Drug Delays Diabetes Type 1 Onset

The head of the Food and Drug Administration (FDA) has approved the drug Teplizumab (Tzield) that can delay the onset of Type 1 Diabetes. Approval of the drug represents an additional step in the advance of medical research into diabetes that has strived for many years to try to understand the disease and its causes in order to enable innovative treatment, such as the artificial pancreas and preventive care trials whose aim is to delay the onset of the disease.

Last year, in collaboration with child health centers and Clalit community clinics, Schneider Children's initiated research led by Prof. Moshe Phillip and Dr. Tal Oron from the Institute of Endocrinology and Diabetes, together with Prof. Avner Cohen from the community, which showed that a simple blood test can predict the risk of future onset of Type 1 Diabetes with an 85% certainty. Early evaluation is expected to lower the percentage of a serious complication called diabetic ketoacidosis (DKA) to under 5%, compared with today where 40% of diabetics at Schneider Children's suffer from this life-threatening condition.

DKA is manifested by nausea and vomiting, heightened thirst and hyper-urination, stomach aches, respiratory distress and sometimes also unconsciousness. It has a long-term impact leading to diminished metabolic balance, increased risk of heart and vascular disease and impaired cognitive function.

Early diagnosis is key to the ability to prevent the onset of DKA and its long-term complications, morbidity and hospitalizations. In those children found to be at risk of developing diabetes, the percentage of DKA at diagnosis is expected to decrease to under 5%. The blood test is for infants aged 9-18 months and is performed together with a blood count invariably done at this age and without any need for further tests. In the coming months, the test will be expanded to include children up to the age of 5 years. The test is done using innovative technology based upon PCR which identifies antibodies in the pancreas via a tiny drop of blood.

Since the initiation of the research up until today, 29 designated clinics have opened around the country with close to 160 staff members in community clinics as part of the project, with the aim of expanding to other centers. Similarly, tests have been done in 2500 children, where 10 of them were found to have positive antibodies against the pancreas. The children were referred for follow-up to Schneider Children's and other diabetic centers participating in the study including Tel Hashomer, Ichilov, Soroka, Rambam, Haemek and Hadassah Ein Kerem. The centers provide responses to children found at risk of childhood diabetes onset and their families, offer guidance, monitor signs for diabetes, stress evaluation and psychosocial assistance for parents.

Prof. Phillip, Director of the Institute of Endocrinology and Diabetes at Schneider Children's, noted that "the potential of this drug to delay the clinical diagnosis of Type 1 Diabetes can provide patients with an average of 3 years without the chronic burden, risks and complications of the disease, and therefore the FDA's approval is no less than an important turn and breakthrough that we all hope is the first sign marking the beginning of the era of paradigm change in the treatment of Type 1 Diabetes. The FDA's approval emphazises the relevance and great importance of research that we started last year for the early, effective and simple identification of childhood diabetes. The close accompaniment of children at risk of diabetes within the framework of the research assists in the prevention of acidosis in many patients diagnosed late. The approval of the FDA now also accords a solution to children who can enjoy this novel treatment and in the future, also perhaps other new therapies to prevent diabetes."