DM DEVICE DISRUPTION SURVEY

Diabetes Mellitus Clinical Trial

Official title:

DIABETES DEVICE DISRUPTION DUE TO HOSPITALIZATIONS AND RADIOLOGIC PROCEDURES

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05050019
• Other study ID #: 202106074
• Status: Enrolling by invitation
• Start date: October 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

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.

Exclusion Criteria

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
United States	Washington University, Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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