Medically reviewed by Anna Goldman, MD.
Once upon a time, type 1 diabetes (T1D) wasn’t easily diagnosed until blood glucose levels were dangerously high with identifiable symptoms — like intense thirst, frequent urination, unexplained weight loss, insatiable hunger, and fatigue.
Today, the earliest stages of T1D can be spotted with a simple blood test months or years before the need for daily insulin therapy. But convincing the general public to screen their children or themselves isn’t easy — especially considering most people think it simply won’t happen to them or their children.
While many organizations are working to implement routine screening for the autoantibodies that develop in earlier stages of type 1 diabetes, before the onset of symptoms, most clinicians probably wouldn’t know what to do with those results.
Recently, leading diabetes organizations from across the globe have collaborated and developed clear guidelines for monitoring children and adults who test positive for stage 1 and stage 2 of T1D based on autoantibody results.
“It’s exciting to have a consensus on this guidance that is endorsed by the leading medical journals and organizations globally,” explains Anastasia Albanese-O’Neill, Associate Vice President, Community Screening and Clinical Trial Education, Breakthrough T1D (formerly JDRF). ”We’re really grateful that everyone leaned in and came to this consensus, recognizing the gaps in T1D monitoring, and care for people in early stage T1D.”
Let’s dig in.
Spotting T1D Before Symptoms Develop
It starts with screening for autoantibodies that indicate stages 1 and 2 of T1D. Autoantibodies develop when your immune system begins attacking your own body.
Through decades of research, experts have identified the key autoantibodies related to T1D —and at this time believe most people who will eventually develop T1D test positive for those autoantibodies before age 5.
Even if you have T1D and you know the symptoms, it’s worth getting your children and extended family screened. (By the way, I’ve tested my children for autoantibodies three times each before they were 6 years old.)
Stage 1 and stage 2 of type 1 diabetes are also referred to as “early stage type 1 diabetes” or “presymptomatic type 1 diabetes.”
Almost everyone with two or more T1D autoantibodies will eventually progress to stage 3 type 1 diabetes, when insulin is required. The stages are determined by how much the autoimmune attack has affected your blood sugar levels:
Stage 1: Testing positive for two or more autoantibodies with normal blood glucose levels.
Stage 2: Testing positive for autoantibodies with abnormal blood glucose levels but no identifiable symptoms. Glucose levels are not significantly or consistently high.
Stage 3: Presenting with clear symptoms of T1D, consistently high glucose levels, and an immediate need for daily insulin therapy.
How can you or your child get screened? There are a few ways to go about it these days — in a blood lab or at home. Visit BreakthroughT1D.org/screening to find the best option for you and your family.
If a person tests positive for stage 1 or 2, what’s next? That’s where this consensus report’s protocol comes into action.
New Protocol: When to Start Insulin Therapy
If you or a family members are in the first or second stage of type 1 diabetes, the new recommended protocol to monitor the condition’s progression includes the following:
Establish a relationship with your primary care provider to support all ongoing monitoring until the development of stage 3 T1D. Primary care providers should be able to support all monitoring needs. Primary care physicians can consult endocrinologists as needed.
Confirm positive results within three months with an additional test. Ideally, this second test is done with an intravenous blood draw — not a finger stick — to ensure its accuracy. It should be done in a laboratory familiar with standards established by the “Islet Autoantibody Standardization Program” (IASP) to ensure the accuracy of the test.
Monitor the progression from one autoantibody to two autoantibodies with continued screening. The progression of one to two autoantibodies is a critical detail because it increases the likelihood of blood glucose fluctuations and the eventual need for insulin therapy. The rate at which T1D progresses from stage 1 to stage 2 can vary significantly in children.
Consider therapies that prolong insulin production and increase insulin sensitivity, specifically tepluzimab (Tzield), or seek out clinical trials testing therapies to delay or treat early type 1 diabetes progression in people aged 8 and older.
Monitoring
Children
Adults
Note
Daily or weekly Glucometer Testing
Starting at stage 1
Starting at stage 1
Especially during additional illness, like the flu or a cold.
HbA1C testing
Stage 1:
Under 3 years old: Once every 3 months
3-9 years old: every 6 months
9 and up: once per year
Stage 2:
every 3 months
Stage 1: once per year
Stage 2: every 6 months
Random venous or capillary blood glucose should be measured at the same time as HbA1C
A1C insights
Increase from 5.0 to 5.5% suggests full progression to stage 3 T1D within one year. Follow with Oral Glucose Tolerance Test if possible as this is the gold standard.
