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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2020-03-17

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.

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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.

Conditions

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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Real-time CGM data

Intervention Type DEVICE

Control

For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group.

Group Type EXPERIMENTAL

Real-time CGM data

Intervention Type DEVICE

Interventions

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Real-time CGM data

Intervention Type DEVICE

Eligibility Criteria

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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

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No