NCT03068273

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

October 15, 2025

Completed
Last Updated

October 15, 2025

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

October 12, 2016

Results QC Date

July 28, 2025

Last Update Submit

September 26, 2025

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Keywords

Hospitalization

Outcome Measures

Primary Outcomes (3)

  • Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL)

    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)

    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)

    Percentage of time a person's blood glucose level stays within a specific range on 70-250 mg/dL

    Up to 30 days

Secondary Outcomes (2)

  • Percentage Time in Hypoglycemia (<70 mg/dL)

    Up to 30 days

  • Percentage Time in Hyperglycemia (>250 mg/dL)

    Up to 30 days

Study Arms (2)

Intervention

EXPERIMENTAL

For type 2 patients in the intervention group, CGM data will be viewed real-time.

Device: Real-time CGM data

Control

EXPERIMENTAL

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

Interventions

Real-time CGM dataDEVICE
ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

Related Publications (1)

  • Fortmann AL, Spierling Bagsic SR, Talavera L, Garcia IM, Sandoval H, Hottinger A, Philis-Tsimikas A. Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting. Diabetes Care. 2020 Nov;43(11):2873-2877. doi: 10.2337/dc20-1016. Epub 2020 Aug 27.

    PMID: 32855160DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

The control group was not considered ethical for the T1D arm; therefore, no comparison data was available.

Results Point of Contact

Title
Athena Philis-Tsimikas
Organization
Scripps Health
philis-tsimikas.athena@scrippshealth.org
858-678-7077

Study Officials

  • Athena Philis-Tsimikas, MD

    Scripps Whittier Diabetes Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Corporate Vice President

Study Record Dates

First Submitted

October 12, 2016

First Posted

March 1, 2017

Study Start

May 1, 2015

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

October 15, 2025

Results First Posted

October 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)