A 10% increase in A1C level indicates disease progress and should be followed with an Oral Glucose Tolerance Test
Examples of 10% increase:
5% A1C x .10 = 5.5%
6% A1C x .10 = 6.6%
CGM monitoring
Starting at stage 2: 10-14-day blinded CGM monitoring with clinician
Starting at stage 2: 10-14-day blinded CGM monitoring with clinician
When to start insulin
Diagnosis of stage 3 type 1 diabetes
A1C at/above 6.5%
In some cases, DKA can develop before A1C levels rise. DKA indicates the need for daily insulin therapy.
A1C at/above 6.5%
In some cases, DKA can develop before A1C levels rise. DKA indicates the need for daily insulin therapy.
Some clinicians and countries may have differing approaches for when to start insulin therapy.
This process can be daunting and overwhelming as you anticipate the inevitable need for daily insulin therapy. Let your healthcare team support you and remember: People with T1D can live very full, successful, happy lives! It’s all about learning. Bit by bit.
Getting Screened Matters — Before Symptoms Develop!
Most of us with type 1 diabetes had already endured months or weeks of high blood glucose levels and diabetic ketoacidosis (DKA) by the time we were diagnosed. By identifying T1D in stage 1 or 2, a person can start insulin therapy to prevent severe high blood glucose levels or DKA.
Sure, you might already know the symptoms of T1D, but screening is about diagnosing the earlier stages so you or your child do not have to spend several weeks, months, or years with dangerous or life-threatening blood sugar levels.
“With screening, we can prevent diabetic ketoacidosis [DKA], we can invite people to participate in clinical trials that might delay the need for daily insulin therapy, and we can offer them FDA-approved medications that delay needing insulin,” explained Albanese-O’Neill.
Today, Tzield is the only therapy FDA-approved to delay the full onset of T1D — by an average of 4 years compared to 2 years on the placebo. An ongoing trial is also looking at Tzield’s potential Unfortuantely, insurance companies are resistent to offer coverage for such a new therapy — which costs $200,000 for the 14-day infusion process. It is not an easy drug to access or an easy process to endure for a parent and child.
Some day there may be more options. More and more clinical trials are evolving with a focus on the earliest stages of T1D — including Diamyd Medical’s GAD-65 therapy and multiple trials focused on semaglutide.
If you or your child get a positive result on your autoantibody screening, your local healthcare team can refer to this newly published consensus to monitor and support you.
“We don’t want anyone to be alone with a positive result,” added Albanese-O’neill. “If you do get a positive result, you need a partner in healthcare. The consensus also includes [recommendations for] psychological support.”
These guidelines apply to all ages, including children, teenagers, adults, and during pregnancy.
“We know there are two age groups where T1D diagnoses peak,” said Albanese-O’neill. “The first is in [preteen or early teen years], and the second peak age is actually in your 40s and 50s.”
In adults, it is well understood that T1D develops significantly more slowly — making it easy to misdiagnose as type 2.
“I know a woman who had twins with T1D, and she also tested positive for two autoantibodies. Twenty years later, she still doesn’t need insulin, but she is in stage 2 type 1 diabetes,” said Albanese-O’neill.
By the Way, Anyone Can Develop T1D
Did you know that 50 percent of new T1D diagnoses are in people over 18 years old? T1D is frequently misdiagnosed as T2D in adults because of outdated beliefs that it only develops during childhood. Adults with T1D can also have many common observable features of T2D, like obesity, high cholesterol, insulin resistance, and high blood pressure.
T1D also tends to progress slowly in adults. This means you could go years without insulin therapy while managing changes in diet and exercise and with medications intended for T2D. At a certain point, those treatments will no longer be effective and blood glucose levels will rise while insulin production declines. This is especially common for those with a subtype of T1D known as LADA (latent autoimmune diabetes in adults).
Clinicians can easily run tests to confirm or rule out a type 1 diabetes diagnosis, but sometimes it may require some advocacy on your part.
Screening Can Be Scary — But Knowledge is Power
You might be thinking, “Well, I don’t want to find out early because then I’ll just worry about it.”
Well, sure, it’s a very overwhelming process, but ignoring it won’t help. With early screening, you and your family have the power to intervene, to take action through medications that help preserve insulin production, and to prevent dangerous high blood glucose levels and DKA.
Take action. Get screened.
Philip M, et al. Consensus Guidance for Monitoring Individuals With Islet Autoantibody–Positive Pre-Stage 3 Type 1 Diabetes. Diabetes Care. June 24, 2024.
Ross C, et al. The Prevalence of Islet Autoantibodies in Children and Adolescents With Type 1 Diabetes Mellitus: A Global Scoping Review. Frontiers in Endocrinology. February 3, 2022.
Ramos EL, et al. Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes. New England Journal of Medicine. October 18, 2023.
DiMeglio LA, et al. Type 1 Diabetes. The Lancet. July 28, 2019.