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N/A N=157 Randomized Single-blind Other

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

Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2

Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL) — 25.31; 19.89; 26.04 percentage of time during CGM use — p=0.1460

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Real-time CGM data (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Scripps Whittier Diabetes Institute
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL)
25.31; 19.89; 26.04 0.1460
PRIMARY
Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL)
42.82; 33.38; 33.57 0.0615
PRIMARY
Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL)
72.83; 63.95; 65.97 0.0404 sig
SECONDARY
Percentage Time in Hypoglycemia (<70 mg/dL)
0; 0; 0 0.2680
SECONDARY
Percentage Time in Hyperglycemia (>250 mg/dL)
27.00; 32.96; 34.04 0.0403 sig

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.

Eligibility Criteria

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03068273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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