knowledgeable at all times of the participant's location, and being present and 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 of the period of time using the closed-loop system at home.

Exclusion Criterias

Basal Rates <0.01 units/hour.
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
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
...
Basal Rates <0.01 units/hour.
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
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
Oral steroids
Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months.
Presence of a known adrenal disorder
Any other medication that the investigator believes is a contraindication to the subject's participation
Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
Beta blockers
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
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
Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
Abuse of alcohol or recreational drugs
Inpatient psychiatric treatment in the past 6 months
Acetaminophen
Active gastroparesis
Cystic fibrosis
Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, glucagon-like peptide (GLP)-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
Admission for diabetic ketoacidosis in the 12 months prior to enrollment
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

Locations

Padova, 35131
Rochester, Minnesota, 55905
New York, New York, 10029-6574
Charlottesville, Virginia, 22903
...
Padova, 35131
Rochester, Minnesota, 55905
New York, New York, 10029-6574
Charlottesville, Virginia, 22903

Tracking Information

NCT #
NCT02131766
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
  • Principal Investigator: Sue Brown, MD University of Virginia Principal Investigator: Carol Levy, MD, CDE MOUNT SINAI HOSPITAL Principal Investigator: Yogish C. Kudva, MBBS, MD Mayo Clinic Principal Investigator: Claudio Cobelli, PhD University of Padova
  • Sue Brown, MD University of Virginia Principal Investigator: Carol Levy, MD, CDE MOUNT SINAI HOSPITAL Principal Investigator: Yogish C. Kudva, MBBS, MD Mayo Clinic Principal Investigator: Claudio Cobelli, PhD University of Padova