USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 30
Inclusion Criteria
- Access to internet and cell phone service at home
- 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.
- 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
- Access to internet and cell phone service at home
- 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.
- 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
Exclusion Criteria
- History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
- Basal Rates <0.01 units/hour.
- 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
- ...
- History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
- Basal Rates <0.01 units/hour.
- 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
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
- Oral steroids
- 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
- 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
- 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.
- Inpatient psychiatric treatment in the past 6 months
- Acetaminophen
- Any other medication that the investigator believes is a contraindication to the subject's participation
- Beta blockers
- Cystic fibrosis
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
- 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
- Presence of a known adrenal disorder
- 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
- Active gastroparesis
- Abuse of alcohol or recreational drugs
- 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
- Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
- 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
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 Criteria
- Access to internet and cell phone service at home
- 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.
- 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
- Access to internet and cell phone service at home
- 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.
- 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
Exclusion Criteria
- History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
- Basal Rates <0.01 units/hour.
- 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
- ...
- History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
- Basal Rates <0.01 units/hour.
- 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
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
- Oral steroids
- 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
- 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
- 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.
- Inpatient psychiatric treatment in the past 6 months
- Acetaminophen
- Any other medication that the investigator believes is a contraindication to the subject's participation
- Beta blockers
- Cystic fibrosis
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
- 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
- Presence of a known adrenal disorder
- 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
- Active gastroparesis
- Abuse of alcohol or recreational drugs
- 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
- Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
- 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
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