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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Real-time CGM data


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>For type 2 patients in the intervention group, CGM data will be viewed real-time. | Device: Real-time CGM data<br> <br> |
| Experimental: Control<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target range (70-250 mg/dL): % days at target (type 1 diabetes) |  | through study completion, an average of 1 week | 
| Target range (70-250 mg/dL): % days at target (type 2 diabetes) |  | through study completion, an average of 1 week | 
| CGM patient acceptability questionnaire - patient-reported outcome |  | through study completion, an average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia (<70 mg/dL): rate comparison (type 1 diabetes) |  | through study completion, an average of 1 week | 
| Hypoglycemia (<70 mg/dL): rate comparison (type 2 diabetes) |  | through study completion, an average of 1 week | 
| Hyperglycemia (>250 mg/dL): rate comparison (type 1 diabetes) |  | through study completion, an average of 1 week | 
| Hyperglycemia (>250 mg/dL): rate comparison (type 2 diabetes) |  | through study completion, an average of 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospitalization