DM DEVICE DISRUPTION SURVEY

NCT05050019 | Unknown

• 1 other identifier: 202106074
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Continuous glucose monitoring (CGM) and insulin pump therapy (CSII) have increased in utilization in the treatment of both type 1 and type 2 diabetes mellitus. Both types of devices are worn externally, with either a catheter or filament introduced into the subcutaneous space. Removal of these devices interrupts glucose monitoring or insulin delivery or both, which may have an adverse impact on patients' glucose control. Few studies have investigated the logistical and technical challenges that patients face when their insulin pump device or continuous glucose monitor (CGM) is interrupted. Intervention: We will conduct a patient survey which seeks to identify and quantify the number of times insulin pump therapy or continuous glucose monitor has been disrupted, for what reason, how it was resolved and whether diabetes care had been adversely affected. Objective: To determine the frequency and intensity of adverse health outcomes resulting from mandatory removal of CGM on insulin pump devices in healthcare or other settings. Study population: Patients treated at Washington University outpatient clinics or Barnes Jewish Hospital between August 1, 2021- December 1, 2021. The study will include outpatients with diabetes mellitus who routinely utilize either CGM or insulin pump therapy or both. The target number of patients for the study will be 600, equally distributed between inpatients and outpatients, and with at least 100 having type 1 diabetes. Study methodology: After providing consent, patients will complete an electronic questionnaire. Demographic information and diabetes history will be extracted from the patients' medical records. Study endpoints: We will determine the incidence of disruptions to insulin pump therapy or continuous glucose monitoring in patients with diabetes mellitus as a result of hospitalization or medical test over a 1 year time period. We will also determine adverse health outcomes that resulted from device disruptions.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• the incidence of disruptions to insulin pump therapy or continuous glucose monitoring in patients with diabetes mellitus as a result of hospitalization or medical test

  Survey Responses

  over a 1 year time period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at Washington University outpatient clinics or Barnes Jewish Hospital between August 1, 2021- December 1, 2021. The study will include outpatients with diabetes mellitus who routinely utilize either CGM or insulin pump therapy or both. The target number of patients for the study will be 600, equally distributed between inpatients and outpatients, and with at least 100 having type 1 diabetes.

You may qualify if:

• Female and male patients 18 years or older who meet all of the following criteria:
• Patients treated at Washington University outpatient clinics or Barnes Jewish Hospital.
• Patients with type 1 or type 2 diabetes mellitus who utilize CGM and/or insulin pump therapy.
• Patients who were able to read English.

You may not qualify if:

• Patients who have not used a relevant device in the past 30 days
• Patients unwilling to or unable to provide consent or complete the questionnaire.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University, Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Andrea Cedeno, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: October 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

US (1)