N/A
Completed N=12
Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)
Source: ClinicalTrials.gov NCT00977808 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Occurrence of Hypoglycemic Episodes — 5; 23 Hypoglycemic Episodes
Summary
This study plans to link two existing technologies, the insulin pump and the continuous glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop. This will be done using two continuous glucose monitors (CGMs), a computer containing an investigational control algorithm that uses glucose information from the CGM to recommend insulin dosing, and an insulin pump. The purpose of this study is to test the ability of continuous glucose monitors together with an insulin pump and a mathematical formula to control blood sugar levels of people with type 1 diabetes.
The Closed-Loop control algorithm will:
1. Suggest adequate insulin delivery for blood glucose control in steady state (overnight);
2. Cover adequately with an insulin bolus the pre-set carbohydrate content of a breakfast.
If successful, this study will conceptually prove the feasibility of automated model-predictive closed-loop glucose control in T1DM.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Hypoglycemic Episodes |
5; 23 | — |
Eligibility Criteria
Inclusion Criteria
- 21 years of age or older
- Have Type 1 Diabetes Mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 2 years (including those who may also be treated with metformin, thiazolidinedione, exenatide, or pramlintide).
- Use of an insulin pump
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 1 month prior to enrollment in the study
- Willingness to use lispro (Humalog) insulin for the duration of the inpatient study
- Demonstration of proper mental status and cognition for the study
Exclusion Criteria
- Age 50%).
- Congestive heart failure
- History of a cerebrovascular event
- Use of a medication that significantly impacts glucose metabolism (oral steroids)
- Atrial fibrillation
- Uncontrolled hypertension (resting blood pressure >140/90)
- History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
- Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the FreeStyle NavigatorTM CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
- Active enrollment in another clinical trial
- Allergy or adverse reaction to lispro insulin
- Known adrenal gland problem, pancreatic tumor, or insulinoma
- Current alcohol abuse, substance abuse, or severe mental illness
- Retinopathy and renal failure
- Uncontrolled anxiety or panic disorder
- Known bleeding diathesis or dyscrasia
- Renal insufficiency (creatinine >1.5)
- Any comorbid condition affecting glucose metabolism
Data sourced from ClinicalTrials.gov (NCT00977808). 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.