Can Physiologic Insulin Resensitization Therapy Give Patients With Diabetes a Second Chance?

© 2023 HMP Global. All Rights Reserved.
Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Today’s Wound Clinic or HMP Global, their employees, and affiliates.

There are very few times in the life of a patient with a diabetic foot ulcer (DFU), neuropathic ulcer, or even arterial ulcer, when he or she gets a chance to reverse all the damage the disease has done to their body.
 
In my more than 14 years of wound care practice at a hospital base wound care center the only tool I had was hyperbaric oxygen therapy (HBOT). We were able to use this only with a lot of struggles, because the Centers for Medicare and Medicaid Services (CMS) and their policies only allowed us to use it under certain circumstances, and basically when we were at the point of no return despite the well-known benefits of the therapy overall.
 
What would you think if I told you there is something else in the market that can give us and our patients the opportunity of getting all the HBOT benefits plus a whole lot more without exposing them to that thin thread of limb-threatening condition to get “something” done?
 
Physiologic insulin resensitization (PIR) therapy is the not-so-secret weapon. With PIR I’ve achieved same neovascularization and new nerve ending formation that is achieved with HBOT in as low as 8–10 treatments, compared to 16–20 HBOT treatments. Over the last 3 years I haven’t sent any patient for HBOT, and I haven’t had a single amputation with a healing rate of 99.9% within my practice. Keep in mind that like with HBOT, revascularization and adequate local care must be our first and foremost to do in order for any kind of adjuvant therapy to succeed.

What Is Physiologic Insulin Resensitization Therapy?

PIR is a multi-patented treatment modality that provides clinicians with a unique and groundbreaking approach in which insulin is administered dynamically as a hormone rather than a drug. Intravenous access is connected to a precision infusion pump programmed to precisely deliver insulin in a way that simulates normal glucose metabolism. Blood sugar can now more readily enter each cell and be converted into energy. This addresses insulin resistance, which is the primary cause of diabetes, obesity, and other metabolic disorders. Increased cellular energy allows damaged tissues and organs to grow, repair, and regenerate.

Mechanism of Action

• This treatment modality is designed to reduce insulin resistance, which is the primary cause of type 2 diabetes and many other metabolic disorders. 
• With improved insulin sensitivity at the insulin receptor level, glucose can more readily enter cells and be converted into adenosine triphosphate, also known as ATP—a molecule that carries energy within cells. 
• Through increasing cellular energy, PIR is designed to repair and regenerate the body’s cells, peripherally at first. Then, through repeated treatment sessions the cellular restoration progresses to the organ level, which helps the body naturally return to more normal physiologic behavior.
• Thus, the treatment has not only stabilized, but in many instances has reversed complications of diabetes and other metabolic disorders.

Infusion Treatment Modality

• The treatment includes an intravenous precision administration of Food and Drug Administration (FDA)-approved fast-acting insulin using an FDA-approved portable pump.
• The objective of the precise dosing is to achieve biomimicry of insulin as a hormone communicator to stimulate the metabolism—not simply to use insulin as a drug to suppress a high blood sugar, which typically causes insulin resistance at the insulin receptor level.
• The pump's patented biomimicry engineering combined with the treatment modality are designed to administer insulin bio-identically to the body's way of maintaining an optimized metabolism.  
• Along with the insulin hormone, the patient is given small, specific amounts of glucose (ingested as a dextrose liquid) to stimulate the digestive system and its role in the metabolism process during treatment. 

What Conditions Might Benefit From PIR?

Type 1 and type 2 diabetes patients have reported, and their medical professionals have reported to us: reduction in medication usage/dosage, HbA_1c reduction, improvements in cases of diabetic peripheral neuropathy and chronic kidney disease, improved wound healing time, and retinopathy improvements.

A Closer Look at the Evidence for and Risks of PIR

There are several peer-reviewed articles and studies publications in the literature and others are underway to assess patient outcomes in various conditions as noted above.^1–3 Additionally, controlled clinical trials are being designed now with enrollment pending in the United States and abroad.
 
Possible risks: hypoglycemic symptoms, muscle cramps, nausea. Pickle juice, K+ tabs, dextrose 50, and Zofran are stocked in clinic in the event adverse reactions occur.

How Might PIR Be Used for Wound Healing?

