Diabetes mellitus type 1 future or investigational therapies

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Case #1

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Priyamvada Singh, M.B.B.S. [2]; Cafer Zorkun, M.D., Ph.D. [3]Vishal Devarkonda, M.B.B.S[4]

Overview

Future research mainly focuses of artificial pancreas, beta cell replacement, smart insulin, and gene therapy.

Future or Investigational Therapies

Future research or investigational therapies mainly focuses on following areas:

The Artificial Pancreas System (An Autonomous System for Glycemic Control)

Artificial Pancreas

1. Continuous Glucose Monitor (CGM). A CGM provides a steady stream of information that reflects the patient’s blood glucose levels. A sensor placed under the patient's skin (subcutaneously) measures the glucose in the fluid around the cells (interstitial fluid) which is associated with blood glucose levels. A small transmitter sends information to a receiver. A CGM continuously displays both an estimate of blood glucose levels and their direction and rate of change of these estimates.
   • Blood Glucose Device (BGD). Currently, to get the most accurate estimates of blood glucose possible from a CGM, the patient needs to periodically calibrate the CGM using a blood glucose measurement from a BGD; therefore, the BGD still plays a critical role in the proper management of patients with an APDS. However, over time, we anticipate that improved CGM performance may do away with the need for periodic blood glucose checks with a BGD.
2. Control algorithm. A control algorithm is software embedded in an external processor (controller) that receives information from the CGM and performs a series of mathematical calculations. Based on these calculations, the controller sends dosing instructions to the infusion pump. The control algorithm can be run on any number of devices including an insulin pump, computer or cellular phone. The FDA does not require the control algorithm to reside on the insulin pump.
3. Insulin pump. Based on the instructions sent by the controller, an infusion pump adjusts the insulin delivery to the tissue under the skin.
4. The Patient. The patient is an important part of Artificial Pancreas Delivery System. The concentration of glucose circulating in the patient’s blood is constantly changing. It is affected by the patient’s diet, activity level, and how his or her body metabolizes insulin and other substances

Beta cell replacement

• Encapsulated beta cell replacement therapies could liberate people with T1D from the burdens of managing their disease all day, every day.
• Insulin-producing islet cells are wrapped in a protective barrier before implanting them into the body.
• Barrier shields the cells from being destroyed by immune system, but the cells are still able to sense changes in blood-sugar levels and release insulin.
• To watch a video about beta cell replacement and future prospects please click here

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  Beta cell replacement

Glucose-responsive insulin

Glucose-responsive insulin (GRI) or smart insulin would work automatically in response to the body’s level of blood glucose. Turning on when it’s needed to control blood sugar and turning off when blood sugar starts to go low. GRI would help to take the insulin once daily, and then the insulin would handle the rest at a molecular level to maintain control throughout the day.

To watch a video about beta cell replacement and future prospects please click here

Islet Cell Regeneration Approach

Research undertaken at the Massachusetts General Hospital in Boston Masschusetts from 2001 and 2003 demonstrated a protocol to reverse type 1 diabetes in mice. Three other institutions have had similar results, published in the March 24, 2006 issue of Science. A fourth study by the National Institutes of Health further confirmed the approach, and also sheds light on the biological mechanisms involved.

Gene Therapy Approach

Gene therapy: Designing a viral vector to deliberately infect cells with DNA to carry on the viral production of insulin in response to the blood sugar level.

Technology for gene therapy is advancing rapidly such that there are multiple pathways possible to support endocrine function, with potential to practically cure diabetes.

• Gene therapy can be used to manufacture insulin directly: an oral medication, consisting of viral vectors containing the insulin sequence, is digested and delivers its genes to the upper intestines. Those intestinal cells will then behave like any viral infected cell, and will reproduce the insulin protein. The virus can be controlled to infect only the cells which respond to the presence of glucose, such that insulin is produced only in the presence of high glucose levels. Due to the limited numbers of vectors delivered, very few intestinal cells would actually be impacted and would die off naturally in a few days. Therefore by varying the amount of oral medication used, the amount of insulin created by gene therapy can be increased or decreased as needed. As the insulin producing intestinal cells die off, they are boosted by additional oral medications.
• Gene therapy might eventually be used to cure the cause of beta cell destruction, thereby curing the new diabetes patient before the beta cell destruction is complete and irreversible.
• Gene therapy can be used to turn duodenum cells and duodenum adult stem cells into beta cells which produce insulin and amylin naturally. By delivering beta cell DNA to the intestine cells in the duodenum, a few intestine cells will turn into beta cells, and subsequently adult stem cells will develop into beta cells. This makes the supply of beta cells in the duodenum self replenishing, and the beta cells will produce insulin in proportional response to carbohydrates consumed.

Yonsei University study

Scientists in the South Korean university of Yonsei have, in 2000, succeeded in reversing diabetes in mice and rats. Using a viral vector, a DNA encoding the production of an insulin analog was injected to the animals, which remained non-diabetic for at least the eight months duration of the study.

Nanotechnology Approach

Under the nanotechnological approach to curing diabetes type 1, many "nanobots" would be injected into the patient's bloodstream. These nanobots would be able to synthesize insulin, and to secrete it according to the level of glucose they would sense.

Nano Mist

An American body called "Nano Mist" claims to be involved in a diabetes cure-related nanotechnology project. Their product is at least 10 years behind FDA approval.