Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign (Pilot Hosp CGM)
Primary Purpose
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real-time CGM data
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring Hospitalization
Eligibility Criteria
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).
Sites / Locations
- Scripps Whittier Diabetes Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention
Control
Arm Description
For type 2 patients in the intervention group, CGM data will be viewed real-time.
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Outcomes
Primary Outcome Measures
Target range (70-250 mg/dL): % days at target (type 1 diabetes)
Target range (70-250 mg/dL): % days at target (type 2 diabetes)
CGM patient acceptability questionnaire - patient-reported outcome
Secondary Outcome Measures
Hypoglycemia (<70 mg/dL): rate comparison (type 1 diabetes)
Hypoglycemia (<70 mg/dL): rate comparison (type 2 diabetes)
Hyperglycemia (>250 mg/dL): rate comparison (type 1 diabetes)
Hyperglycemia (>250 mg/dL): rate comparison (type 2 diabetes)
Full Information
NCT ID
NCT03068273
First Posted
October 12, 2016
Last Updated
February 4, 2022
Sponsor
Scripps Whittier Diabetes Institute
1. Study Identification
Unique Protocol Identification Number
NCT03068273
Brief Title
Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
Acronym
Pilot Hosp CGM
Official Title
Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Whittier Diabetes Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
Hospitalization
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
For type 2 patients in the intervention group, CGM data will be viewed real-time.
Arm Title
Control
Arm Type
Experimental
Arm Description
For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.
Intervention Type
Device
Intervention Name(s)
Real-time CGM data
Primary Outcome Measure Information:
Title
Target range (70-250 mg/dL): % days at target (type 1 diabetes)
Time Frame
through study completion, an average of 1 week
Title
Target range (70-250 mg/dL): % days at target (type 2 diabetes)
Time Frame
through study completion, an average of 1 week
Title
CGM patient acceptability questionnaire - patient-reported outcome
Time Frame
through study completion, an average of 1 week
Secondary Outcome Measure Information:
Title
Hypoglycemia (<70 mg/dL): rate comparison (type 1 diabetes)
Time Frame
through study completion, an average of 1 week
Title
Hypoglycemia (<70 mg/dL): rate comparison (type 2 diabetes)
Time Frame
through study completion, an average of 1 week
Title
Hyperglycemia (>250 mg/dL): rate comparison (type 1 diabetes)
Time Frame
through study completion, an average of 1 week
Title
Hyperglycemia (>250 mg/dL): rate comparison (type 2 diabetes)
Time Frame
through study completion, an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athena Philis-Tsimikas, MD
Organizational Affiliation
Scripps Whittier Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Whittier Diabetes Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32855160
Citation
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.
Results Reference
derived
Learn more about this trial
Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
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