Effects of Pulsatile Intravenous Insulin Delivery on Hypoglycemic Unawareness

This study has been terminated.
(Administrative)
Sponsor:
Collaborators:
Advanced Diabetes Treatment Centers
Global Infusions
Information provided by:
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT01029639
First received: August 6, 2009
Last updated: December 9, 2009
Last verified: August 2009
  Purpose

Hypoglycemic unawareness is a major problem in the treatment of Diabetes Mellitus. Hypoglycemic unawareness is the inability to recognize or sense early symptoms of low blood sugar. This study was instituted to evaluate the effect of Pulsatile intravenous (IV) Insulin on improving or reinstating the diabetics ability to sense or feel the symptoms associated with low blood sugar.


Condition Intervention Phase
Hypoglycemia
Procedure: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Pulsatile Intravenous Insulin Delivery on Hypoglycemic Unawareness

Resource links provided by NLM:


Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:
  • Questionnaires completed by subjects at baseline quarterly to assess ability to sense low blood sugar. Tracking incidences requiring outside assistance including paramedics, ER visits and hospitalizations due to low blood sugar incidences. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
Diabetic patients will complete hypoglycemia unawareness questionnaires at baseline and quarterly thereafter to monitor and assess progress with complications resulting from their diabetes. Comparisons will be performed on low blood sugar incidences reported by subjects requiring heath care intervention other than by the subject themselves.
Procedure: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)
Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session
Other Name: Humulin R, Novolog

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Up to 400 patients both male and female between the ages of 20 and 90 diagnosed with type 1 or type 2 diabetes mellitus.
  • All patients were diagnosed by their endocrinologists as having hypoglycemic unawareness, inability to sense low blood sugars.
  • All patients had failed conventional treatment for hypoglycemic unawareness.
  • All patients are taking oral agents and/or insulin for diabetic control.
  • All patients are under an endocrinologist's supervision for their diabetes management.
  • Endocrinologist must assess and approve patient for participation in this study.
  • All patients must demonstrate the ability to swallow without difficulty and the ability to commit to the weekly time requirements associated with the study.

Exclusion Criteria:

  • Other causes of complications not related to diabetes.
  • Lack of intravenous access.
  • Pregnancy.
  • Alcohol abuse, drug addiction or the use of illegal drugs.
  • HIV positive.
  • Inability to breathe into machine for respiratory quotients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029639

Locations
United States, Florida
Florida Atlantic University Center for Complex Systems and Brain Sciences
Boca Raton, Florida, United States, 33431
Sponsors and Collaborators
Florida Atlantic University
Advanced Diabetes Treatment Centers
Global Infusions
Investigators
Principal Investigator: Betty Tuller, PhD Florida Atlanctic University
  More Information

Publications:
Responsible Party: Betty Tuller PhD Professor of Complex Systems and Brain Sciences, Florida Atlantic University
ClinicalTrials.gov Identifier: NCT01029639     History of Changes
Other Study ID Numbers: H08-248, MH42900 and MH01386
Study First Received: August 6, 2009
Last Updated: December 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Atlantic University:
Pulsatile intravenous insulin
Oral carbohydrate loading
Respiratory Quotients
Hypoglycemia
Diabetes Mellitus, with complications

Additional relevant MeSH terms:
Hypoglycemia
Unconsciousness
Glucose Metabolism Disorders
Metabolic Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Insulin Aspart
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014