Type 1 Diabetes Clinical Trial
Official title:
Closed-loop Glucose Control for Automated Management of Type 1 Diabetes
Verified date | October 2017 |
Source | Boston University Charles River Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We hypothesize that our integrated closed-loop glucose-control system can provide effective, tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the feasibility of closed-loop BG control.
Status | Completed |
Enrollment | 11 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria (type 1 diabetic subjects): - Age 18 years or older - Clinical type 1 diabetes for at least five years - Otherwise healthy (mild chronic disease allowed if well controlled) - Diabetes managed using an insulin infusion pump - Body mass index (BMI) between 20 and 31 - Total daily dose (TDD) of insulin = 1 U/kg and = 100 U/day - Post-prandial C-peptide < 0.1 nmol/L at 90 minutes in a mixed meal (Sustacal) tolerance test by the DCCT method - Hemoglobin A1c less than or equal to 8.5% - Prescription medication regimen stable for at least 1 month Inclusion Criteria (non-diabetic subjects): - Age 18 years or older - No personal history of diabetes, impaired fasting glucose, or impaired glucose tolerance - No personal history of pancreatic disease - Not taking medication that may affect glucose, insulin, or glucagon dynamics - Otherwise healthy (mild chronic disease allowed if well controlled) - Body mass index (BMI) between 20 and 31 - Normal 75 g oral glucose tolerance test (fasting, 1 hour, and 2 hour measurements) Exclusion Criteria (all subjects): - Unable to provide informed consent or are unable to comply with study procedures - Current participation in another clinical trial - Anemia (HCT or hemoglobin less than normal for sex) - Elevated alanine aminotransferase (ALT > 3 fold above upper limit of normal) - Untreated or inadequately treated hyperthyroidism or hypothyroidism (abnormal TSH or free T4) - Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception - Progressive or proliferative diabetic retinopathy (subjects with mild, non-proliferative background retinopathy or stable disease previously treated with photocoagulation are not excluded). - Renal insufficiency (creatinine clearance estimated by Cockcroft-Gault equation of = 50 ml/min) - Any known history or symptoms of coronary artery disease. - Abnormal EKG - Congestive heart failure - History of TIA or stroke within preceding 6 months - Acute illness or exacerbation of chronic illness at the time of the study procedure - Change in medication regimen in the 30 days prior to enrollment - History of seizures - History of pheochromocytoma - Abnormal plasma fractionated metanephrines - History of adrenal disease or tumor - History of pancreatic tumor, including insulinoma - History of impaired gastric motility or gastroparesis requiring pharmacological or surgical treatment - Current alcohol abuse (> 3 drinks daily) or substance abuse (any use within the last 6 months of illegal drugs) - Severe mental illness (schizophrenia, bipolar disease, inadequately treated depression, or any psychiatric hospitalization in the last year) - Impaired cognition or altered mental status. - Hypertension (blood pressure > 140/90) at the time of screening - Use of medications that reduce gastric motility - Electrically powered implants that might be susceptible to RF interference - Use non-insulin injectable anti-diabetic medications, inhaled insulin, or oral anti-diabetic medications - History of adverse reaction to glucagon (including allergy) besides nausea and vomiting. - Established history of latex, adhesive, tape allergy, inadequate venous access, history of allergy to or intolerance of aspirin. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus | Juvenile Diabetes Research Foundation, Massachusetts General Hospital |
United States,
El-Khatib FH, Jiang J, Damiano ER. A feasibility study of bihormonal closed-loop blood glucose control using dual subcutaneous infusion of insulin and glucagon in ambulatory diabetic swine. J Diabetes Sci Technol. 2009 Jul 1;3(4):789-803. — View Citation
El-Khatib FH, Jiang J, Damiano ER. Adaptive closed-loop control provides blood-glucose regulation using dual subcutaneous insulin and glucagon infusion in diabetic Swine. J Diabetes Sci Technol. 2007 Mar;1(2):181-92. — View Citation
El-Khatib FH, Jiang J, Gerrity RG, Damiano ER. Pharmacodynamics and stability of subcutaneously infused glucagon in a type 1 diabetic Swine model in vivo. Diabetes Technol Ther. 2007 Apr;9(2):135-44. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Blood Glucose Over the Closed-loop Control Period | 24 hours | ||
Secondary | Percentage of Time Spent Within 70-180 mg/dl | 24 hours | ||
Secondary | Peak Hyperglycemia Following Each Meal | After each of 3 meals | ||
Secondary | Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals | After each of 3 meals | ||
Secondary | Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target) | 24 hours | ||
Secondary | Percentage of Time Spent With BG < 70 mg/dl | 24 hours | ||
Secondary | Number of Hypoglycemic Events | This outcome captures the number of hypoglycemic events that occurred throughout the entire study | 24 hours | |
Secondary | Nadir Blood Glucose Level for Each Hypoglycemic Event | 24 hours | ||
Secondary | Percentage of Time Spent With BG > 180 mg/dl | 24 hours | ||
Secondary | Total Insulin Dose | 24 hours | ||
Secondary | Glucagon T-max | Time to maximum peak glucagon concentration | 24 hours | |
Secondary | Total Glucagon Dose | 24 hours | ||
Secondary | Blood Glucagon Levels | 24 hours | ||
Secondary | Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data | 24 hours | ||
Secondary | Number of Carbohydrate Interventions | 24 hours | ||
Secondary | Number of Participants Achieving a Stable Glucose Response to Insulin Dosing | 24 hours | ||
Secondary | Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals | 24 hours | ||
Secondary | Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard | Measuring the mean absolute relative difference (MARD) between the blood glucose measurement and CGM glucose readings, on three different CGM devices: Dexcom, Guardian and Navigator | 24 hours | |
Secondary | Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects | 24 hours | ||
Secondary | Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects | 24 hours | ||
Secondary | Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard | Mean absolute relative difference (MARD) of CGM and BG glucose readings in hypoglycemia (< 70 mg/dl) and hyperglycemia (>180 mg/dl) in three different CGM devices: Dexcom, Navigator and Guardian | 24 hours | |
Secondary | Set Point Using CGM Data as the Input to the Controller for Future Studies | The algorithm in the Bionic Pancreas must have a pre-specified target glucose it is trying to achieve in order to make dosing decisions. Using data from this study, investigators planned to determine what an appropriate glucose target should be for future studies. | 24 hours | |
Secondary | Insulin and Glucagon Levels During Closed Loop and Open Loop Admissions of Diabetic Subjects Compared to the Comparable 24 Hour Period During the Admission of Non-diabetic Subject | 24 hours |
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