DexCom Hospital Study-CGM Directed Insulin Delivery

NCT05504785 | Terminated FDA Device

• 1 other identifier: 12039
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot investigator initiated/sponsored clinical trial to evaluate the feasibility of using real-time DexCom G6 continuous glucose monitor (CGM or glucose sensor) trend data and an insulin-dosing algorithm to control the glucose levels of type 2 diabetic patients undergoing hip/knee orthopedic surgery at Thomas Jefferson University Hospital (TJUH). Blinded CGM glucose data will be recorded prior to hospital admission, during hospital admission, and after hospital discharge to evaluate glucose control in this diabetic patient population in relationship to clinical outcomes (20 days of recorded blinded CGM data maximum). Prior studies have associated hyperglycemia, hypoglycemia, and glycemic variability with an increased incidence of nosocomial infection, deep vein thrombosis, pulmonary embolism, cardiac arrhythmias, mental status changes, hospital length of stay, and cost. The 20 type 2 diabetic patients in the Control Group will be managed according to standard-of-care methods at TJUH using finger-stick blood glucose measurements in an attempt to maintain the patient's blood glucose levels in the desired target range (80 to 180 mg/dL). Three blinded CGM will be used to record the patient's glucose trend data for future download to a computer and analysis. The 40 type 2 diabetic patients in the Investigational Group will be managed by the orthopedic floor nurses using the real-time DexCom G6 CGM trend data to determine the appropriate therapy to maintain the patient's glucose levels in the desired target range (80 to 180 mg/dL). In addition, three blinded CGM will be used to record the patient's glucose trend data for future download to a computer and analysis. The primary objective of this pilot study is to observe the blood glucose values and glucose sensor (CGM) values of diabetic patients before, during and after hospitalization for hip and knee arthroplasty surgery to determine whether there is a correlation between glucose control and clinical outcomes. This pilot data will be used to plan a future clinical trial in orthopedic surgery patients using CGM to determine patterns of hyperglycemia, hypoglycemia, and glycemic variability that correlate with clinical complications, hospital length of stay, and cost.

Conditions

Type 2 Diabetes; Hip Osteoarthritis; Knee Osteoarthritis

Keywords

Type 2 diabetes; joint replacement surgery; Insulin dose protocol; Real-time Continuous Glucose Monitor (CGM)

Outcome Measures

Primary Outcomes (1)

• Observe correlation of glucose control and post-operative adverse clinical events

  Observe blood glucose values and continuous glucose monitor (CGM or glucose sensor) values of diabetic patients before, during and after hospitalization for joint arthroplasty surgery to determine whether there is a correlation between glucose control and clinical outcomes. CGM data (mg/dL, mean, median, standard deviation, percent of 24 hours within the target range (80-180 mg/dL), above the target range (180-240 mg/dL and \> 240 mg/dL), and below the target range (\< 70 mg/dL, 40-70 mg/dL, \< 40 mg/dL) will be correlated with the incidence of wound infection, deep vein thrombosis, pulmonary embolism, extended hospital length of stay, hospital re-admission, and post-op emergency room visits. Finger-stick blood glucose measurements will also be correlated with adverse clinical outcomes.

  perioperative period x 60 days

Secondary Outcomes (2)

• Hospital nurses and physicians provide subjective feedback regarding the ease-of-use and human-factors issues following clinical use of the real-time CGM trend data

  perioperative period x 1 to 3 days

• Compare the CGM and Accu-Chek time-match glucose measurements

  perioperative x 1 to 3 days

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Twenty type 2 diabetic patients in the Control Group will be managed according to standard-of-care methods at TJUH using finger-stick blood glucose measurements in an attempt to maintain the patient's blood glucose levels in the desired target range (80 to 180 mg/dL). Three blinded CGM will be used to record the patient's glucose trend data (for 20 days maximum) for future download to a computer and analysis.

Device: DexCom G6 continuous glucose monitor

Investigational Group

ACTIVE COMPARATOR

Forty type 2 diabetic patients in the Investigational Group will be managed by the orthopedic floor nurses using the real-time DexCom G6 CGM trend data to determine the appropriate therapy to maintain the patient's glucose levels in the desired target range (80 to 180 mg/dL). In addition, three blinded CGM will be used to record the patient's glucose trend data (for 20 days maximum) for future download to a computer and analysis.

Device: DexCom G6 continuous glucose monitor

Interventions

DexCom G6 continuous glucose monitor DEVICE

Use of real-time DexCom G6 continuous glucose monitor (CGM or glucose sensor) trend data and an insulin-dosing algorithm to control the glucose levels of diabetic patients undergoing hip/knee orthopedic surgery at Thomas Jefferson University Hospital (TJUH).

Control Group; Investigational Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All type 2 diabetic patients undergoing a single surgical hip or knee replacement at Thomas Jefferson University Hospital (TJUH); on an outpatient regimen of oral antidiabetic medication, injectable antidiabetic medication, basal-bolus insulin therapy, or premix insulin therapy.
• Age 30 to 80 years
• BMI ≤ 40

You may not qualify if:

• BMI \> 40.
• Age \< 30 years or \> 80 years
• History of two of more hypoglycemia episodes in last 12 months.
• History of severe hypoglycemia unawareness.
• History of diabetic ketoacidosis (DKA) in the last 6 months.
• History of significant skin/tissue reaction (irritation or allergy) to the Continuous Glucose Monitor's (CGM) adhesive tape, plastic bandage, or chlorhexidine.
• Skin infection or disease at the site of CGM insertion.
• Moderate or severe systemic immune deficiency (previous 90 days).
• Currently enrolled in any industry sponsored medical device or pharmaceutical research clinical trial.
• Treated with high-dose anticoagulation therapy at the time of CGM insertion.
• Double or revision knee/hip replacement surgery.
• Anticipate an MRI is required during the hospitalization.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jeffrey I Joseph, DO

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twenty type 2 diabetic patients in the Control Group will be managed according to standard-of-care methods at TJUH using finger-stick blood glucose measurements in an attempt to maintain the patient's blood glucose levels in the desired target range (80 to 180 mg/dL). Forty type 2 diabetic patients in the Investigational Group will be managed by the orthopedic floor nurses using the real-time DexCom G6 CGM trend data and an insulin dosing protocol to determine the appropriate therapy to maintain the patient's glucose levels in the desired target range (80 to 180 mg/dL). T Glucose control will be compared between the two groups, and glucose control will be correlated with post-operative clinical adverse events (wound infection, deep vein thrombosis, pulmonary embolism, extended hospital LOS, hospital re-admission, emergency room visit).

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: August 17, 2022
• Study Start: August 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)