Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

Type 1 Diabetes Clinical Trial

— CTR  

Official title:

Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271023
• Other study ID #: CTR
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2011
• Last updated: September 7, 2016
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: September 2016
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Clinical Research Center (CRC) Session Detail (closed-loop control active for all elements)

Day 1 (24+ hours):

1. Admission at 7:00 AM

2. Standardized breakfast with normal bolus at 9:00 AM

3. Lunch with normal bolus at 1:00 PM

4. Dinner with normal bolus at 7:00 PM

5. Overnight sleep

6. Breakfast with missed meal bolus followed by user alert and correction bolus

7. Discharge

Day 2 (24+ hours):

1. Admission at 7:00 AM

2. Standardized breakfast with normal bolus at 9:00 AM

3. Lunch with normal bolus at 1:00 PM

4. Exercise

5. Dinner with normal bolus at 7:00 PM

6. Overnight sleep

7. Breakfast with overbolus at 7:00 AM

8. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Control-to-Range Automated Insulin Management System
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.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier
Israel	Schneider Children's Medical Center of Israel	Petah Tikva
Italy	University of Padova	Padova
United States	University of Colorado Health Sciences Center- Barbara Davis	Aurora	Colorado
United States	University of Virginia	Charlottesville	Virginia
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Jaeb Center for Health Research

Countries where clinical trial is conducted

United States,  France,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	Yes
Primary	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	Yes
Primary	Overall frequency of hyperglycemia	Success defined as no subjects with diabetic ketoacidosis (DKA).	Includes both admission visits	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes