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

• Sponsor: Scripps Whittier Diabetes Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03068273
• Collaborator: (none)
• Enrollment: 310
• Location: 1
• Arms: 2
• Actual Duration (Months): 58.5
• Patients Per Site Per Month: 5.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2	Device: Real-time CGM data	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 310 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Mar 17, 2020
• Actual Study Completion Date: Mar 17, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Target range (70-250 mg/dL): % days at target (type 1 diabetes) [through study completion, an average of 1 week]

2. Target range (70-250 mg/dL): % days at target (type 2 diabetes) [through study completion, an average of 1 week]

3. CGM patient acceptability questionnaire - patient-reported outcome [through study completion, an average of 1 week]

Secondary Outcome Measures

1. Hypoglycemia (<70 mg/dL): rate comparison (type 1 diabetes) [through study completion, an average of 1 week]

2. Hypoglycemia (<70 mg/dL): rate comparison (type 2 diabetes) [through study completion, an average of 1 week]

3. Hyperglycemia (>250 mg/dL): rate comparison (type 1 diabetes) [through study completion, an average of 1 week]

4. Hyperglycemia (>250 mg/dL): rate comparison (type 2 diabetes) [through study completion, an average of 1 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Whittier Diabetes Institute	La Jolla	California	United States	92037

Sponsors and Collaborators

• Scripps Whittier Diabetes Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Athena Philis-Tsimikas, Corporate Vice President, Scripps Whittier Diabetes Institute
• ClinicalTrials.gov Identifier: NCT03068273
• Other Study ID Numbers: 15-6878
• First Posted: Mar 1, 2017
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Athena Philis-Tsimikas, Corporate Vice President, Scripps Whittier Diabetes Institute: Hospitalization
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Feb 8, 2022