Status:
NOT_YET_RECRUITING
Feasibility and Performance of Continuous Glucose Monitoring to Guide Computerized Insulin Infusion Therapy in Non-ICU Patients Receiving Corticosteroid Therapy and Specialized Nutrition
Lead Sponsor:
University of Nebraska
Conditions:
Diabetes
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The objective of this pilot study is to assess the feasibility and performance of real-time CGM for titrating CII via: (1) evaluation of CGM glucose accuracy in oncology and post-transplant population...
Detailed Description
The objective of this pilot study is to assess the feasibility and performance of real-time CGM for titrating Continuous Insulin Infusion Therapy (CII) via: (1) evaluation of CGM glucose accuracy in o...
Eligibility Criteria
Inclusion
- Age \>19 years old
- Patients with diabetes or stress induced hyperglycemia requiring continuous insulin infusion therapy, with anticipated duration of this therapy being \> 24 hours. Specifically, we will include
- Patients with Type 2 diabetes; or if not previously diagnosed as having diabetes, HbA1c \>7.0% (laboratory-measured at or since hospital admission or within prior 3-months).
- Type 1 diabetes, as well as atypical forms of diabetes (including pancreatectomy and pancreatitis) and
- Stress hyperglycemia defined as at least 1 blood glucose measurement \>180 mg/dL since admission in a patient without history of diabetes, if CII is indicated per treating physician
- Insulin drip (CII) already initiated since admission or planned to be initiated
- Non-critical hospitalization with expected duration of CII \> 24 hours at time of randomization
- Oncology and post-transplant population receiving IV insulin therapy
Exclusion
- Inability to provide written consent
- Medically unstable patients receiving pressor therapy and ICU level of care.
- Patients transferred from ICU with an expected requirement for CII \> 24 hours on a non-ICU floor are eligible)
- For women of childbearing potential: currently pregnant or breastfeeding
- Hypoxia (O2 saturation \< 90 %) present at time of potential enrollment
- Hemoglobin \< 7 mg/dL;
- Anasarca present at time of potential enrollment
- Use of hydroxyurea or high dose acetaminophen use of \>4g daily as those are substances known to interfere with CGM system.
- eGFR \< 20 mL/min or dialysis being received or planned
- Known allergy to medical grade adhesives or a skin condition that may impact CGM performance per investigator discretion
- Admission for Diabetic ketoacidosis or hyperosmolar hyperglycemic state
- Nurse Participants:
- Adults aged 19 and older involved in the routine care of the patient participants
- Adequate proficiency to understand and provide informed consent in English
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07194642
Start Date
September 30 2025
End Date
November 30 2026
Last Update
October 1 2025
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