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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
14 participants (actual)
Sponsor
Legacy Health System · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
Nov 2008
Primary completion
Sept 2009
Completion
Sept 2009
First posted
25 Nov 2008 (estimated)
Last update posted
7 Oct 2011 (estimated)
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010
  1. Ph 2

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

    NCT00797823

    Nov 2008 to Sept 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Insulin, Asp(B28)-Drug
  • GlucagonDrug
  • PlaceboDrug

Arms3

  • Placebo comparator

    Insulin + Placebo

    Glycemic control of subject participants was managed by the closed-loop system which delivered insulin and normal saline (instead of glucagon) as a placebo, based upon algorithm calculations.

  • Active comparator

    Insulin + Glucagon

    Glycemic control of subject participants was managed by the system which delivered insulin and glucagon based upon algorithm calculations.

  • Experimental

    Pilot Study

    Pilot studies designed to assess safety of the system. Includes 6 participants undergoing 7 studies.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Effectiveness of Closed Loop Diabetes Control

    Time frame · 1 year

    Registry description

    Effectiveness of closed loop diabetes control will be measured by mean glucose.

Secondary outcomes(1)
  1. Percent of Time Venous Blood Glucose <70 mg/dl

    Time frame · 1 year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 1 year

Effectiveness of Closed Loop Diabetes Control

GroupValue (mg/dl)Spread
Placebo Comparator: Insulin Alone136.95.0
Active Comparator: Insulin Plus Glucagon149.55.5
Secondary and other outcome results(1)
Secondary outcomeMean· 1 year

Percent of Time Venous Blood Glucose <70 mg/dl

GroupValue (percent of time)Spread
Placebo Comparator: Insulin Alone2.80.67
Active Comparator: Insulin Plus Glucagon1.150.41

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Insulin + Glucagon -> Insulin + Placebo)This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).–0 / 44 / 4
Insulin + Placebo -> Insulin + GlucagonThis group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).–0 / 44 / 4
PilotPilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.–0 / 61 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * An active hepatitis infection. * Known allergy to any type of insulin * Insulin resistance requiring more than 200 units of insulin per day * Known bleeding disorders or chronic usage of warfarin. * Any known seizure disorder. * Past history of pheochromocytoma or a family history of Multiple Endocrine Neoplasia (MEN) 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease. * Hypoglycemic unawareness or chronic hypoglycemia. * A severe hypoglycemic event which required hospitalization within the past two years. * Adrenal insufficiency. * Insulinoma. * Use of both acetaminophen and ascorbic acid. * Impaired mentation or psychiatric diagnoses * Uncontrolled candidiasis. * Any known allergy to glucagon.

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