Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Detailed description
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: 1. Two scheduled phone sessions with a Diabetes health coach a month; 2. Ongoing dual communication with the coach using digital communication channels such as chat, SMS and emails 3. Diabetes education, behavior modification, goal setting and reinforcement. The Dario App will record participant's glucose measurements and additional information captured by the patient such as medication intake, food and physical activity results. The coach will get access to the patients' App captured information and will intervene ad necessary in the context of the clinical information.
Interventions
Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform
BEHAVIORALCDE
Certified Diabetes Educator Sessions
Sponsors
LabStyle Innovations Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this study, a subject must meet all the following criteria: 1. Adults 35 years of age or older 2. Diagnosed type 2 Diabetes 3. HbA1C test taken less than 2 months ago and is equal to or above 8.5% 4. Able to read, write and understand English 5. Have supported smartphone (see appendix C for the full smartphone list) with internet package for their service provider 6. The subject is able and agrees to sign the informed consent form
Exclusion criteria
1. Adults with impaired cognition 2. Cohabiting with a participant in the study 3. Have an underlying medical condition (such as kidney disease, hemoglobin variants, anemia) that may provide misleading A1C levels 4. Subject is critically ill 5. Subject has an impairment that prevents him/her from following the study procedures 6. Subject is not using medication that may interfere with the blood glucose measurement 7. HCT level which are outside Dario BGMS declared range (20%-60%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol Value at 3 Months From Subject Start of Study | 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, |
| Weight Value at 3 Months From Subject Start of Study | 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. |
| Triglycerides Value at 3 Months From Subject Start of Study | 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, |
Countries
United States
Participant flow
Pre-assignment details
No significant events occurred after study participant enrollment. 2 people were inactive.
Participants by arm
| Arm | Count |
|---|---|
| Individual's Quality of Life and Clinical Parameters Clinical parameters (HbA1C, weight, lipids profile, etc.)
Dario Blood Glucose Monitoring System: Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform
CDE: Certified Diabetes Educator Sessions | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Individual's Quality of Life and Clinical Parameters |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 55.4 years STANDARD_DEVIATION 9.9 |
| HBA1C>8.5 | 10.2 percentage of HBA1C in blood STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 10 Participants |
| Total Cholesterol | 180.3 mg/dL STANDARD_DEVIATION 53.1 |
| Triglycerides value | 192.5 mg/dL STANDARD_DEVIATION 113.9 |
| Weight | 233.9 lbs STANDARD_DEVIATION 59.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual's Quality of Life and Clinical Parameters | HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline | 8.2 percentage of HBA1C in blood | Standard Deviation 1.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual's Quality of Life and Clinical Parameters | Cholesterol Value at 3 Months From Subject Start of Study | 179.0 mg/dL | Standard Deviation 70.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual's Quality of Life and Clinical Parameters | Triglycerides Value at 3 Months From Subject Start of Study | 172.0 mg/dL | Standard Deviation 121.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual's Quality of Life and Clinical Parameters | Weight Value at 3 Months From Subject Start of Study | 230.7 lbs | Standard Deviation 58 |