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Clinical studies of a bionic pancreas for automated glucose management in cystic fibrosis-related diabetes mellitus

Award Number: R01DK119699
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/16/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2024

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Clinical studies of a bionic pancreas for automated glucose management in cystic fibrosis-related diabetes mellitus - Project Summary Cystic fibrosis (CF) is the most common autosomal recessive disease affecting Caucasian populations and causes progressive pulmonary decline and multi-organ disease leading to premature death. Cystic fibrosis- related diabetes (CFRD) affects up to half of adults with CF. Development of CFRD is associated with clinical deterioration including decline in pulmonary function, compromised nutritional status, and increased mortality. Insulin is the only recommended treatment for CFRD and has been demonstrated to improve clinical status and decrease mortality. Patients with CF already carry a significant medical burden managing the pulmonary manifestations of their disease, and the additional onus of frequent blood sugar monitoring and insulin injections that accompanies CFRD often leads to a decline in quality of life and non-adherence. One of the most promising strategies to improve glycemic regulation in people with type 1 diabetes (T1D) is automation of glycemic regulation with artificial pancreas (AP) devices. We have tested an AP device called the bionic pancreas extensively in subjects with T1D and have shown that it simultaneously reduces both mean glucose and hypoglycemia while reducing the work required for diabetes management and improving quality of life. There are several unique features of the bionic pancreas that make it ideally suited among AP systems for use in the CFRD population. The bionic pancreas rapidly and automatically adapts to a wide range of insulin needs, making it well suited to address fluctuations in insulin requirements of those with CFRD that occur during acute CF exacerbations and treatment with glucocorticoids. In addition, it is not necessary to carbohydrate count or inform the bionic pancreas when a meal is going to be eaten to achieve good glycemic control, which will be particularly useful for patients with CF who require frequent high calorie, high carbohydrate meals and snacks to maintain an adequate nutritional status. Moreover, the bihormonal configuration of the bionic pancreas, which can use micro-dose glucagon to prevent hypoglycemia when suspension of insulin delivery is insufficient, may be particularly useful for prevention of hypoglycemia in patients with CFRD, who are already at high risk for hypoglycemia due to pancreatic fibrosis leading to glucagon deficiency. In this proposal we will test the ability of the bionic pancreas to control blood glucose levels in subjects with CFRD with the following three aims: (1) We will test the short-term safety and efficacy of two configurations of the bionic pancreas, bihormonal (insulin/glucagon) and insulin-only, versus usual care in subjects with CFRD; (2) we will compare the long-term outpatient performance of the bionic pancreas versus usual care over a period of 6 months and look for preliminary evidence of improvement in non-glycemic outcomes such as pulmonary function, weight, and number of CF exacerbations; and (3) we will compare the bionic pancreas to usual glycemic inpatient management in patients with CFRD during hospitalizations for CF exacerbations, which are often associated with difficulty in glycemic management.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	4/14/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $579,793 )
2024	2024	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	2/1/2024	NON-COMPETING CONTINUATION	$543,555
2024	2024	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	5/17/2024	NON-COMPETING CONTINUATION	$36,238
														Subtotal = $579,793

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	1/6/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $603,951 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	12/21/2021	NON-COMPETING CONTINUATION	$543,555
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	4/6/2022	NON-COMPETING CONTINUATION	$60,396
														Subtotal = $603,951

Issue Date FY: 2021 ( Subtotal = $647,610 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	2/12/2021	NON-COMPETING CONTINUATION	$647,610
2021	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	2/12/2021	NON-COMPETING CONTINUATION	$0
2021	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	10/23/2020	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $647,610

Issue Date FY: 2020 ( Subtotal = $901,901 )
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	8/7/2020	SUPPLEMENT FOR EXPANSION	$224,611
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/23/2019	NON-COMPETING CONTINUATION	$609,560
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	2/10/2020	NON-COMPETING CONTINUATION	$67,730
														Subtotal = $901,901

Issue Date FY: 2019 ( Subtotal = $647,947 )
2019	2019	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/16/2019	NEW	$616,761
2019	2019	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	8/20/2019	SUPPLEMENT FOR EXPANSION	$31,186
														Subtotal = $647,947

Grand Total All Awards = $3,381,202

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Clinical studies of a bionic pancreas for automated glucose management in cystic fibrosis-related diabetes mellitus

Award Number: R01DK119699

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/16/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2024

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