N/A
Completed N=11
Closed-loop Glucose Control for Automated Management of Type 1 Diabetes
Source: ClinicalTrials.gov NCT00811317 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Average Blood Glucose Over the Closed-loop Control Period — 164 mg/dl
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Blood Glucose Over the Closed-loop Control Period |
164 | — |
| SECONDARY Percentage of Time Spent Within 70-180 mg/dl |
61 | — |
| SECONDARY Peak Hyperglycemia Following Each Meal |
226.7; 256.7; 276.5 | — |
| SECONDARY Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals |
38 | — |
| SECONDARY Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target) |
6; 0; 0 | — |
| SECONDARY Percentage of Time Spent With BG < 70 mg/dl |
0.35 | — |
| SECONDARY Number of Hypoglycemic Events |
2 | — |
| SECONDARY Nadir Blood Glucose Level for Each Hypoglycemic Event |
66; 68 | — |
| SECONDARY Percentage of Time Spent With BG > 180 mg/dl |
38 | — |
| SECONDARY Total Insulin Dose |
0.67 | — |
| SECONDARY Glucagon T-max |
23 | — |
| SECONDARY Total Glucagon Dose |
3.5 | — |
| SECONDARY Blood Glucagon Levels |
1.7 | — |
| 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 |
— | — |
| SECONDARY Number of Carbohydrate Interventions |
— | — |
| SECONDARY Number of Participants Achieving a Stable Glucose Response to Insulin Dosing |
11 | — |
| SECONDARY Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals |
11 | — |
| SECONDARY Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard |
9.94; 22.55; 18.04 | — |
| SECONDARY Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects |
— | — |
| 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 |
— | — |
| SECONDARY Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard |
18.90; 18.64; 36.46; 20.28; 9.41; 20.71 | — |
| SECONDARY Set Point Using CGM Data as the Input to the Controller for Future Studies |
100 | — |
| 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 |
— | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00811317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.