NCT03792399

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
Last Updated

January 3, 2019

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

November 8, 2018

Last Update Submit

January 1, 2019

Conditions

Type2 Diabetes

Keywords

continuous glucose monitoringimmediate feedback counselingdelayed feedback counseling

Outcome Measures

Primary Outcomes (2)

  • Change of HbA1c

    Change of HbA1c in 3 months after CGM counseling.

    Baseline and 3 months after CGM counseling

  • Change of score for self efficacy

    Change of Stanford Self-Efficacy for Diabetes Scale (SES) in 3 months after CGM counseling. The score for each item ranged from 1-10. The score of the scale is the mean of the eight items. Higher number indicated higher self-efficacy.

    Baseline and 3 months after CGM counseling

Secondary Outcomes (7)

  • Change of score for diabetes associated stress

    Baseline and 3 months after CGM counseling

  • Change of score for depression

    Baseline and 3 months after CGM counseling

  • Change in diet composition

    Baseline and 3 months after CGM counseling

  • Change in exercise amount, time spent in light activity

    Baseline and 3 months after CGM counseling

  • Change in exercise amount, time spent in moderate activity

    Baseline and 3 months after CGM counseling

  • +2 more secondary outcomes

Study Arms (2)

Immediate feedback counseling

EXPERIMENTAL

Professional CGM calibrate blood glucose via a glucsoe-oxidase-impregnated membrane during a 5 day period. The patient wearing professional CGM is randomized to immediate feedback after data downloaded into computer.

Behavioral: feedback counseling

Delayed feedback counseling

OTHER

Professional CGM calibrate blood glucose via a glucsoe-oxidase-impregnated membrane during a 5 day period. The patient wearing professional CGM is randomized to delayed feedback (standard care, i.e., CGM graphs interpretation at scheduled 3 months outpatient visit).

Behavioral: feedback counseling

Interventions

feedback counselingBEHAVIORAL

Professoinal 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.

Delayed feedback counselingImmediate feedback counseling

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18304674BACKGROUND

Study Officials

  • Ching-Ju Chiu, Ph.D.

    Institute of Gerontology, NCKU

    STUDY DIRECTOR

  • Ye-Fong Du, M.D.

    NCKUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

January 3, 2019

Study Start

March 7, 2016

Primary Completion

October 12, 2017

Study Completion

October 12, 2017

Last Updated

January 3, 2019

Record last verified: 2018-11