Restoring awareness of hypoglycemia in type 1 diabetes
Active Cooperative Agreement Awarded Last action
- Award ID
- U01DK135120
- Recipient
-
The Trustees Of The University Of Pennsylvania UEI GM1XX56LEP58
- Awarding agency
-
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health, Department of Health and Human Services
- Obligated
- $4,551,243
Award facts
- Assistance listing
- 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research
- Completion date 78% complete
- Originally
- Place of performance
- Pennsylvania, USA
Award details come from USAspending.gov.
Description
- Abstract
- This application "restoring awareness of hypoglycemia in type 1 diabetes" proposes to elucidate the heterogeneity of impaired awareness of hypoglycemia (IAH) in type 1 diabetes through completion of a 24-month sequential multiple assignment randomized trial (smart) designed to better inform our understanding of the clinical and physiologic factors which contribute to restoration of counterregulatory defenses against hypoglycemia in response to educational, technologic, and pharmacologic interventions. Given the persistent barrier of hypoglycemia to the realization of achieving adequate glycemic control for most individuals with type 1 diabetes, there is a critical need to further understand the mechanisms contributing to hypoglycemia in type 1 diabetes in order to advance treatment approaches that may realize the benefits of near-normal glycemic control without the accompanying risk for severe hypoglycemia. The present proposal aims 1) to determine whether counterregulatory responses to a hyperinsulinemic hypoglycemic clamp can be restored in individuals with long standing type 1 diabetes and IAH using an adaptive randomized clinical trial design implementing state-of-the- art interventions including hypoglycemia avoidance education (standard-of-care; SOC), automated insulin delivery with hybrid closed loop technology (HCL), and novel mini-dose glucagon (MDG) pharmacology; 2) to determine the physiological factors associated with improved counterregulatory responses following intervention, including but not limited to age, diabetes duration, and continuous glucose monitoring (CGM) metrics; and 3) to validate a hypoa-q short form questionnaire as a self-report measure for identifying IAH with measurement of counterregulatory responses derived from the hypoglycemic clamp. The proposed smart study design will allow for rigorously determining both the degree of hypoglycemia avoidance necessary for improvement of counterregulatory epinephrine and autonomic symptom responses to insulin-induced hypoglycemia, as well as the additional factors such as age, diabetes duration, other CGM metrics, and validated IAH self-report that may predict individual responsiveness to SOC, HCL, and MDG interventions.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $731,968 | |
| Amendment | $568,303 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $813,114 | |
| Amendment | $813,114 | |
| Amendment | $813,114 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $405,815 | |
| Original award | $405,815 |
Show all 12
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Visiting Nurse Service Of New York | $34,290 | |
| Visiting Nurse Service Of New York | $34,290 |
Quick answers
Who received award U01DK135120?
U01DK135120 was awarded to The Trustees Of The University Of Pennsylvania by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on September 25, 2022.
How much is award U01DK135120 worth?
$4,551,243 has been obligated on U01DK135120.
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