Clinical trial NCT03068273: Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
Official title: Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: Hospitalization
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Target range (70-250 mg/dL): % days at target (type 1 diabetes)
timeFrame: through study completion, an average of 1 week
measure: Target range (70-250 mg/dL): % days at target (type 2 diabetes)
timeFrame: through study completion, an average of 1 week
measure: CGM patient acceptability questionnaire - patient-reported outcome
timeFrame: through study completion, an average of 1 week
Secondary outcomes:
measure: Hypoglycemia (<70 mg/dL): rate comparison (type 1 diabetes)
timeFrame: through study completion, an average of 1 week
measure: Hypoglycemia (<70 mg/dL): rate comparison (type 2 diabetes)
timeFrame: through study completion, an average of 1 week
measure: Hyperglycemia (>250 mg/dL): rate comparison (type 1 diabetes)
timeFrame: through study completion, an average of 1 week
measure: Hyperglycemia (>250 mg/dL): rate comparison (type 2 diabetes)
timeFrame: through study completion, an average of 1 week
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.