Type 1 DiabetesCTR3NCT02137512
Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use
A study testing Sensor-Augmented Pump (SAP) in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 6 sites in 4 countries.
Trial summary
The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sensor-Augmented Pump (SAP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Aug 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age >=18 to <70 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
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- Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Awareness score of 2 or lower
- Access to internet and cell phone service at home, and a computer for downloading device data.
- 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.
- 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.
- An understanding of and willingness to follow the protocol and sign the informed consent.
Who cannot join
- 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.
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- 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); 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); 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
- Abuse of alcohol or recreational drugs
- Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
- 7. 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 8. Current use of the following drugs and supplements:
- Acetaminophen
- Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, GLP-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
- Beta blockers
- Oral or injectable glucocorticoids
- Any other medication that the investigator believes is a contraindication to the subject's participation
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
University of Virginia
Charlottesville, Virginia, 22908
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Stanford University
Stanford, California, 94305
Israel1 site
National Center for Childhood Diabetes- Schneider Children's Medical Center
Petah Tikva, 49202
About this study
The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time.
The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not.
At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.
Read the detailed 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 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
- Conditions
- Type 1 Diabetes
- Being tested
- Closed-Loop Control System, Sensor-Augmented Pump (SAP)
- Keywords
- Artificial Pancreas
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-Loop Control SystemDevice
Also called Diabetes Assistant (DiAs)
This investigational device system included the following components:
- DiAs - a smart-phone medical platform;
- Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
- Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
- Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network
- Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
Sensor-Augmented Pump (SAP)Device
This commercial device system included the following components:
- Dexcom G4 Platinum CGM system;
- Roche Accu-Chek insulin pump
| Study group | Role | What they receive |
|---|---|---|
| Closed-Loop Control System | Experimental | Use of an investigational control-to-range automated insulin management (artificial pancreas) system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Receives: Device: Closed-Loop Control System |
| Sensor-Augmented Pump (SAP) | Active comparator | Use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump Receives: Device: Sensor-Augmented Pump (SAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent <70 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00)
Measured: 2 weeks
Secondary outcomes (42)
Time Spent <70 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase
Measured: 2 weeks
Time Spent <70 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Time in Range 70-180 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase
Measured: 2 weeks
Time in Range 70-180 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00)
Measured: 2 weeks
Time in Range 70-180 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Mean Sensor Glucose - Main Phase, Day and Night
Mean CGM sensor glucose during study Main Phase
Measured: 2 weeks
Mean Sensor Glucose - Main Phase, Night Only
Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00)
Measured: 2 weeks
Mean Sensor Glucose - Main Phase, Day Only
Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Glucose Coefficient of Variation - Main Phase, Day and Night
CGM Glucose Coefficient of Variation (CV) during study Main Phase
Measured: 2 weeks
Glucose Coefficient of Variation - Main Phase, Night Only
CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00)
Measured: 2 weeks
Glucose Coefficient of Variation - Main Phase, Day Only
CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Glucose Standard Deviation - Main Phase, Day and Night
CGM Glucose Standard Deviation (SD) during study Main Phase
Measured: 2 weeks
Glucose Standard Deviation - Main Phase, Night Only
CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00)
Measured: 2 weeks
Glucose Standard Deviation - Main Phase, Day Only
CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Time Spent >180 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase
Measured: 2 weeks
Time Spent >180 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, night only (23:00 to 07:00)
Measured: 2 weeks
Time Spent >180 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Time Spent <50 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase
Measured: 2 weeks
Time Spent <50 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, night only (23:00 to 07:00)
Measured: 2 weeks
Time Spent <50 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Time Spent <60 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase
Measured: 2 weeks
Time Spent <60 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, night only (23:00 - 07:00)
Measured: 2 weeks
Time Spent <60 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
LBGI - Main Phase, Day and Night
Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Measured: 2 weeks
LBGI - Main Phase, Night Only
Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Measured: 2 weeks
LBGI - Main Phase, Day Only
Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Measured: 2 weeks
AOC 70 mg/dL - Main Phase, Day and Night
Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Measured: 2 weeks
AOC 70 mg/dL - Main Phase, Night Only
Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Measured: 2 weeks
AOC 70 mg/dL - Main Phase, Day Only
Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Measured: 2 weeks
HBGI - Main Phase, Day and Night
High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Measured: 2 weeks
HBGI - Main Phase, Night Only
High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Measured: 2 weeks
HBGI - Main Phase, Day Only
High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Measured: 2 weeks
ADRR - Main Phase, Day and Night
Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above.
Measured: 2 weeks
AUC 180 mg/dL - Main Phase, Day and Night
Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Measured: 2 weeks
AUC 180 mg/dL - Main Phase, Night Only
Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Measured: 2 weeks
AUC 180 mg/dL - Main Phase, Day Only
Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Measured: 2 weeks
Time Spent >250 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase
Measured: 2 weeks
Time Spent >250 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, night only (23:00 to 07:00)
Measured: 2 weeks
Time Spent >250 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Time Spent >300 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase
Measured: 2 weeks
Time Spent >300 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, night only (23:00 to 07:00)
Measured: 2 weeks
Time Spent >300 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, day only (07:00 - 23:00)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roy Beck, MD, PhD, Principal investigator, Jaeb Center for Health ResearchBoris Kovatchev, PhD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137512
- Sponsor's protocol ID
- Pilot 3 Outpatient CTR
- Acronym
- CTR3
- Status last verified
- Aug 2018
- First submitted
- 12 May 2014
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Anderson SM, Raghinaru D, Pinsker JE, Boscari F, Renard E, Buckingham BA, Nimri R, Doyle FJ 3rd, Brown SA, Keith-Hynes P, Breton MD, Chernavvsky D, Bevier WC, Bradley PK, Bruttomesso D, Del Favero S, Calore R, Cobelli C, Avogaro A, Farret A, Place J, Ly TT, Shanmugham S, Phillip M, Dassau E, Dasanayake IS, Kollman C, Lum JW, Beck RW, Kovatchev B; Control to Range Study Group. Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50. doi: 10.2337/dc15-2468. Epub 2016 Apr 13.
