Clinical trial NCT03792399: Continuous Glucose Monitoring With Immediate or Delayed Counseling Feedback
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: continuous glucose monitoring
immediate feedback counseling
delayed feedback counseling
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 45 years old or more at recent outpatient visits;
* Type 2 diabetic patients followed up at National Cheng Kung University Hospital;
* Patients planned to receive CGM suggested by primary care physician due to inadequate controlled blood glucose.

Exclusion Criteria:

* Patients with diagnosis of generalized inflammation, advanced malignancy, end-stage renal disease on regular dialysis, status post renal transplantation, end-stage liver, heart or pulmonary disease;
* Patients who are taking systemic glucocorticoids;
* Any acute or chronic inflammatory disease as determined by a leukocyte count over 10,000/mm3 or clinical signs of infection;
* Patients who could not complete the questionnaires or who could not follow order due to cognitive impairment or in bed-ridden status;
* Patients diagnosed as thalassemia, glucose-6-phosphate dehydrogenase deficiency, and any other hemoglobinopathies that may influence the accuracy of hemoglobulin A1c measurement were also excluded. Patients who received blood transfusion in recent 3 months were also excluded.

Primary outcomes:
measure: Change of HbA1c
timeFrame: Baseline and 3 months after CGM counseling
measure: Change of score for self efficacy
timeFrame: Baseline and 3 months after CGM counseling
Secondary outcomes:
measure: Change of score for diabetes associated stress
timeFrame: Baseline and 3 months after CGM counseling
measure: Change of score for depression
timeFrame: Baseline and 3 months after CGM counseling
measure: Change in diet composition
timeFrame: Baseline and 3 months after CGM counseling
measure: Change in exercise amount, time spent in light activity
timeFrame: Baseline and 3 months after CGM counseling
measure: Change in exercise amount, time spent in moderate activity
timeFrame: Baseline and 3 months after CGM counseling
measure: Change in exercise amount, time spent in intense activity
timeFrame: Baseline and 3 months after CGM counseling
measure: Change in exercise amount (time spent in sedentary behavior)
timeFrame: Baseline and 3 months after CGM counseling
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Gerontology, NCKU
name: Ching-Ju Chiu, Ph.D.
role: STUDY_DIRECTOR
affiliation: NCKUH
name: Ye-Fong Du, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen NA, Fain JA, Braun B, Chipkin SR. Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial. Diabetes Res Clin Pract. 2008 Jun;80(3):371-9. doi: 10.1016/j.diabres.2008.01.006. Epub 2008 Mar 4.