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

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $224,611

## Abstract

Project Summary
Recent data suggest that diabetes is common in patients hospitalized with severe COVID-19 illness, and
hyperglycemia during hospitalization has been associated with poor outcomes in this patient population. As with
other infections, ensuring good glycemic control will be important for optimizing the care of patients admitted with
COVID-19; however, frequent glucose monitoring is time consuming, requires donning of personal protective
equipment (PPE), and exposes healthcare workers to infection. The Dexcom G6 Continuous Glucose Monitoring
(CGM) System provides real-time glucose data every 5 minutes and is approved for use in patients ages 2 and
older in the outpatient setting. The FDA has recognized the potential value of using CGM to allow hospital staff
to remotely monitor glucose in inpatients with COVID-19, releasing a statement that they will not object if CGM
companies provide devices and technical support to hospitals who want to implement CGM for glucose
monitoring to support COVID-19 healthcare efforts. Using the Dexcom G6 to monitor patients’ glucose levels
remotely in real-time could significantly improve diabetes management by alerting providers to high or low
glucose values, reducing the burden of frequent in-person fingerstick glucose checks, limiting viral exposure of
healthcare providers, and conserving PPE. However, given the lack of data confirming the accuracy of this device
in the hospital setting, particularly in critically ill patients with COVID-19, the introduction of this technology into
clinical use in the hospital and ICU setting requires a systematic approach to evaluate accuracy and safety prior
to widespread use.
We have developed a plan for introducing the Dexcom G6 into clinical use at Massachusetts General Hospital
(MGH), using iterative quality assurance processes and comprehensive data collection to ensure safety and
efficacy in this population. This will provide timely, real-life data to guide other health care organizations in the
use of this technology during the COVID-19 crisis. In this proposal, we will pursue the following three aims: (1)
we will establish the accuracy of the G6 CGM in patients admitted in an ICU and on a medical floor, identifying
factors that may impact CGM accuracy and instituting a calibration protocol to improve accuracy if needed; (2)
we will investigate the feasibility of non-adjunctive use of the Dexcom G6 in critically ill and non-critically ill
patients admitted with COVID-19; and (3) we will evaluate the safety and efficacy of the Dexcom G6 in
hospitalized patients with COVID-19 in a nested case-control study of patients with diabetes admitted to MGH.
The data collected in this proposal will provide critical information guiding Aim 3 of the parent grant, which
proposes to study an artificial pancreas device, the bionic pancreas (BP), in patients with cystic fibrosis related
diabetes. Similar to those with COVID-19, patients with CF are often hospitalized with resp...

## Key facts

- **NIH application ID:** 10177522
- **Project number:** 3R01DK119699-02S1
- **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:** $224,611
- **Award type:** 3
- **Project period:** 2019-01-16 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10177522

## Citation

> US National Institutes of Health, RePORTER application 10177522, Clinical studies of a bionic pancreas for automated glucose management in cystic fibrosis-related diabetes mellitus (3R01DK119699-02S1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10177522. Licensed CC0.

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