PubMed 27208316
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use
- ClinicalTrials.gov ID
- NCT02137512
- Acronym / sponsor ID
- CTR3 / Pilot 3 Outpatient CTR
- Conditions
- Type 1 Diabetes
- Keywords
- Artificial Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Posted 19 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time.
The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not.
At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.
Detailed 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-Loop Control System | Experimental | Device: Closed-Loop Control SystemUse of an investigational control-to-range automated insulin management (artificial pancreas) system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. |
| Sensor-Augmented Pump (SAP) | Active comparator | Device: Sensor-Augmented Pump (SAP)Use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Age >=18 to <70 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.
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-Loop Control SystemAlso: Diabetes Assistant (DiAs)This investigational device system included the following components: * DiAs - a smart-phone medical platform; * Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; * Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; * Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network * Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class | Device | Closed-Loop Control System |
| Sensor-Augmented Pump (SAP)This commercial device system included the following components: * Dexcom G4 Platinum CGM system; * Roche Accu-Chek insulin pump | Device | Sensor-Augmented Pump (SAP) |
Primary outcome
Time Spent <70 mg/dL - Main Phase, Night Only
Time frame: 2 weeks
Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00)
42 secondary outcomes
Time Spent <70 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
Time Spent <70 mg/dL - Main Phase, Day Only
Time frame: 2 weeks
Time in Range 70-180 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
Time in Range 70-180 mg/dL - Main Phase, Night Only
Time frame: 2 weeks
Time in Range 70-180 mg/dL - Main Phase, Day Only
Time frame: 2 weeks
Mean Sensor Glucose - Main Phase, Day and Night
Time frame: 2 weeks
Mean Sensor Glucose - Main Phase, Night Only
Time frame: 2 weeks
Mean Sensor Glucose - Main Phase, Day Only
Time frame: 2 weeks
Glucose Coefficient of Variation - Main Phase, Day and Night
Time frame: 2 weeks
Glucose Coefficient of Variation - Main Phase, Night Only
Time frame: 2 weeks
Glucose Coefficient of Variation - Main Phase, Day Only
Time frame: 2 weeks
Glucose Standard Deviation - Main Phase, Day and Night
Time frame: 2 weeks
Glucose Standard Deviation - Main Phase, Night Only
Time frame: 2 weeks
Glucose Standard Deviation - Main Phase, Day Only
Time frame: 2 weeks
Time Spent >180 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
Time Spent >180 mg/dL - Main Phase, Night Only
Time frame: 2 weeks
Time Spent >180 mg/dL - Main Phase, Day Only
Time frame: 2 weeks
Time Spent <50 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
Time Spent <50 mg/dL - Main Phase, Night Only
Time frame: 2 weeks
Time Spent <50 mg/dL - Main Phase, Day Only
Time frame: 2 weeks
Time Spent <60 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
Time Spent <60 mg/dL - Main Phase, Night Only
Time frame: 2 weeks
Time Spent <60 mg/dL - Main Phase, Day Only
Time frame: 2 weeks
LBGI - Main Phase, Day and Night
Time frame: 2 weeks
LBGI - Main Phase, Night Only
Time frame: 2 weeks
LBGI - Main Phase, Day Only
Time frame: 2 weeks
AOC 70 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
AOC 70 mg/dL - Main Phase, Night Only
Time frame: 2 weeks
AOC 70 mg/dL - Main Phase, Day Only
Time frame: 2 weeks
HBGI - Main Phase, Day and Night
Time frame: 2 weeks
HBGI - Main Phase, Night Only
Time frame: 2 weeks
HBGI - Main Phase, Day Only
Time frame: 2 weeks
ADRR - Main Phase, Day and Night
Time frame: 2 weeks
AUC 180 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
AUC 180 mg/dL - Main Phase, Night Only
Time frame: 2 weeks
AUC 180 mg/dL - Main Phase, Day Only
Time frame: 2 weeks
Time Spent >250 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
Time Spent >250 mg/dL - Main Phase, Night Only
Time frame: 2 weeks
Time Spent >250 mg/dL - Main Phase, Day Only
Time frame: 2 weeks
Time Spent >300 mg/dL - Main Phase, Day and Night
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27208316Anderson SM, Raghinaru D, Pinsker JE, Boscari F, Renard E, Buckingham BA, Nimri R, Doyle FJ 3rd, Brown SA, Keith-Hynes P, Breton MD, Chernavvsky D, Bevier WC, Bradley PK, Bruttomesso D, Del Favero S, Calore R, Cobelli C, Avogaro A, Farret A, Place J, Ly TT, Shanmugham S, Phillip M, Dassau E, Dasanayake IS, Kollman C, Lum JW, Beck RW, Kovatchev B; Control to Range Study Group. Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50. doi: 10.2337/dc15-2468. Epub 2016 Apr 13.
- Multinational Home Use of Closed-Loop Control Is Safe and EffectiveLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Beck, MD, PhD principal investigator
Jaeb Center for Health Research
Boris Kovatchev, PhD study chair
University of Virginia
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor-Augmented Pump (SAP) in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent <70 mg/dL - Main Phase, Night Only (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.