N/A
Completed N=12
Inpatient Closed-loop Glucose Control
Source: ClinicalTrials.gov NCT01819844 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. — 115.9; 107.0; 124.83 mg/dl
Summary
The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. |
115.9; 107.0; 124.83 | — |
| SECONDARY Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol |
— | — |
| SECONDARY Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements |
4 | — |
| SECONDARY Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl |
95.5; 67.5; 0.25; 4.3 | — |
| SECONDARY Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm |
115.8 | — |
| SECONDARY Number of BG Events < 70 mg/dl as Determined by the CGM |
8 | — |
| SECONDARY Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl |
1.5; 66.8; 94.4; 4.0 | — |
| SECONDARY Insulin Dosing (u/kg) |
0.42 | — |
| SECONDARY Dextrose Dosing (g/kg) |
0.48 | — |
| SECONDARY Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard. |
8.29 | — |
Eligibility Criteria
Inclusion Criteria
Subjects with type 1 diabetes
- Age 21 to 75 with clinical type 1 diabetes for at least one year
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
- Total daily dose (TDD) of insulin that is 1 u/kg/day but 2 u/kg/day
Exclusion Criteria
- Pregnancy
- Renal insufficiency
- Cancer
- Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
- Acute illness or exacerbation of chronic illness at the time of the study procedure
- Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin
- History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders
- Known history of coronary artery disease, TIA or stroke
- History of seizures
- Transaminitis
- Stage 2 hypertension at the time of screening
Data sourced from ClinicalTrials.gov (NCT01819844). 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.