Type 1 Diabetes
Conditions
Keywords
Stage 1 diabetes, stage 2 diabetes
Brief summary
We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D). Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.
Interventions
None listed
Sponsors
Provention Bio, Inc.
Rabin Medical Center
Study design
Observational model
FAMILY_BASED
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
2 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* First degree family member (sibling or parent) of a known T1D patient * Age 2-45 years * Signing an informed consent
Exclusion criteria
* Known diabetes of any kind (type 2, MODY) * Have a previous history of being treated with insulin or oral diabetes medications. * Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive Islet Autoantibodies | Screening visit |
Countries
Israel
Contacts
Primary ContactAlona Hamou, Msc
Outcome results
None listed