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Improved screening efficiency for type 1-diabetes with simplified blood draw

A woman gives a blood sample.
Current screening methods require multiple blood samples. New research shows that a fingerstick blood test can be sufficient. Photo: Petra Olsson

Diabetes researchers have established methods for screening people with an increased risk of developing type 1-diabetes. Current methods require multiple blood samples during each visit. An international team of researchers has developed a simplified screening method, which will increase screening efficiency.

Type 1-diabetes is a disease that requires lifelong treatment with insulin. People of all ages can develop the disease, and the symptoms are not always obvious. Current screening methods have been established in a research context to identify people at risk and are costly and logistically difficult. An international team of researchers have now developed a simplified test. 

“Instead of obtaining multiple blood samples via a vein during each visit, we now know that a fingerstick blood test will be sufficient. This means that the screening process will lessen the discomfort some of our participants may be feeling,” says Åke Lernmark, senior professor in experimental diabetes at Lund University, and corresponding author for the study.

Follows the disease progression

The study, published in the scientific journal Diabetologia, is based on data from participants in the four studies DPT-1, Trialnet, Teddy and Fr1da. The participants were up to 45 years of age and had reached the first or second stage of type 1-diabetes. A clinical diagnosis can be made when a person reaches the third stage.

Participants in screening studies will undergo oral glucose tolerance tests (OGTT) a couple of times a year to determine the disease stage. The test require that the person has been fasting prior to the OGTT. The first blood sample will measure the blood glucose level. The next stage is to take a glucose drink. Further blood samples will be taken at regular intervals of 30, 60, 90 and 120 minutes to follow-up the blood glucose level.

Sample with highest accuracy

The researchers have compared a large amount of oral glucose tolerance tests performed by around 3500 persons over several years. Their analysis shows that the blood sample taken two hours after the glucose drink could predict the disease risk with highest accuracy.

“For several years, we have believed that multiple blood samples will increase the accuracy of the OGTT. Now, it turns out that the blood sample taken two hours after the glucose drink predicted a clinical diagnosis with the highest accuracy. This came as a surprise to me and my research colleagues,” says lead author John Wentworth from Royal Melbourne Hospital and Walter and Eliza Hall Institute in Australia. 

Screening for type 1-diabetes is increasing in countries such as the United States. In Sweden, the method is mainly used to predict the disease within a research context. An example of this is the international research project Teddy, financed by National Institutes of Health (NIH) in the United States. The study is being carried out in Sweden, Finland, Germany and the United States. In Sweden, there is currently no screening programming within the health care system aimed at people with an increased risk of developing type 1-diabetes. 

“The Swedish health care system does not screen for diseases that cannot be prevented, stopped or cured. There is no cure for type 1-diabetes, but an early discovery of the disease will lessen the risk for complications,” says Åke Lernmark, researcher at Lund University Diabetes Centre (LUDC).

Important knowledge

If type 1-diabetes is left untreated, the blood glucose levels can get very high. This can lead to diabetic ketoacidosis (DKA), a potentially life-threatening condition. The Teddy-study is following children at risk and aims to discover the disease at an early stage. 

“Many of the parents express gratitude, as they feel more prepared when the disease appears. We have heard parents saying, ‘Thanks to Teddy, we haven’t had to sit and wait at the emergency department for a child that has become very ill with ketoacidosis,’” says Åke Lernmark, principal investigator for the Teddy-study in Sweden.

The simplified method will be useful for the researchers in the process of learning more about the development of the disease. The knowledge is important for the strategic research area Exodiab at Lund University. The mission of Exodiab is to prevent and cure diabetes.

“Our new simplified method will increase screening efficiency, which will save us time and resources. We hope this will speed up our efforts to prevent the disease,” says Åke Lernmark, who is part the research environment Exodiab.

The study in Diabetologia

The study "Simplifying prediction of disease progression in pre-symptomatic type 1 diabetes using a single blood sample" is published in the scientific journal Diabetologia, august 2021, DOI: https://doi.org/10.1007/s00125-021-05523-2
 

Type 1-diabetes

Type 1-diabetes is caused by an autoimmune reaction in which the body’s immune system attacks the insulin-producing beta cells of the pancreas. As a result, the body produces very little or no insulin. People with type 1-diabetes need daily insulin injections to maintain a glucose level in the appropriate range.

Three disease stages have been defined. Stage one is defined by normal glucose tolerance and two or more islet autoantibodies. An individual with two or more islet autoantibodies and impaired glucose tolerance has reached the second stage. Stage three satisfies current diagnostic criteria and is usually accompanied with symptoms of hyperglycemia.
 

Quick facts about the study

Subject: Type 1-diabetes (autoimmune diabetes)
Research area: Clinical research
Study design: Quantitative study, researcher-initiated study, statistical link
Experimental investigation: In vivo
Observational study: Prospective, longitudinal, healthy volunteers
Number of patient groups: Four groups. 601 individuals from DPT-1, 2684 persons from Trialnet (TN-01), 209 from Teddy and 80 individuals from Fr1da. 
Total number of volunteers: 3574
 

Photo of researcher Åke Lernmark.

Contact

Åke Lernmark, senior professor in experimental diabetes at Lund University
+46 40 39 19 01
+46 706 16 47 79
ake [dot] lernmark [at] med [dot] lu [dot] se