Type 1 Diabetes Clinical Research

We have come so far with developing artificial pancreas technology and investigational drug products that can preserve pancreas cell function, but we still have a long way to go.

I’m so excited to be a part of that hopeful journey working as a clinical research nurse with Type 1 diabetics.  I work on studies that are in phase 1 of research (which means that it is the first medication trial in humans) all the way up to phase 3 research studies (right before the FDA approves the medication for use).

When I try to explain my job to others, I often find that the general public does not know the difference between Type 1 and Type 2 diabetes.

Type 1 diabetes is vastly misunderstood because it is less common than Type 2 diabetes. The CDC states that only 5-10% of total diabetes cases are Type 1. I work with that small population, as well as the family members who are at risk for developing Type 1.

Let’s start out with what Type 1 diabetes is NOT

Type 1 diabetes is not Type 2 diabetes.

In Type 2 diabetes, the pancreas still produces insulin. The problem is not the insulin production, but instead it is the fact that the body’s cells have stopped responding to the insulin. Since the cells are insulin resistant, the body cannot use the insulin to break down the sugar circulating in the blood. All the extra insulin signals the body to store more sugar in fat cells leading to more body fat. Type 2 diabetes can be greatly improved by lifestyle changes like exercise, eating healthy foods, and weight loss. The treatment goal for Type 2 diabetes is to increase insulin sensitivity: the insulin is there, it’s just not being recognized by the body.

I can’t stress this enough: Type 1 diabetes is different than Type 2 diabetes.

Type 1 diabetes (T1D) is an autoimmune disease, in which the body attacks its own cells in the pancreas. The pancreas slowly loses its ability to produce insulin. This is a problem of insulin production: there simply is not enough insulin. Those who are just diagnosed might go through a “honeymoon phase,” where their pancreas still has some ability to make insulin and the patient has less need for external insulin. Over time, though, the body becomes more and more dependent on external insulin to regulate blood sugars as those pancreatic cells are destroyed.

Who is at risk for T1D?

I can share a few things that we assess in our TrialNet: Pathway to Prevention study, which is a large research study focused on identifying and monitoring those who are at risk of developing T1D.

Genetics plays a role in T1D occurrence. TrialNet research has found that the risk of T1D development is 15 times greater for family members than the general public. Additionally, we look for blood markers (“autoantibodies”) at our screening visits, which show up when the body starts attacking the pancreas and activating the immune system. If someone’s blood has autoantibodies, he/she is eligible to participate in monitoring. In the monitoring phase, we check blood sugar levels and autoantibodies on a semi-annual or annual basis to observe whether or not their risk of developing T1D has changed.

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T1D development is looked at in stages.

Stage 1 is the presence of the autoantibodies – the blood markers, that signal the body is attacking its own cells.

Stage 2 is the development of abnormal blood sugars. We have participants in stage 2 come in twice a year to perform oral glucose tolerance tests. This visit is usually 2-3 hours, and it requires them to come in after fasting for 10 hours. Once an IV is started, the participant must drink a very sugary liquid within 5 minutes, and we take blood samples over the course of the next few hours to see how their body is responding.

Stage 3 is the clinical diagnosis of T1D, in which pancreatic cells have been greatly damaged and insulin supply is declining. Common symptoms in stage 3 are increased urination, increased thirst, unexplained weight loss, and extreme fatigue.

The goal of early monitoring is to reduce the occurrence of Diabetic Ketoacidosis (DKA). This is a very scary condition that happens when blood sugars are really high for too long. When the bloodstream is overloaded with sugar (because there is no insulin to break it down), the body has to use fat for fuel. As the body uses fat for fuel, ketones are created in the body and high levels of ketones are extremely dangerous. Early signs of DKA include dehydration, thirst, and urination; this can progress to fruity breath, confusion, fatigue, nausea, vomiting, and in severe cases, coma. DKA often leads to hospitalization. With early monitoring through research studies, TrialNet has found that the occurrence of DKA at diagnosis drops from 30% to 3%.

There is currently no treatment for T1D, which makes the research field so exciting to be a part of.

I am on the front line of both technology and medication that have the potential to greatly improve the lives of those living with T1D.

Other T1D websites to check out:

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