Continuous Glucose Monitoring of Hospitalized Patients With Diabetes

Sponsor
Baylor Research Institute (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04230694
Collaborator
(none)
40
1
2
6.3
6.3

Study Details

Study Description

Brief Summary

Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been found to be helpful for reducing hypoglycemia in some studies while less so in others, however, these studies were performed with earlier generation glucose monitoring devices(5). ICU studies have confirmed accuracy of CGM measurements compared with capillary glucose even in settings with use of vasopressors and large-volume resuscitation. A limited number of studies have evaluated glycemic outcomes in the inpatient non-ICU setting. Studies of non-ICU patients (6-10) are limited by very small sample size, short study duration, and use of older CGM devices. There is, therefore, a critical need to systematically investigate the use of CGM in the inpatient care of patients with diabetes mellitus who are receiving care in a hospital setting that is typical of inpatient care.

Condition or Disease Intervention/Treatment Phase
  • Device: Dexcom Generation 6 CGM (Dexcom Gen6) device
N/A

Detailed Description

AIM

  1. Test the health impact of CGM of inpatients as defined by rates of hypo- and hyperglycemia and the derivative of time in appropriate glucose range. Forty (40) patients will be randomized 1:1 into one of two conditions. In the treatment condition, patients will receive a Dexcom Gen6 device and the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will be trained to use readings from the Dexcom Gen6 for the management of the patient's glucose levels below 100. In the control condition, patients will receive a Dexcom Gen6 device, but the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will not have access to the readings and will provide usual care (four glucose checks per 24 hours and use of insulin or other diabetic agent ordered by the admitting and rounding providers to determine glucose management).
  1. Hypothesis 1: Patients in the treatment condition will experience fewer episodes of hypoglycemia as compared to patients in the control condition as measured by the Dexcom Gen6 readings.

  2. Hypothesis 2: Patients in the treatment condition will experience less frequent hyperglycemia events as compared to patients in the control condition as measured by the Dexcom Gen6 readings.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Dexcom Generation 6 CGM (Dexcom Gen6) deviceDexcom Generation 6 CGM (Dexcom Gen6) device
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes: A Pilot Study to Establish Evidence
Actual Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

Control Group subjects will wear the CGM device during their hospitalization, up to 14 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay.

Device: Dexcom Generation 6 CGM (Dexcom Gen6) device
Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings.
Other Names:
  • CGM
  • Experimental: Treatment Group

    Treatment Group subjects will wear the CGM device during their hospitalization, up to 14 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks.

    Device: Dexcom Generation 6 CGM (Dexcom Gen6) device
    Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings.
    Other Names:
  • CGM
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Hypoglycemia Events during hospitalization [Up to 14 days]

      Dexcom Gen6 readings

    Secondary Outcome Measures

    1. Number of Hyperglycemia Events during hospitalization [Up to 14 days]

      Dexcom Gen6 readings

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with Type 1 and Type 2 diabetes.

    • Subjects greater than 18 years of age with diabetes.

    • Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day)

    • Subjects with expected hospital length-of-stay of 2 or more days.

    • Subjects willing to wear CGM device.

    Exclusion Criteria:
    • Female subjects who are pregnant or lactating at the time of enrollment into the study. Females with child bearing potential will be queried about the possibility of pregnancy and a serum pregnancy test will be performed.

    • Subjects with greater than 4gm use of Tylenol/24 hr.

    • Surgical patients or patients with pre-planned surgery during the study.

    • Subjects with acute illness admitted to the ICU or expected to require admission to the ICU.

    • Patients who may potentially require IV insulin.

    • Patients with a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding. (Coagulation disorder, treatment with anticoagulants (Coumadin and Novel Oral Anticoagulants "NOACs" at home), or platelet count < 50,000).

    • Patients with skin lesions, severe psoriasis, burns, tattoos, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.

    • Patient with a known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.

    • Patients receiving glucocorticosteroids in doses equivalent to ≥ 20 mg of hydrocortisone/day or immunosuppressed patients which prevent wound healing.

    • Patients who have had organ transplant.

    • Hematocrit outside specification of the study-assigned blood glucose meter (hematocrit ≤ 30% or ≥ 55%).

    • Patients with any severe medical conditions such as end-stage renal disease on dialysis, status post renal transplantation, end-stage liver disease with diffuse anasarca, heart failure on inotropic support, Ejection Fraction (EF) < 15 % or pulmonary disease requiring NIPPV or severe sepsis.

    • Any condition for which, in the opinion of the investigators, it would not be in the best interest of the participant.

    • Legally protected subjects (under judicial protection, guardianship, or supervision), persons deprived of their liberty, mental or language barriers rendering the subject unable to understand the nature, scope and possible consequences of the study.

    • Subjects with active substance abuse.

    • Subjects with infaust prognosis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baylor Scott & White Medical Center - Temple Temple Texas United States 76508

    Sponsors and Collaborators

    • Baylor Research Institute

    Investigators

    • Principal Investigator: Tresa McNeal, MD, Baylor Scott & White Medical Center - Temple

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Baylor Research Institute
    ClinicalTrials.gov Identifier:
    NCT04230694
    Other Study ID Numbers:
    • 018-601
    First Posted:
    Jan 18, 2020
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Baylor Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2021