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

Diabetes Mellitus, Type 2 Clinical Trial

— Pilot Hosp CGM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068273
• Other study ID #: 15-6878
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 17, 2020

Study information

• Verified date: February 2022
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Device:
• Real-time CGM data

Locations

Country	Name	City	State
United States	Scripps Whittier Diabetes Institute	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target range (70-250 mg/dL): % days at target (type 1 diabetes)		through study completion, an average of 1 week
Primary	Target range (70-250 mg/dL): % days at target (type 2 diabetes)		through study completion, an average of 1 week
Primary	CGM patient acceptability questionnaire - patient-reported outcome		through study completion, an average of 1 week
Secondary	Hypoglycemia (<70 mg/dL): rate comparison (type 1 diabetes)		through study completion, an average of 1 week
Secondary	Hypoglycemia (<70 mg/dL): rate comparison (type 2 diabetes)		through study completion, an average of 1 week
Secondary	Hyperglycemia (>250 mg/dL): rate comparison (type 1 diabetes)		through study completion, an average of 1 week
Secondary	Hyperglycemia (>250 mg/dL): rate comparison (type 2 diabetes)		through study completion, an average of 1 week