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L'essai clinique NCT04306848 pour Blood Glucose Profile est retiré. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education Mode de vie
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L'essai clinique NCT04306848 est une étude interventionnel pour Blood Glucose Profile. Son statut actuel est : retiré. L'étude a débuté le 1 janvier 2021 et vise à recruter N/A participants. Dirigée par l'Université de l'Ohio, l'étude devrait être terminée d'ici le 1 mars 2022. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 25 mars 2022.
Résumé succinct
This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in a lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD).
Description détaillée
Glucose peaks after eating are an indication of the level of insulin resistance and the severity of disease in patients with T2DM. Many lifestyle factors affect the glucose elevation, including the glycemic index of food, timing of eating, physical activity, stress and sleep.
In practice, a glycemic profile, consisting of multiple glucose measurements before and after meals throughout the day, has sometimes been hel...
Afficher plusTitre officiel
Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education for People With Type 2 Diabetes: a Feasibility Study.
Pathologies
Blood Glucose ProfileAutres identifiants de l'étude
- TBD-2
Numéro NCT
Date de début (réel)
2021-01-01
Dernière mise à jour publiée
2022-03-25
Date de fin (estimée)
2022-03-01
Type d'étude
Interventionnel
PHASE
N/A
Statut
Retiré
Mots clés
continuous glucose monitoring, lifestyle medicine
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPilot Eligible subjects who have consented to the study, and have had the baseline data gathered as part of their participation in the Lifestyle Medicine Clinic, an intensive therapeutic lifestyle medicine program, will be given a CGMs device and supplies, and instructed in how to utilize these. They will set up the app on their smart phone to provide them with feedback on their glucose level to correlate with their lifest...Afficher plus | Temporary Continuous Glucose Monitoring System This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in an intensive therapeutic lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD). |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Blood glucose profile | The blood glucose profile will be evaluated for out of range values | 12 weeks |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
participant survey | 1. Specifically concerning the Diabits software:
1. What did you like about Diabits?
2. What didn't you like about Diabits?
3. Do you think Diabits has improved your blood sugar management?
2. Did you complete the data entry most of the time? If not, please explain, and make suggestions on how the experience could be improved.
3. Did you have any difficulty managing the sensor or device? If so, please explain, and make suggestions on how the experience could be improved.
4. Overall, did you feel that the continuous glucose monitoring system was helpful? Please explain your answer. How was it helpful or unhelpful?
5. What else should we know or would you like to tell us? | 12 weeks |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- be able to read and write English.
- be enrolled in The Lifestyle Medicine Clinic, taught by Dr. Drozek
- be diagnosed with type 2 diabetes (T2DM) or prediabetes (PDM)
- be at least 18 years of age
- be comfortable wearing a sensor continuously for up to 10 weeks
- have a smart phone and be comfortable utilizing apps
- be able and willing to daily enter data concerning food consumed, exercise, stress management activities and sleep.
- be willing to complete a daily reflection on the relationship of their blood sugar to lifestyle activities.
- be willing to complete a survey at the completion of the project about their perceptions of utilizing continuous glucose monitoring (CGM)
Partie responsable de l'étude
David Drozek, Investigateur principal, Associate Professor, Ohio University
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
Ohio
Marietta Memorial Hospital, Marietta, Ohio, 45750, United States