Objective
1. We will evaluate the accuracy (how close the blood glucose measures obtained through the new device are respect to the ones obtained in a clinical facility)
2. We will also evaluate how painful is the procedure - fingerstick - necessary to collect the blood with the new device respect to the blood draw used during the standard OGTT.
3. We will ask the participants their feelings and ideas about the procedure performed with the new device respect to the standard OGTT
Background Rationale
Clinical type 1 diabetes is preceded by a prolonged non-symptomatic period characterized by the presence of islet autoantibodies (autoimmunity) and a variable range of alteration of blood sugar. Current screening programs identify people at risk for the disease by measuring islet autoantibodies generally with a blood draw, then those positive for two or more autoantibodies are asked to undergo a test - the oral glucose tolerance test (OGTT) - at a clinic facility to evaluate the blood sugar after drinking a standard sugary beverage. This test is of pivotal relevance to identify the "stage" of the disease and to determine the eligibility of people for the only FDA approved treatment able to slow down the progression to clinical diabetes - the anti CD3 teplizumab. This drug is approved for those having a specific range of blood sugar values during the OGTT, thus the ability to identify people who might benefit from the treatment is of paramount relevance.
Additionally, the OGTT is part of the monitoring programs for those at risk for T1D progression (because they carry two or more islet autoantibodies) and, today, this test remains relatively invasive, time and resource consuming, and represents a burden especially for the youngest ones and their families who are required to have the test done at a clinical facility every 6-12 months.
The new GTT@Home device, through guided fingerstick tests, allows home-based OGTT and remote transmission of the blood glucose values obtained during the test (via a dedicated app or by mailing part of the device in an envelope).
Description of Project
Clinical type 1 diabetes is preceded by a prolonged non-symptomatic period characterized by the presence of islet autoantibodies (autoimmunity) and a variable range of alteration of blood sugar. Current screening programs identify people at risk for the disease by measuring islet autoantibodies generally with a blood draw, then those positive for two or more autoantibodies are asked to undergo a test - the oral glucose tolerance test (OGTT) - at a clinic facility to evaluate the blood sugar after drinking a standard sugary beverage. This test is of pivotal relevance to identify the "stage" of the disease and to determine the eligibility of people for the only FDA approved treatment able to slow down the progression to clinical diabetes - the anti CD3 teplizumab. This drug is approved for those having a specific range of blood sugar values during the OGTT, thus the ability to identify people who might benefit from the treatment is of paramount relevance.
Additionally, the OGTT is part of the monitoring programs for those at risk for T1D progression (because they carry two or more islet autoantibodies) and, today, this test remains relatively invasive, time and resource consuming, and represents a burden especially for the youngest ones and their families who are required to have the test done at a clinical facility every 6-12 months.
Herein, we evaluate a new device - GTT@Home - that consists of an home-based self administered test able to guide a person needing the OGTT with a step-wise sequence of instruction and to collect the blood through a fingerstick. The system records the blood glucose data and a provider can later access to them once they are either uploaded via a dedicated app (e.g. through a smartphone) or via mail. However, this device is not yet part of our clinical practice. We will evaluate its accuracy (how close the blood glucose measures obtained through the device are respect to the ones obtained in a clinical facility). We will also evaluate how painful is the procedure - fingerstick - necessary to collect the blood with the new device respect to the blood draw used during the OGTT. Lastly, we will ask the participants their feelings and ideas about this procedure respect to the standard OGTT.
If this device will be proven to be accurate and if it will be well accepted by the participants, we could consider its use in larger screening and monitoring programs for the risk of T1D, extending the outreach of current programs and offering to a broader number of people, including those living in remote areas, the access to the test at a lower cost.
Anticipated Outcome
We expect that the blood glucose measures obtained with the new GTT@Home device will be similar to the one deriving from the standard OGTT with a negligible difference. Additionally we expect that the procedure with the GTT@Home device will be better tolerated by the participants than the standard OGTT and that they will ultimately prefer the home-based test over the in clinic OGTT.
Relevance to T1D
If this device will be proven to be accurate and if it will be well accepted by the participants, we could consider its use in larger screening and monitoring programs for the risk of T1D, extending the outreach of current programs and offering to a broader number of people, including those living in remote areas, the access to the test at a lower cost.
An home-based OGTT will facilitate general population screening and monitoring, will allow the identification of people potentially eligible for disease modifying treatments and will contribute to abate the barriers that prevent people to access screening and monitoring programs. Barriers include the absence of a clinical site in close proximity, the need for days off to access the clinical site and perform an OGTT, the invasiveness and burden associated to the standard OGTT.
GTT@Home, if proven accurate and well accepted, may overcome these major obstacles to T1D screening and monitoring.