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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.
Clinical Research Center (CRC) Session Detail (closed-loop control active for all elements)
Day 1 (24+ hours):
Day 2 (24+ hours):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-Loop Control | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control-to-Range Automated Insulin Management System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit | 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%. | Admission Visit 1 |
| Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus | Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range. | 4 hours following the breakfast with a missed meal bolus |
| 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 | Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range. | 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount |
| Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise | Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL. | Following exercise completion |
| Overall frequency of hypoglycemia | Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself. | Includes both admission visits |
| Overall frequency of hyperglycemia | Success defined as no subjects with diabetic ketoacidosis (DKA). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit | 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%. | Admission Visit Day 1 (9:00AM-11:00PM) |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Roy W Beck, MD, PhD | Jaeb Center for Health Research | Study Director |
| Howard Zisser, MD | Sansum Diabetes Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25188375 | Derived | 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. | |
| 25003311 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Includes both admission visits |
| Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit |
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%. |
| Admission Visit Night 1 (11:00PM-8:00AM) |
| Percent of blood glucose values >400 mg/dL during the first admission visit | Individual success is defined as no blood glucose values >400 mg/dL. | Admission Visit 1 |
| Percent of blood glucose values <=60 mg/dL during the first admission visit | No more than 33% of visits with blood glucose <=60 mg/dL | Admission Visit 1 |
| Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus | Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL | 4 hours following the breakfast with a missed meal bolus |
| Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus | Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL | 4 hours following the breakfast with a missed meal bolus |
| 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 | Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL | following the breakfast with a meal bolus 30% more than the recommended bolus amount |
| 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 | Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL | following the breakfast with a meal bolus 30% more than the recommended bolus amount |
| Stanford |
| California |
| 94305 |
| United States |
| University of Colorado Health Sciences Center- Barbara Davis | Aurora | Colorado | 80045 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Montpellier University Hospital | Montpellier | 34295 | France |
| Schneider Children's Medical Center of Israel | Petah Tikva | 49202 | Israel |
| University of Padova | Padova | 93106 | Italy |
| 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |