Advances in Type 1 Diabetes Research and Treatment
Review the latest cutting-edge advances in type 1 diabetes including an oral anti-diabetes agent, the artificial pancreas, and precision medicine updates.
What is Diabetes?
Characterized by high blood sugar levels (hyperglycemia), there are two major forms of diabetes: Type 1 and Type 2. Type 2 diabetes (T2D) is by far the most common, affecting over 30 million Americans. Type 1 diabetes (T1D) affects only 1.25 million Americans, making up less than 5% of cases.
Diabetes is an increasingly common disease, now diagnosed in over 9% of the US population.
For all diabetics, tight blood glucose control is essential to prevent or delay diabetic complications including cardiovascular disease, neuropathy, nephropathy, and retinopathy.
Differences between Type 1 and Type 2
While Type 1 and Type 2 diabetes share the same name and can lead to the same complications, the causes and treatment for each are quite different.
Type 1 Diabetes
T1D is an autoimmune disease in which the body’s immune system mistakes insulin-producing beta cells as foreign and destroys them. Type 1 diabetics eventually stop producing insulin and must therefore take insulin to manage blood sugar levels.
T1D is irreversible and has no cure.
Type 2 Diabetes
T2D is a metabolic disorder. The body still produces insulin but can’t use it effectively. This is known as insulin resistance. Patients with T2D are encouraged to manage the disease with diet, exercise, and/or oral medication, though insulin can be used if lifestyle changes and treatment don’t work.
Advances in Type 1 Diabetes Treatment
Oral Type 1 Diabetes Treatment
There is a lot of excitement in the T1D drug development community over Zynquista™ (sotagliflozin), which could be the first oral antidiabetes medication for T1D patients to hit the market. Sotagliflozin is developed by Lexicon Pharmaceuticals, in partnership with Sanofi, who had their NDA accepted by the FDA in May this year. The target action date by the FDA for the drug is March 2019.
Sotagliflozin inhibits SGLT-1 and SGLT-2 (sodium-glucose cotransporter types 1 and 2), which are the transporters responsible for glucose reabsorption. This SGLT-1 and SGLT-2 inhibition lowers blood glucose levels by increasing glucose excretion in urine. The drug has been shown to improve glucose control in adult type 1 diabetics. As well as lowering A1c levels without increasing hypoglycemia, sotagliflozin also reduced patients’ body weight, blood pressure, and time within range.
The medication is taken once daily alongside insulin.
Artificial Pancreas for Type 1 Diabetics
Insulin pumps are becoming increasingly common as an alternative to insulin injections for T1D blood sugar management. Resembling pagers, they infuse insulin throughout the day via a catheter placed under the skin. The patient can administer larger doses (boluses) of insulin as needed, for meals or to correct high blood sugar levels.
Traditionally, T1D patients test their blood sugar levels multiple times a day via finger stick. A newer, wearable technology called continuous glucose monitoring (CGM), is an alternate method to monitor blood sugar levels constantly, in real time. Finger sticks are still required to calibrate the device, but blood glucose is measured every few minutes by a small sensor with a transmitter, that then sends BG readings to a receiver or smart phone.
For years, T1D patients have been waiting for a closed loop system or “artificial pancreas” to become available – essentially allowing the CGM and insulin pump to communicate and adjust doses based on an algorithm rather than needing user input.
FDA Approved Artificial Pancreas
In September 2016, the FDA approved Medtronic’s MiniMed 670G hybrid closed looped system, which is the first device considered an “artificial pancreas”. The system uses a CGM, an insulin pump, and a control system to automatically manage blood sugar levels.
The system has been on the market for over a year, and Medtronic presented excellent results from the accumulated patient data at this year’s ADA Conference. From over 32,000 patients, the average time in range was 70%, close to the 73% observed in clinical trials.
The device was initially approved from Type 1 diabetics over 14 years old, but in June this year the FDA expanded approval to cover 7-13 year olds. Many major insurance companies now cover this technology, making the artificial pancreas a reality for more T1D patients.
DIY Systems: #WeAreNotWaiting
There is a rapidly-growing group of T1D pump users who decided not to wait for FDA approved closed loop systems and started building their own artificial pancreas systems. Coined the “DIY artificial pancreas” or “looping”, this movement is an open and transparent effort to make basic closed loop technology more widely available.
Patients design their own artificial pancreas, or follow pre-established system protocols posted online.
There are a few limitations to the DIY approach:
- The system only works on older versions of the Medtronic insulin pump that were manufactured from 2006-2012, which are no longer on the market. Many patients resort to buying them secondhand.
- The patient must be technically savvy enough to follow coding protocols to create their own APS.
- There is inherent risk in allowing a non-regulated medical device to automatically control insulin delivery.
Despite these obstacles, many patients report success with DIY systems. They are inexpensive to build, give patients transparency into how their system works, and the momentum in this movement is driving manufacturers to get closed loop solutions to patients faster.
Precision Medicine Treatments
Precision medicine -- the tailoring of medical treatments to individual characteristics of each patient, such as genetic, environmental, and lifestyle factors – is a rapidly-growing field. Recently, the Juvenile Diabetes Research Foundation and IBM kicked off a precision medicine effort to identify T1D risk and onset in children.
Throughout the history of diabetes research, large global data sets have agreed on which factors correlate with T1D. However, this data has never been analyzed on a sufficiently comprehensive scale to understand why some people with risk factors develop the disease, while others don’t.
The new initiative will apply machine learning efforts to years of global T1D research data, with the goal of understanding risk factors and potential causes of T1D.
The starting point is compiling and “cleaning” the data, which will then be searched for patterns to identify subsets of T1D. From there, machine-learning algorithms will describe progression to full blown T1D. This could identify opportunities for the prevention of type-1 diabetes pathogenesis, or new treatments for established disease.
These innovative technologies and collaborations are just a few advances in the research and treatment of T1D this year. Other exciting developments including beta cell replacement and regeneration, immunotherapies, and development of glucose responsive insulin (just to name a few!) are also on the horizon.