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Continuous Glucose Monitoring With Immediate or Delayed Counseling Feedback

1. Januar 2019 aktualisiert von: National Cheng-Kung University Hospital

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

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

20

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

45 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Sonstiges: 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).
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change of HbA1c
Zeitfenster: Baseline and 3 months after CGM counseling
Change of HbA1c in 3 months after CGM counseling.
Baseline and 3 months after CGM counseling
Change of score for self efficacy
Zeitfenster: 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.
Baseline and 3 months after CGM counseling

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change of score for diabetes associated stress
Zeitfenster: 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.
Baseline and 3 months after CGM counseling
Change of score for depression
Zeitfenster: 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).
Baseline and 3 months after CGM counseling
Change in diet composition
Zeitfenster: Baseline and 3 months after CGM counseling
Change of carbohydrate amounts, fruits amount in 3 months after CGM counseling.
Baseline and 3 months after CGM counseling
Change in exercise amount, time spent in light activity
Zeitfenster: 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.
Baseline and 3 months after CGM counseling
Change in exercise amount, time spent in moderate activity
Zeitfenster: 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.
Baseline and 3 months after CGM counseling
Change in exercise amount, time spent in intense activity
Zeitfenster: 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.
Baseline and 3 months after CGM counseling
Change in exercise amount (time spent in sedentary behavior)
Zeitfenster: 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.
Baseline and 3 months after CGM counseling

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Cheng-Kung University Hospital

Ermittler

  • Studienleiter: Ching-Ju Chiu, Ph.D., Institute of Gerontology, NCKU
  • Hauptermittler: Ye-Fong Du, M.D., NCKUH

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. März 2016

Primärer Abschluss (Tatsächlich)

12. Oktober 2017

Studienabschluss (Tatsächlich)

12. Oktober 2017

Studienanmeldedaten

Zuerst eingereicht

8. November 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Januar 2019

Zuerst gepostet (Tatsächlich)

3. Januar 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Januar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Januar 2019

Zuletzt verifiziert

1. November 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • NCKUH-10508011

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

The study protocol will be shared after study publication.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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