Clinical Trials Directory

Trials / Completed

CompletedNCT03792399

Continuous Glucose Monitoring With Immediate or Delayed Counseling Feedback

Impact of Innovative Technology on Geriatric Diabetic Patients: Evaluation of Quality of Life, Self Efficacy and Glycemic Control Among Patients With Experience of Continuous Glucose Monitoring

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
National Cheng-Kung University Hospital · Academic / Other
Sex
All
Age
45 Years
Healthy volunteers
Not accepted

Summary

This study is designed to explore the effect of feedback counseling using professional continuous glucose monitoring on glycemic control, self-efficacy, and self-management behaviors among middle aged and older adults with poor controlled type 2 diabetes mellitus. This study also explores the difference on timing of feedback after continuous glucose monitoring exam.

Detailed description

After scheduled routine professional continuous glucose monitoring (CGM) exam, participants in both the intervention and control group receive ordinary education and regimen adjustment as indicated based on CGM results. For participants in the intervention group, they will also receive CGM counseling immediately on the day of CGM sensor removal. For participants in the control group, they will receive CGM counseling on the day of routine 3 months outpatient visit. Qualitative data are collected through in-depth interview: User expectation, acceptability and satisfaction of CGM are also explored during in-depth interview with a semi-structured questionnaire. Quantitative data were collected through validated questionnaires, including evaluation of depression by a short form of the Center for Epidemiologic Studies Depression Scale Revised (CES-D-R), emotional stress by Problem Areas in Diabetes Scale (PAID), self efficacy by Stanford Self-Efficacy for Diabetes (SES), at pretest and 3 months after CGM counseling. Anthropometric Measurements. Body height, body weight, body mass index, and blood pressure were recorded at pre-test and post-test interview. Blood Tests. Routine biochemistry, fasting plasma glucose, hemoglobin A1c (HbA1c) are collected within 2 weeks of pretest and posttest day.

Conditions

Interventions

TypeNameDescription
BEHAVIORALfeedback counselingProfessoinal CGM in combination with diet and exercise record is used as teaching material to help patient realize their blood glucose pattern and to modify their behavior after counseling feedback.

Timeline

Start date
2016-03-07
Primary completion
2017-10-12
Completion
2017-10-12
First posted
2019-01-03
Last updated
2019-01-03

Source: ClinicalTrials.gov record NCT03792399. Inclusion in this directory is not an endorsement.