An interventional study of Dario Blood Glucose Monitoring System and CDE in Diabetes Mellitus, Type 2, sponsored by LabStyle Innovations Ltd.. Completed at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2021-06-04.
Sponsored by LabStyle Innovations Ltd. · Not applicable, Interventional, and Supportive care
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 14 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →LabStyle Innovations Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be eligible to participate in this study, a subject must meet all the following criteria:
Exclusion Criteria:
Patients provided with digital platform and connected devices. They undergo digital and human (CDE) intervention based on patient captured clinical data. Clinical parameters (HbA1C, weight, lipids profile, etc.) before and after intervention is assessed.
Device: Dario Blood Glucose Monitoring System · Behavioral: CDE
Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform
Certified Diabetes Educator Sessions
HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline
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
Cholesterol Value at 3 Months From Subject Start of Study
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
Weight Value at 3 Months From Subject Start of Study
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
Triglycerides Value at 3 Months From Subject Start of Study
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,
Time frame: During 3 months
| Milestone | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Started | 14 |
| Completed | 12 |
| Not completed | 2 |
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.
| percentage of HBA1C in blood | Individual's Quality of Life and Clinical Parameters |
|---|---|
| HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline | 8.2 ± 1.4 |
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,
| mg/dL | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Cholesterol Value at 3 Months From Subject Start of Study | 179.0 ± 70.5 |
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.
| lbs | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Weight Value at 3 Months From Subject Start of Study | 230.7 ± 58 |
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,
| mg/dL | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Triglycerides Value at 3 Months From Subject Start of Study | 172.0 ± 121.5 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Individual's Quality of Life and Clinical Parameters | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Individual's Quality of Life and Clinical Parameters |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 2 |
| Age, Continuous(years) | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Mean | 55.4 ± 9.9 |
| Sex: Female, Male(Participants) | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Female | 4 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Individual's Quality of Life and Clinical Parameters |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Individual's Quality of Life and Clinical Parameters |
|---|---|
| United States | 14 |
| HBA1C>8.5(percentage of HBA1C in blood) | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Mean | 10.2 ± 1.6 |
| Weight(lbs) | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Mean | 233.9 ± 59.3 |
| Total Cholesterol(mg/dL) | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Mean | 180.3 ± 53.1 |
1 further baseline measures are reported on the registry.
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LabStyle Innovations Ltd.