Recruitment

Recruitment Status
Completed

Inclusion Criterias

HbA1c <10.0%; if HbA1c <6.0% then total daily insulin must be >=0.5 U/kg
Living with 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, and a computer for downloading device data.
...
HbA1c <10.0%; if HbA1c <6.0% then total daily insulin must be >=0.5 U/kg
Living with 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, and a computer for downloading device data.
Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration of each two-week period using the closed-loop system.
Demonstration of proper mental status and cognition for the study.
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.
Age >=18 to <70 years.
Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes
An understanding of and willingness to follow the protocol and sign the informed consent.
Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Awareness score of 2 or lower
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.

Exclusion Criterias

Uncontrolled thyroid disease (TSH undetectable or >10); 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
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist.
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); 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
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist.
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
Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
Abnormal renal function test results (calculated GFR <60); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
Presence of a known adrenal disorder
Admission for diabetic ketoacidosis in the 12 months prior to enrollment.
Active gastroparesis
Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
Severe hypoglycemia resulting in seizure or loss of consciousness 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
Abuse of alcohol or recreational drugs
Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
Cystic fibrosis.

Summary

Conditions
Type 1 Diabetes
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 69 years
Gender
Both males and females

Description

The study phases are as follows: Screening visit to see if you are eligible for the study and to determine how long you will need to use the study CGM (visit 1) Up to 3 weeks using the study CGM (depends on your current CGM use), followed by an office visit (visit 2) 2 weeks using the study insulin ...

The study phases are as follows: Screening visit to see if you are eligible for the study and to determine how long you will need to use the study CGM (visit 1) Up to 3 weeks using the study CGM (depends on your current CGM use), followed by an office visit (visit 2) 2 weeks using the study insulin pump and study CGM together Full day visit in clinic or hotel for training using the system (visit 3) 1 week using the system without automated insulin delivery or suspension 2-day hotel or clinic visit for closed-loop training (visit 4), 16-19 days using the system in the evening and overnight only followed by an office visit (visit 5) 16-19 days using the system for the full 24 hours Final study clinic visit (visit 6) Option 5 month extension phase of day-and-night closed-loop home use

Inclusion Criterias

HbA1c <10.0%; if HbA1c <6.0% then total daily insulin must be >=0.5 U/kg
Living with 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, and a computer for downloading device data.
...
HbA1c <10.0%; if HbA1c <6.0% then total daily insulin must be >=0.5 U/kg
Living with 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, and a computer for downloading device data.
Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration of each two-week period using the closed-loop system.
Demonstration of proper mental status and cognition for the study.
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.
Age >=18 to <70 years.
Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes
An understanding of and willingness to follow the protocol and sign the informed consent.
Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Awareness score of 2 or lower
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.

Exclusion Criterias

Uncontrolled thyroid disease (TSH undetectable or >10); 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
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist.
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); 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
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist.
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
Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
Abnormal renal function test results (calculated GFR <60); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
Presence of a known adrenal disorder
Admission for diabetic ketoacidosis in the 12 months prior to enrollment.
Active gastroparesis
Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
Severe hypoglycemia resulting in seizure or loss of consciousness 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
Abuse of alcohol or recreational drugs
Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
Cystic fibrosis.

Locations

Padova, 93106
Charlottesville, Virginia, 22908
Petah Tikva, 49202
Stanford, California, 94305
Santa Barbara, California, 93105
...
Padova, 93106
Charlottesville, Virginia, 22908
Petah Tikva, 49202
Stanford, California, 94305
Santa Barbara, California, 93105
Montpellier, 34295

Tracking Information

NCT #
NCT02137512
Collaborators
Not Provided
Investigators
  • Principal Investigator: Roy Beck, MD, PhD Jaeb Center for Health Research Study Chair: Boris Kovatchev, PhD University of Virginia
  • Roy Beck, MD, PhD Jaeb Center for Health Research Study Chair: Boris Kovatchev, PhD University of Virginia