Feasibility and Performance of Continuous Glucose Monitoring to Guide Computerized Insulin Infusion Therapy in Non-ICU Patients Receiving Corticosteroid Therapy and Specialized Nutrition

ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

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 receiving IV insulin therapy, and (2) assessing both nursing acceptance/convenience and patient satisfaction with CGM use. A randomized prospective trial model will be used comparing glucose control (glucometrics hypoglycemia), patient experience and nursing satisfaction in cancer patients receiving IV insulin therapy where monitoring is done via: a) hybrid protocol originally developed by Faulds et al. integrating CGM with periodic POC-BG tests to monitor and ensure the ongoing accuracy of CGM measurements (available at http://www.covidindiabetes.org). b) standard care with hourly POC testing and blinded professional CGM.Inclusion criteria: Eligible patients include oncology and post-transplant patients receiving IV insulin therapy while on corticosteroid treatment and receiving specialized nutrition. Exclusion criteria: medically instable patients receiving pressor therapy and ICU level of care. Outcome evaluation; Patients' characteristics were collected through the EHR. Glucometrics will be collected throughout the study to include mean BS, % in range ( 80-180) , patient day hypoglycemia , patient stay hypoglycemia . Nursing surveys: Survey will be provided for nurses to assess nursing burden, acceptability. Nurses will complete a survey before starting the project and again after being involved in the initial and ongoing validation phases of CGM at the end of the project. The purpose is to report their convenience with using CGM and their preferred glucose monitoring method, which included POC arterial blood, POC finger sticks, and CGM. Nursing surveys will be administrated electronically to nursing staff and the results will be uploaded automatically. Patient survey: Patients will be approached by the team members to inquire about the willingness to provide feedback. The questionnaire will assess their experiences of care with CGM (options: very good, good, fair, poor), glucose check without pain and disruptions of sleep (yes/no), and overall confidence of care with CGM process (very confident, quite confident, somewhat confident, little confident). Patient surveys will handed out by the team members, and the results were subsequently entered into database (See both nursing and patient surveys in Supplementary Material.)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexcom G7 CGM

    Other intervention

    The Dexcom G7 is a continuous glucose monitor, FDA 510K cleared (K213919) for people with diabetes. Worn for 10 days at a time, the device monitors the glucose levels of interstitial fluid and, via bluetooth, transmits data every 5 minutes to a receiver.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Unblinded CGMOther 1 intervention
Group B: Blinded CGMOther 1 intervention

Trial outcomes

Primary outcomes

1

Non-inferiority for TIR (Time in Range)

Participant characteristics will be collected through the EHR. Descriptive analyses will be conducted to summarize patient characteristics, POC-BG, CGM data and survey data.

Time frame
12 Months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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