N/A
Completed N=24
Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas
Source: ClinicalTrials.gov NCT01161862 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl) — 132; 146; 162; 175 mg/dl
Summary
The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl) |
132; 146; 162; 175 | — |
| SECONDARY Percentage of Time Spent With Blood Glucose < 60 mg/dl |
2.3; 1.4; 0.1; 0.1 | — |
| SECONDARY Percentage of Time Spent With Blood Glucose <70 mg/dl |
5.1; 3.6; 0.3; 0.4 | — |
| SECONDARY Percentage of Time Spent With Blood Glucose 70-180 mg/dl |
80; 70; 68; 60 | — |
| SECONDARY Insulin Total Daily Dose |
0.6; 0.7; 1.1; 1.2 | — |
| SECONDARY Number of Carbohydrate Interventions for Hypoglycemia |
12; 10 | — |
| SECONDARY Number of Blood Glucose Events < 70 mg/dl |
59; 48 | — |
| SECONDARY Nadir Blood Glucose in Each Arm |
65.9; 66.4 | — |
Eligibility Criteria
Inclusion Criteria
- Age 12 years or older with clinical type 1 diabetes for at least one year
- Weight > 41 kg
- Otherwise healthy (mild chronic disease allowed if well controlled)
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
- Body mass index (BMI) between 20 and 35 for subjects >18 years of age or BMI between the 5th and 95th percentile for age for subjects 18 years of age or unable to provide assent if 3 fold above upper limit of normal
- Untreated or inadequately treated hyperthyroidism or hypothyroidism
- Pregnancy
- Renal insufficiency (creatinine clearance ≤ 50 ml/min)
- Any known history of coronary artery disease
- Abnormal EKG including, but not limited to evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), arrhythmia, tachycardia, and prolonged QT interval (> 440 ms)
- Congestive heart failure
- History of TIA or stroke
- Acute illness or exacerbation of chronic illness
- History of seizures
- History of pheochromocytoma (fractionated metanephrines will be tested in patients with history suggestive of pheochromocytoma)
- 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 (intake averaging > 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription)
- Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year)
- Impaired cognition or altered mental status.
- Hypertension (blood pressure > 140/90 or > 95% for age, height and weight in subjects < 18 years of age) at the time of screening
- Use of medications that reduce gastric motility (e.g. narcotics, anti-spasmodics, anticholinergics).
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
- Use non-insulin, injectable anti-diabetic medications
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Established history of latex, adhesive, or tape allergy
- Inadequate venous access
- History of allergy to aspirin or any history of aspirin intolerance, including Reye syndrome, or gastric ulcer or bleeding associated with salicylates
- Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrands disorder, and idiopathic thrombocytopenic purpura (ITP)
- Peptic ulcer
- Unable to perform 30 minutes of moderate exercise on a treadmill or exercise bicycle
- Unable or unwilling to discontinue dietary supplements for at least 2 weeks prior to each CRC admission
- History of celiac disease
Data sourced from ClinicalTrials.gov (NCT01161862). 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.