Trial Outcomes & Findings for Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators (NCT NCT04057248)
NCT ID: NCT04057248
Last Updated: 2021-06-04
Results Overview
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.
COMPLETED
NA
14 participants
During 3 Months
2021-06-04
Participant Flow
No significant events occurred after study participant enrollment. 2 people were inactive.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 participants were inactive during the study
Baseline characteristics by cohort
| Measure |
Individual's Quality of Life and Clinical Parameters
n=14 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=14 Participants
|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 9.9 • n=14 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
|
HBA1C>8.5
|
10.2 percentage of HBA1C in blood
STANDARD_DEVIATION 1.6 • n=12 Participants • 2 participants were inactive during the study
|
|
Weight
|
233.9 lbs
STANDARD_DEVIATION 59.3 • n=12 Participants • 2 participants were inactive during the study
|
|
Total Cholesterol
|
180.3 mg/dL
STANDARD_DEVIATION 53.1 • n=12 Participants • 2 participants were inactive during the study
|
|
Triglycerides value
|
192.5 mg/dL
STANDARD_DEVIATION 113.9 • n=12 Participants • 2 participants were inactive during the study
|
PRIMARY outcome
Timeframe: During 3 MonthsChange 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.
Outcome measures
| Measure |
Individual's Quality of Life and Clinical Parameters
n=12 Participants
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
|
|---|---|
|
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 outcome
Timeframe: During 3 monthsChange 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,
Outcome measures
| Measure |
Individual's Quality of Life and Clinical Parameters
n=12 Participants
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
|
|---|---|
|
Cholesterol Value at 3 Months From Subject Start of Study
|
179.0 mg/dL
Standard Deviation 70.5
|
SECONDARY outcome
Timeframe: During 3 monthsChange 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.
Outcome measures
| Measure |
Individual's Quality of Life and Clinical Parameters
n=12 Participants
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
|
|---|---|
|
Weight Value at 3 Months From Subject Start of Study
|
230.7 lbs
Standard Deviation 58
|
SECONDARY outcome
Timeframe: During 3 monthsChange 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,
Outcome measures
| Measure |
Individual's Quality of Life and Clinical Parameters
n=12 Participants
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
|
|---|---|
|
Triglycerides Value at 3 Months From Subject Start of Study
|
172.0 mg/dL
Standard Deviation 121.5
|
Adverse Events
Individual's Quality of Life and Clinical Parameters
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alan Schorr
Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place