Recruiting
Phase 3

Insulin Delivery

Sponsor:

Global Infusion and Aspiration Systems, LLC

Code:

NCT01023165

Conditions

Diabetes Mellitus

Metabolic Integrity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Humulin, Humalog, Novolog

Study Details

Brief summary:

The purpose of this study is to determine if restoring normal metabolic function in patients with type 1 or type 2 diabetes can improve the impact of the consequences of diabetic complications on the overall health and quality of life for diabetic patients.Patients are treated once per week with intensive bolus intravenous insulin delivery mimicking normal insulin secretions in a non diabetic individual. Baseline and periodic diagnostic tests are performed and questionnaires completed to evaluate and monitor progress and outcomes.

Conditions

Diabetes Mellitus

Metabolic Integrity

Study ID

NCT01023165

Start date

Nov, 2009

Status verified date

Jun, 2011

Completion date

Nov, 2015

Anticipated

Primary completion date

Nov, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed with significant complications resulting from diabetes
  • Ability to swallow without difficulty
  • Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time Supervising physician must evaluate and diagnose one of the following medical conditions to be eligible to participate in study
  • Hypoglycemia unawareness
  • Significant proteinuria (>300 mg/24 hrs) in spite of ACE inhibitors and/or ARB's.
  • Diabetic nephropathy
  • Progressive, significant diabetic peripheral neuropathy.
  • Orthostatic hypotension due to autonomic neuropathy of advanced diabetes.
  • Advanced gut neuropathy with gastroparesis or diabetic diarrhea.
  • Non-healing diabetic wounds
  • Diabetic retinopathy

Exclusion Criteria:

  • Lack of intravenous access
  • Inability to breathe into a respiratory quotient machine
  • Subjects on dialysis
  • Presence of severe underlying chronic disease (e.g. coronary artery disease, hepatic disease) which in the opinion of the investigator is likely to preclude the subject from completing the full term of the study
  • Inability to stabilize blood pressure at 140/90 or below using ACE inhibitors, Ca channel blockers, Alpha 1 blockers, central Alpha2 agonists or diuretics
  • Pregnancy or contemplated pregnancy
  • Alcohol abuse, drug addiction or the use of illegal drugs
  • Active liver disease
  • Active chemotherapy
  • Positive HIV
  • Subjects with a history of poor compliance to drug or diet or placebo therapy or keeping appointments

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IV bolus insulin, metabolic integrity

Diabetic patients will complete diagnostic testing and complete quality of life questionnaires at baseline and every six months thereafter while enrolled in the study to monitor and assess progress with metabolic integrity and complications resulting from their diabetes. Comparisons will be performed on lab values performed at baseline and every six months thereafter. Supervising physician may request testing be performed more frequently as deemed medically necessary, testing may include retinal photography, nerve conduction and labs. Meds and medical intervention information is collected weekly at the Intravenous Bolus Insulin treatment sessions. An annual evaluation is performed to review clinical data collected and evaluate progress for analysis and comparison.

Interventions

Humulin, Humalog, Novolog

Supervising Physician reviews patient activation after intravenous bolus insulin treatment each week and adjusts the amounts of insulin and carbohydrates to be given in the next treatment session based on patient treatment outcomes.

Primary outcome measure

  • Researchers will assess whether restoring metabolic integrity to diabetic patients improves quality of life and complications associated with diabetes [ Time Frame: Patients will have diagnostic testing and complete questionnaires at baseline and every six months thereafter or more frequently if the supervising physician deems medically appropriate throughout the study to monitor and evaluate progress. ]

Central Contacts and Locations

Central contacts

Michael Cockrell, MD

662-267-2025lg@global-infusions.com

Lee Garner, BA

662-267-2025lg@globalinfusions.com

Locations

Global Infusion and Aspiration Systems, LLC

Recruiting

Batesville, Mississippi, United States, 38606

Contacts

Lee Garner, BA

662-267-2025lg@global-infusions.com

Principal Investigator:

Michael Cockrell, MD

More Information

Sponsor

Global Infusion and Aspiration Systems, LLC

Last update posted

Jun 22, 2011

Last verified

Jun, 2011

Keywords

  • Diabetes Mellitus
  • Metabolic Integrity
  • Intravenous Bolus Insulin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Global Infusion and Aspiration Systems, LLC on 2011-06-22.