Carbohydrate metabolism plays a crucial role in cell growth and proliferation. Glucose, a key component of carbohydrate metabolism, not only provides energy for cells but also supplies the necessary building blocks for synthesizing nucleic acids, proteins, and lipids. In the context of diabetes, proper control of blood glucose levels and metabolism is essential for wound healing. Prolonged hyperglycemia in diabetes can lead to energy deficiency in tissues, resulting in impaired wound healing over time. Hyperglycemia also hampers angiogenesis, the formation of new blood vessels required for tissue repair, by affecting key factors like hypoxia-inducible factor 1-alpha (HIF-1α) and vascular endothelial growth factor (VEGF).
 
Patients with diabetes with poorly controlled glucose levels often experience foot ulcers that heal slowly, get infected, or fail to heal completely. Underlying neuropathy and compromised microcirculation contribute to the development and poor healing of foot ulcers. Optimized glucose ATP production and reduced inflammation, achieved by utilizing glucose as the primary fuel source instead of fat metabolism, can benefit nerve and microvascular tissues in wound healing.

How Can Patients Access This Treatment?

Access is currently limited to physician locations across the country who have exceptional knowledge of insulin resistance and precision dosing of insulin and have licensed access to the FDA cleared infusion devises that give them a better control to precision dose to meet the individual needs of their patients.

What Should the Doctor or Patients Watch out For?

If doctors or patients are interested in pursuing this approach, they should seek out a licensed provider, in good standing with the medical board, that responsibly utilizes this modality to address insulin resistance and metabolic disorders in an adjunct way after other standards of care have failed to adequately address the patient’s health needs. 

The doctor should be objectively measuring their patients’ improvements and adjusting the plan of care dynamically as the patient responds to treatment; typically decreasing in length and frequency over time.

What Questions Should I Ask if I Want to Refer a Patient?

• Does the patient have a medical necessity and have they failed other standards of care?
• Is the practice offering PIR or capable of precision dosing insulin to address hyperinsulinemia and other metabolic disorders while minimizing the known side effects of insulin, i.e., insulin resistance and obesity?

 
This is how small the insulin pump device looks.

Case Studies in Physiologic Insulin Resensitization Therapy

Case 1. A 69-year-old man presented with a right lateral foot ulcer due traumatic shoe injury more than six weeks previous. He had no previous local treatment. His past medical history indicates insulin-dependent diabetes, severe peripheral neuropathy with microvascular disease. He had a femoral-popliteal bypass in 2015. His LDL was 76 and his A_1c was 11.2.
 
The patient started local care with enzymatic debridement and hydrofiber with silver. His first PIR treatment was 4/8/2023, discontinued on 5/30/2023—totaling 8 treatments in 4 weeks. The ulcer healed within four weeks.

Case 2. A 63-year-old man presented with a left plantar neuropathic ulcer of 8 weeks’ duration. His past medical history indicates insulin-dependent diabetes, and a previous below-knee amputation due to gangrene. He had a history of bilateral lower extremity angioplasty 1 year previous, which was patent, with severe microvascular disease and peripheral neuropathy. His A_1c was 8.9 and his LDL was 82.
 
The patient started local care with enzymatic debridement and Hydrofera (Hydrofera), then was lost to follow-up for more than 5 weeks. He returned and immediately started PIR, having his first PIR treatment on 8/11/2022, discontinuing on 9/13/2022 for 11 treatments in 6 weeks. The ulcer healed within six weeks.

Yesenia Justiniano-Rosario, MD, ACHM, FAPWCA, FACCWS, WCC, DMO, is a wound care and hyperbaric specialist at Well Cell Global.

Click here to download a PDF of this article.

References
 
1. Greenway F, Loveridge B, Grimes RM, et al. Physiologic insulin resensitization as a treatment modality for insulin resistance pathophysiology. Int J Mol Sci. 2022 Feb 8;23(3):1884. doi: 10.3390/ijms23031884. PMID: 35163806; PMCID: PMC8836751.

2. Lewis ST, Greenway F, Tucker TR, et al. A receptor story: insulin resistance pathophysiology and physiologic insulin resensitization's role as a treatment modality. Int J Mol Sci. 2023 Jun 30;24(13):10927. doi: 10.3390/ijms241310927. PMID: 37446104; PMCID: PMC10341609.
 
3. Pham RT, Pham-Hoang A, Lewis ST, Greenway F, Dessouki A, Grimes RM. Reversal of diabetic retinopathy in two patients following the use of physiologic insulin resensitization. J Diabetes Complications. 2023 Jun 25;37(9):108549. doi: 10.1016/j.jdiacomp.2023.108549. Epub ahead of print. PMID: 37540985.
 
4. https://wellcellglobal.com/research/