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Continuous Glucose Monitoring With Immediate or Delayed Counseling Feedback

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03792399
Recruitment Status : Completed
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: feedback counseling Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : March 7, 2016
Actual Primary Completion Date : October 12, 2017
Actual Study Completion Date : October 12, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Immediate feedback counseling
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
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 counseling
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change of HbA1c [ Time Frame: Baseline and 3 months after CGM counseling ]
    Change of HbA1c in 3 months after CGM counseling.

  2. Change of score for self efficacy [ Time Frame: Baseline and 3 months after CGM counseling ]
    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.


Secondary Outcome Measures :
  1. Change of score for diabetes associated stress [ Time Frame: Baseline and 3 months after CGM counseling ]
    Change of score for Problem Areas in Diabetes Scale (PAID) in 3 months after CGM counseling. PAID is a 20-item self-reported questionnaire with scale 0-4 for each question, generating a total score of 0-100. A score of ≥ 40 is defined as emotional burnout.

  2. Change of score for depression [ Time Frame: Baseline and 3 months after CGM counseling ]
    Change of score for Center for Epidemiologic Studies Depression Scale Revised (CESD-R) in 3 months after CGM counseling. With 10-ietm CESD-R scale scoring 10 or more defined as having depression (range 0 to 30).

  3. Change in diet composition [ Time Frame: Baseline and 3 months after CGM counseling ]
    Change of carbohydrate amounts, fruits amount in 3 months after CGM counseling.

  4. Change in exercise amount, time spent in light activity [ Time Frame: Baseline and 3 months after CGM counseling ]
    Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in light activity per day in 3 months after CGM counseling feedback is compared with baseline.

  5. Change in exercise amount, time spent in moderate activity [ Time Frame: Baseline and 3 months after CGM counseling ]
    Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in moderate activity per day in 3 months after CGM counseling feedback is compared with baseline.

  6. Change in exercise amount, time spent in intense activity [ Time Frame: Baseline and 3 months after CGM counseling ]
    Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in intense activity per day in 3 months after CGM counseling feedback is compared with baseline.

  7. Change in exercise amount (time spent in sedentary behavior) [ Time Frame: Baseline and 3 months after CGM counseling ]
    Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in sedentary behavior in 3 months after CGM counseling feedback is compared with baseline.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792399


Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
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Study Director: Ching-Ju Chiu, Ph.D. Institute of Gerontology, NCKU
Principal Investigator: Ye-Fong Du, M.D. NCKUH
More Information
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Publications:

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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03792399    
Other Study ID Numbers: NCKUH-10508011
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study protocol will be shared after study publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cheng-Kung University Hospital:
continuous glucose monitoring
immediate feedback counseling
delayed feedback counseling