Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign (CGM)

September 26, 2025 updated by: Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
This program will provide patients with type 1 and high risk type 2 diabetes the safest hospitalization by using wireless continuous glucose monitoring devices (CGM) to track their glucose parameters in real-time similar to other continuously monitored vital signs. The CGM will inform a team of health professionals who will monitor the patients' progress, communicate recommendations, and be available for discussion when recommended targets are not achieved. Health teams will utilize sensor results in addition to existing electronic medical records data to evaluate progress and manage care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients with type 1 or type 2 diabetes who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by an advanced practice diabetes nurse for glucose management during their hospitalization. All patients included in the study will receive a CGM. Patients with type 2 diabetes will be randomized to control (blinded CGM glucose values to APN, care team and researchers) or intervention (CGM blood glucose values will be used to aid with glucose management during the hospitalization). In addition, a research only supplemental order set will be implemented for all study participants. The order set focuses on any glucose point of care test that is between 70-79 mg/dL or ≥ 250 at bedtime or before the 4 am usual care blood glucose check. The goal is to prevent hypoglycemia and hyperglycemia for all study patients. The advanced practice diabetes nurse will work with the physician in charge of the patient's care as well as the patient's care team.

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Expected length of hospital stay of at least 48 hours

  • One of the following:

    1. Diagnosed with diabetes type 1 OR
    2. Diagnosed with diabetes type 2, with an HbA1c > 8% or 3 point-of-care blood glucose (POC) > 200, and requiring insulin during this hospitalization.
  • Literate in English or Spanish

Exclusion Criteria (not all listed):

  • Pregnant or post-partum
  • Patient admitted to OB unit
  • Patient in ICU or with insulin drip
  • Known allergy to adhesives
  • Anticipated CT/MRI/diathermy procedure within 48 hours from admission (patients with a planned operation within 48 hours from admission may be included in the study post operation).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
For type 2 patients in the intervention group, CGM data will be viewed real-time.
Device: Real-time CGM data
Experimental: Control
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Device: Real-time CGM data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL)
Time Frame: Up to 30 days
Percentage of time a person's blood glucose level stays within a specific range of 70-180 mg/dL
Up to 30 days
Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL)
Time Frame: Up to 30 days
Percentage of time a person's blood glucose level stays within a specific range on 70-200 mg/dL
Up to 30 days
Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL)
Time Frame: Up to 30 days
Percentage of time a person's blood glucose level stays within a specific range on 70-250 mg/dL
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Time in Hypoglycemia (<70 mg/dL)
Time Frame: Up to 30 days
Percentage of time a person's blood glucose level stays within a specific range < 70 mg/dL
Up to 30 days
Percentage Time in Hyperglycemia (>250 mg/dL)
Time Frame: Up to 30 days
Percentage of time a person's blood glucose level stays within a specific range > 250 mg/dL
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Whittier Diabetes Institute

Investigators

  • Principal Investigator: Athena Philis-Tsimikas, MD, Scripps Whittier Diabetes Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

March 17, 2020

Study Completion (Actual)

March 17, 2020

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

February 24, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-6878

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Real-time CGM data

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe