Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
Feasterville, Pennsylvania, 19047-1845, United States
NCT Number: NCT04057248
Each subject enrolled in the study will be requested to complete an intake questionnaire including diabetes quality of life questions. The subject will use Dario Blood glucose monitoring system and will be contacted by a Certified Diabetes Educator (CDE) two to three times a month as well as have a direct communication using other communication channels such as mail, chat and text messaging (SMS) for lifestyle and diabetes management coaching for a total duration of three months. In the end of study, the subject will complete a diabetes quality of life questionnaire and have a blood test to evaluate its clinical parameters.
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Notify Me35 year and older
All sexes
Interventional
Not applicable
Feasterville, Pennsylvania, 19047-1845, United States
This study is designed to assess the effect of digital self-monitoring platform used with the remote support of a Health coach on clinical outcomes and Diabetes quality of life.
Study design will be an open-label randomized trial of adults with Type 2. Patients are recruited through the Diabetes and Endocrinology Consultants center setting. Upon randomization to the intervention group, study participants will receive three months diabetes health coaching comprising of:
The coach will get access to the patients' App captured information and will intervene ad necessary in the context of the clinical information.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To be eligible to participate in this study, a subject must meet all the following criteria:
Exclusion criteria
Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform
Certified Diabetes Educator Sessions
Time frame: During 3 Months
Change of HbA1C taken in blood test 3 month from the subject start of the study.
Data was compared to baseline and reporting the HbA1C change from baseline measurement and 3 months after subject start of the clinical study.
Measurement was conducted by Quest labs.
Time frame: During 3 months
Change of Cholesterol taken in blood test 3 month from the subject start of the study Data was compared to baseline and reporting the Cholesterol change from baseline measurement and 3 months after subject start of the clinical study.
Measurement was conducted by Quest labs,
Time frame: During 3 months
Change of Weight taken in the clinic at the beginning of the study and 3 month from the subject start of the study Data was compared to baseline and reporting the weight change from baseline measurement and 3 months after subject start of the clinical study.
Time frame: During 3 months
Change of Triglycerides taken in blood test 3 month from the subject start of the study Data was compared to baseline and reporting the Triglycerides change from baseline measurement and 3 months after subject start of the clinical study.
Measurement was conducted by Quest labs,
LabStyle Innovations Ltd.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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