Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system. This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas. The insulin and glucagon delivery algorithm is based on the difference between the current blood glucose and the target glucose (proportional error) and the rate of change in blood glucose (derivative error), both adjusted for the recent glucose history. This algorithm is called the Fading Memory Proportional-Derivative (FMPD) Algorithm. The principal investigator of this study has published previous research regarding the use of this algorithm and found it to be well-suited to control blood glucose in type 1 diabetic animals. The addition of glucagon was helpful; better glycemic control with fewer glucose excursions were observed when small intermittent infusions of subcutaneous glucagon were given during times of impending low blood sugar (Ward et al. 2008).

Key facts

Study ID: NCT00797823
Run by: Legacy Health System
People needed: 14
Starts: 2008-11-01
Expected to finish: 2009-09-01
Last updated by the study team: 2011-10-07

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 21-65, history of Type 1 Diabetes Mellitus for > 3 months.
Women:
For women of childbearing potential, a negative urine pregnancy test is required on the first day of the study prior to sensor insertion AND the subject must agree to use contraception prior to and during the study.
For menopausal women or those who have undergone surgical sterilization, no pregnancy test or contraception will be required.
Willingness to attend all clinic visits and participate in two 28-hour studies or one 9-hour study.
Hemoglobin A1C of 5.0-10%. (Values below 5.0 suggest a severe tendency towards hypoglycemia, and values above 10% suggest severely uncontrolled diabetes with risk for ketoacidosis.)
Body mass index of 19-35.

You may not qualify if…

Pregnancy, lactation or refusal to use contraception.
Use of any investigational drug during the 30 days prior to screening.
Enrollment or participation in any other research studies 30 days prior to and during the entirety of sensor insertion.
Current alcohol abuse, substance abuse, or severe mental illness (as judged by the Principal Investigator (PI)).
Any prior cerebrovascular accident or major permanent neurological damage such as aphasia, hemiparesis, or dementia.
A history of cerebrovascular disease or cardiovascular disease regardless of the time since occurrence.
Coronary artery disease (symptomatic or asymptomatic) as manifested by unstable angina, acute coronary syndrome, myocardial infarction or therapeutic coronary procedure (e.g., Percutaneous Transluminal Coronary Angioplasty (PTCA), stent placement, Coronary Artery By-pass Grafting (CABG)) within the prior 6 months.
Any degree of heart failure (as defined by New York Heart Association)..
Renal insufficiency (serum creatinine of > 2.5).
Current foot or leg ulceration.
Peripheral arterial disease with uncontrolled claudication.
Active uncontrolled malignancy except basal cell or squamous cell skin cancers.
Concurrent illness, other than diabetic mellitus, that is not controlled by a stable therapeutic regimen.
Hemoglobin A1C of less than 5.0 or greater than 10%.
A total bilirubin level above 1.5 mg/dl.
Medications: Oral or parenteral corticosteroids (glucocorticoid therapy) are exclusions; topical corticosteroids are not.
Any chronic immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
Visual impairment that would prevent reading the display of the Medtronic Guardian® Receiver.
Physical impairment that would prevent using the buttons of the Medtronic Guardian® Receiver.
Serum Alanine Transaminase (ALT) or Aspartate Transaminase (AST) ≥3x the upper limit of normal.
Serum albumin level of < 3.2 g/dl.
Severe anemia as defined by a hematocrit of < 28%.
Severe serum electrolyte abnormality (sodium, potassium, carbon dioxide, chloride).
Cardiac rhythm disturbance characterized by: 2nd or 3rd degree heart block, bradycardia of less than 50 bpm (exception of bradycardia in an aerobic athlete), tachycardia of greater than 100 bpm, or any arrhythmia judged by the investigator to be exclusionary.
A history of Human Immunodeficiency Virus (HIV) infection.

Where it is running

Legacy Research — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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