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OpenTrials
Completed

NCT Number: NCT03068273

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Expected length of hospital stay of at least 48 hours
  • One of the following:
  • Diagnosed with diabetes type 1 OR
  • 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).

Treatment and study plan

Real-time CGM data

Device

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Scripps Whittier Diabetes Institute

Other

Registry information

Acronym: CGM

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 1, 2017
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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