NCT01029639

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

August 6, 2009

Last Update Submit

August 8, 2016

Conditions

Hypoglycemia

Keywords

Pulsatile intravenous insulinOral carbohydrate loadingRespiratory QuotientsHypoglycemiaDiabetes Mellitus, with complications

Outcome Measures

Primary Outcomes (1)

  • 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.

    Every 3 months

Study Arms (2)

Treatment

NO INTERVENTION

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.

Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)

EXPERIMENTAL

Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session

Procedure: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)

Interventions

Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)PROCEDURE

Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session

Also known as: Humulin R, Novolog
Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University Center for Complex Systems and Brain Sciences

Boca Raton, Florida, 33431, United States

Location

Related Publications (1)

  • Quinones MJ, Nicholas SB, Lyon CJ. Insulin resistance and the endothelium. Curr Diab Rep. 2005 Aug;5(4):246-53. doi: 10.1007/s11892-005-0018-z.

    PMID: 16033673BACKGROUND

MeSH Terms

Conditions

HypoglycemiaDiabetes Complications

Interventions

InsulinInsulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

Study Officials

  • Betty Tuller, PhD

    Florida Atlanctic University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2009

First Posted

December 10, 2009

Study Start

January 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

US(1)