- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01271023
Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System (CTR)
The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the insulin.
The study will include two hospital stays consisting of meals and exercise scenarios. Both hospital stays will be for 24+ hours during the day and night. The study will include about 50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical Research Center (CRC) Session Detail (closed-loop control active for all elements)
Day 1 (24+ hours):
- Admission at 7:00 AM
- Standardized breakfast with normal bolus at 9:00 AM
- Lunch with normal bolus at 1:00 PM
- Dinner with normal bolus at 7:00 PM
- Overnight sleep
- Breakfast with missed meal bolus followed by user alert and correction bolus
- Discharge
Day 2 (24+ hours):
- Admission at 7:00 AM
- Standardized breakfast with normal bolus at 9:00 AM
- Lunch with normal bolus at 1:00 PM
- Exercise
- Dinner with normal bolus at 7:00 PM
- Overnight sleep
- Breakfast with overbolus at 7:00 AM
- Discharge
Meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. Between-meal insulin dosing will be fully automated; bolus confirmation by the physician/nurse will be requested by the closed-loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Montpellier University Hospital
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Petah Tikva, Israel, 49202
- Schneider Children's Medical Center of Israel
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Padova, Italy, 93106
- University of Padova
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California
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Santa Barbara, California, United States, 93105
- Sansum Diabetes Research Institute
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Stanford, California, United States, 94305
- Stanford University
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Health Sciences Center- Barbara Davis
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Virginia
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Charlottesville, Virginia, United States, 22908
- University Of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 12 to 65 years
- Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
- For females, not currently known to be pregnant
- Demonstration of proper mental status and cognition for the study
- An understanding of and willingness to follow the protocol and sign the informed consent or assent
Exclusion Criteria:
- Diabetic ketoacidosis in the past 6 months
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- History of a seizure disorder (except hypoglycemic seizure). Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist treatment for a seizure disorder
- Coronary artery disease or heart failure. Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
- Cystic fibrosis
- Active infection
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 or renal function (Transaminase >2 times the upper limit of normal, Creatinine > 1.5 mg/dL)
- 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
- Abuse of alcohol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- 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 exercise protocol
- Current use of a beta blocker medication
- Hematocrit <30% (labs drawn at screening visit or within one month prior to screening for other purposes will suffice for enrollment purposes related to hematocrit)
- Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Closed-Loop Control
The Control to Range algorithm will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.
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The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter.
The Closed-Loop Control System will be used during all 3 admission visits.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit
Time Frame: Admission Visit 1
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Group success criterion defined as a mean blood glucose >50%, lower end of one-sided 95% confidence interval >40% and individual criterion of no individual <30%.
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Admission Visit 1
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Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus
Time Frame: 4 hours following the breakfast with a missed meal bolus
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Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range.
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4 hours following the breakfast with a missed meal bolus
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Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
Time Frame: 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
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Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range.
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5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
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Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise
Time Frame: Following exercise completion
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Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.
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Following exercise completion
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Overall frequency of hypoglycemia
Time Frame: Includes both admission visits
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Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.
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Includes both admission visits
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Overall frequency of hyperglycemia
Time Frame: Includes both admission visits
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Success defined as no subjects with diabetic ketoacidosis (DKA).
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Includes both admission visits
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit
Time Frame: Admission Visit Day 1 (9:00AM-11:00PM)
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Group success criterion defined as a mean blood glucose >50%, lower end of one-sided 95% confidence interval >40% and individual criterion of no individual <30%.
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Admission Visit Day 1 (9:00AM-11:00PM)
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Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit
Time Frame: Admission Visit Night 1 (11:00PM-8:00AM)
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Group success criterian defined as a mean blood glucose >60%, lower end of one-sided 95% confidence interval >50% and individual criterion of no individual <30%.
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Admission Visit Night 1 (11:00PM-8:00AM)
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Percent of blood glucose values >400 mg/dL during the first admission visit
Time Frame: Admission Visit 1
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Individual success is defined as no blood glucose values >400 mg/dL.
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Admission Visit 1
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Percent of blood glucose values <=60 mg/dL during the first admission visit
Time Frame: Admission Visit 1
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No more than 33% of visits with blood glucose <=60 mg/dL
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Admission Visit 1
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Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus
Time Frame: 4 hours following the breakfast with a missed meal bolus
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Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
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4 hours following the breakfast with a missed meal bolus
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Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus
Time Frame: 4 hours following the breakfast with a missed meal bolus
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Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL
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4 hours following the breakfast with a missed meal bolus
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Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Time Frame: following the breakfast with a meal bolus 30% more than the recommended bolus amount
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Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
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following the breakfast with a meal bolus 30% more than the recommended bolus amount
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Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Time Frame: following the breakfast with a meal bolus 30% more than the recommended bolus amount
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Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL
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following the breakfast with a meal bolus 30% more than the recommended bolus amount
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Roy W Beck, MD, PhD, Jaeb Center for Health Research
- Study Chair: Howard Zisser, MD, Sansum Diabetes Research Institute
Publications and helpful links
General Publications
- Chase HP, Doyle FJ 3rd, Zisser H, Renard E, Nimri R, Cobelli C, Buckingham BA, Maahs DM, Anderson S, Magni L, Lum J, Calhoun P, Kollman C, Beck RW; Control to Range Study Group. Multicenter closed-loop/hybrid meal bolus insulin delivery with type 1 diabetes. Diabetes Technol Ther. 2014 Oct;16(10):623-32. doi: 10.1089/dia.2014.0050. Epub 2014 Sep 4.
- Zisser H, Renard E, Kovatchev B, Cobelli C, Avogaro A, Nimri R, Magni L, Buckingham BA, Chase HP, Doyle FJ 3rd, Lum J, Calhoun P, Kollman C, Dassau E, Farret A, Place J, Breton M, Anderson SM, Dalla Man C, Del Favero S, Bruttomesso D, Filippi A, Scotton R, Phillip M, Atlas E, Muller I, Miller S, Toffanin C, Raimondo DM, De Nicolao G, Beck RW; Control to Range Study Group. Multicenter closed-loop insulin delivery study points to challenges for keeping blood glucose in a safe range by a control algorithm in adults and adolescents with type 1 diabetes from various sites. Diabetes Technol Ther. 2014 Oct;16(10):613-22. doi: 10.1089/dia.2014.0066. Epub 2014 Jul 8. Erratum In: Diabetes Technol Ther. 2015 Jan;17(1):68. Vistenin, Roberto [corrected to Visentin, Roberto].
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTR
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