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Trial Drug Shows Promise in Preventing Type 1 Diabetes

June 2017

June-2017-Peds-Diabetes-Case-Study-Image-MH Loc 2512Building 0007
— Part of the University of Minnesota Masonic Children’s Hospital campus, the 2512 Building houses the Discovery Clinic and a pediatric diabetes care location.

Contributed by Antoinette Moran, MD

We can predict who will get type 1 diabetes (T1D) by measuring autoantibodies. T1D progresses in 3 distinct phases.1 By the time diabetes is clinically apparent (stage 3), beta cell destruction is already extensive, and the immune system may be “hard-wired” and unable to completely reverse this pattern. The disease progresses faster in children than in adults, making early identification and prompt intervention even more critical for saving function of the pancreas in this population.

Preventing T1D’s progression to clinical onset is the goal of TrialNet, an international network of researchers who offer risk screening for relatives of people with T1D and innovative clinical studies to preserve insulin production. This case study illustrates the experience of one young patient participating in the research initiative.


A young patient, 2 years of age and identified as at-risk for T1D because her brother has the disease, showed the presence of multiple diabetes autoantibodies in her first screening. Her oral glucose tolerance test was normal. By the time she was 3, she was positive for all 5 of the measurable autoantibodies associated with T1D. Her oral glucose tolerance test remained normal, indicating she was in stage I T1D and did not have clinically apparent diabetes (stage 3). As data suggest, however, there is a 70% chance she will have clinical onset of diabetes by age 8 and a 95% chance by age 11.2 The lead physician suggested to the patient’s family that she be enrolled in a TrialNet study evaluating the ability of oral insulin to halt progression of T1D. The clinical team explained that without intervention the progression to hyperglycemia was almost inevitable. The family agreed to the patient’s participation in the study.


The patient began the treatment regime: 2 tablets of oral insulin administered every 2 weeks. She is also monitored through clinic visits every 3 months. After 1 year, the patient now 4 years-old shows no symptoms of T1D. She will continue to be monitored every 3 months as well as in her annual visits. The patient’s older sister is also being monitored, and to date, all her T1D screens have been negative.


Preliminary data suggest that oral insulin may work in much the same way as allergy shots; that is, small frequent exposures to insulin antigen may increase the immune system’s tolerance. Currently, through TrialNet studies, several approaches have been found to slow the immune system’s attack on beta cells in patients with early onset T1D. In TrialNet locations, these drugs as well as other approaches are being used in at-risk sibling participants who still have normal beta cell mass. The immune systems of those in the early phases of diabetes, it is believed, may be more amenable to durable changes. It is hoped that ultimately these approaches will lead to prevention of T1D.

University of Minnesota Masonic Children’s Hospital is conducting 7 TrialNet studies investigating clinical efforts to prevent onset of T1D or preserve remaining beta cells in new onset disease.


  1. Type 1 Diabetes TrialNet. Stages of T1D: The progression of type 1 diabetes. Accessed April 2017.
  2. Wherrett DK, Chiang JL, Delamater AM, et al. Defining pathways for development of disease-modifying therapies in children with type 1 diabetes: a consensus report. Diabetes Care. 2015;38:1975–1985.
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