Pulsatile insulin

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Pulsatile intravenous insulin therapy, sometimes called metabolic activation therapy or cellular activation therapy, describes in a literal sense the intravenous injection of

hepatic glucose production.[citation needed
]

Background

Dr. Thomas Aoki, former Head of

organ
damage in diabetes is caused by abnormal hepatic glucose metabolism, inadequate insulin delivery, and insulin resistance. He called his approach Metabolic Activation Therapy (MAT), which consisted of an ever-increasing baseline of insulin using Respiratory Quotient to determine the efficiency of treatment (US Patent 4,826,810).

Pulsatile insulin and the liver

Normally, insulin is secreted from the pancreas in pulses into the portal vein which brings blood into the liver in variable amounts, closely related to

gastrointestinal
tract and the pancreas. The insulin retained by the hepatocytes may itself be essential for the long-term effects of insulin on hepatic glucose metabolism as well as growth and de novo enzyme synthesis. Following oral glucose intake, the liver accounts for an equal or greater portion of total net glucose uptake compared to the periphery. Insulin exerts pivotal control of glucose levels through its ability to regulate hepatic glucose production directly or indirectly. The traditional subcutaneous (S.C.) insulin administration regimens used by diabetic patients fails to capture the pulsatile nature of natural insulin secretion and does not reach high enough insulin concentrations at the hepatocyte level (e.g., 10 U regular insulin injected S.C. produce a peak systemic circulation concentration of 30–40 µU/ml and an even lower portal vein concentration of 15–20 µU/ml).

Reviews on efficacy

Several literature reviews by insurers conclude that there is insufficient evidence of efficacy.[1][2][3][4] Studies have not shown a benefit with pulsatile insulin delivery.[5][6]

Third party payment

Most insurers refuse to cover the treatment. In some hearings and cases where a judge has heard evidence, insurance companies have been ordered to pay for that patient. For example, a trial with CalPERS resulted in a decision ordering Blue Cross and other insurance providers to pay for the therapy as to those parties. However, a subsequent assessment by CMS found no evidence that Pulsatile Insulin improves the condition of type 1 and 2 diabetics and has issued a National non-coverage decision which to date is still in effect.[7] CMS has issued a specific code to use when billing this treatment to avoid erroneous payment by billing by the individual procedures that are used in the treatment. Until acceptable clinical trials are performed to show the benefit of pulsatile insulin or Artificial Pancreas Treatment as it is being currently marketed as, the Medicare NCD will continue to remain in effect.

Notes

  1. ^ "Hepatic Activation Therapy". Anthem Blue Cross. Retrieved 6 July 2010.
  2. ^ "Clinical Policy Bulletin: Intermittent Intravenous Insulin Therapy". Aetna. Retrieved 6 July 2010.
  3. ^ "Outpatient Intravenous Insulin Therapy (OIVIT)". Blue Regence. Archived from the original on 19 January 2011. Retrieved 6 July 2010.
  4. ^ "Intermittent Intravenous Insulin Therapy". UnitedHealthcare. Retrieved 28 April 2011.
  5. S2CID 25726389
    .
  6. PMID 12898472
    .
  7. ^ "National Coverage Determination (NCD) for Outpatient Intravenous Insulin Treatment (40.7)". CMS.gov. Retrieved 16 September 2018.
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