Purpose
This FOA will support the conduct of clinical trials designed to test the clinical safety and efficacy of artificial pancreas (AP) device systems with the objective of improving glycemic control, reducing acute complications and improving quality of life in people with difficult to control T1D when using standard of care therapies.
Background
Once established, type 1 diabetes (T1D) requires daily insulin administration and episodes of hyperglycemia and hypoglycemia are common. As a result, patients with T1D without adequate control may suffer devastating acute complications such as life-threatening hypoglycemia and ketoacidosis and long term complications including accelerated cardiac and peripheral vascular diseases, nephropathy, retinopathy, neuropathy, amputation and premature death. Studies such as the Diabetes Control and Complications Trial (DCCT) and the UK Prospective Diabetes Study (UKPDS) have shown that long term microvascular and macrovascular complications can be reduced through tight blood glucose control. However, the increased risk of hypoglycemia that is associated with tight control and the limitations of current glucose control technologies make tight control difficult to achieve. Thus, there is a need for tools to help more people with T1D to safely achieve and sustain tight blood glucose control and reduce burden of care.
New portable/ wearable technologies to measure glucose levels and adjust delivery of insulin and other glucose regulating hormones through an automated closed loop-artificial pancreas system have become available recently and initial clinical testing has shown promising results indicating improved maintenance of close to normal glucose levels with less variability when compared with non- automated open loop systems. These results are very encouraging as it is expected that an effective wearable automated system may lead to a reduction of the risk and incidence of acute and chronic complications and to a significant improvement of the quality of life through mitigation of the burdens associated with diabetes management. However, most of those studies have excluded individuals with diabetes with difficult to control glycemia such as people with elevated HbA1c, frequent severe episodes of hypoglycemia, impaired awareness of hypoglycemia, frequent ketoacidosis, autonomic neuropathy including the presence of gastroparesis and comorbidities. Also, pregnant women with diabetes is a cohort that clearly would benefit from the therapeutic application of these novel diabetes control technologies as they are optimized. This RFA objective is to encourage the conduct of pilot and advanced clinical trials in subsets of individuals with T1D that do not reach acceptable control with current standard of care and open loop non-automated systems.
NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html ). Only applications proposing therapeutic clinical trials will be supported by this FOA. A therapeutic trial has a goal of determining clinical safety, tolerability, efficacy and/or effectiveness of an intervention. Such studies may be pragmatic trials where the intervention is tested under the usual conditions in which it will be applied, or explanatory trials where the intervention is tested under idealized circumstances.
Key Dates
URL for more information
https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-19-036.html
Filed Under: Funding Opportunities