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

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $677,290

## Abstract

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
bion...

## Key facts

- **NIH application ID:** 9850967
- **Project number:** 5R01DK119699-02
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Melissa Susan Putman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $677,290
- **Award type:** 5
- **Project period:** 2019-01-16 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9850967

## Citation

> US National Institutes of Health, RePORTER application 9850967, Clinical studies of a bionic pancreas for automated glucose management in cystic fibrosis-related diabetes mellitus (5R01DK119699-02). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/9850967. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*