Diabetes Mellitus, Type 2NCT04057248
Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators
A study testing Dario Blood Glucose Monitoring System and CDE in people with Diabetes Mellitus, Type 2, run by LabStyle Innovations Ltd. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dario Blood Glucose Monitoring System and CDE
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, a subject must meet all the following criteria:
- Adults 35 years of age or older
- Diagnosed type 2 Diabetes
- HbA1C test taken less than 2 months ago and is equal to or above 8.5%
- Able to read, write and understand English
- Have supported smartphone (see appendix C for the full smartphone list) with internet package for their service provider
- The subject is able and agrees to sign the informed consent form
Who cannot join
- Adults with impaired cognition
- Cohabiting with a participant in the study
- Have an underlying medical condition (such as kidney disease, hemoglobin variants, anemia) that may provide misleading A1C levels
- Subject is critically ill
- Subject has an impairment that prevents him/her from following the study procedures
- Subject is not using medication that may interfere with the blood glucose measurement
- HCT level which are outside Dario BGMS declared range (20%-60%)
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
Feasterville, Pennsylvania, 19047-1845
About this study
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.
Read the 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:
- Two scheduled phone sessions with a Diabetes health coach a month;
- Ongoing dual communication with the coach using digital communication channels such as chat, SMS and emails
- 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dario Blood Glucose Monitoring System, CDE
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dario Blood Glucose Monitoring SystemDevice
Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform
CDEBehavioural
Certified Diabetes Educator Sessions
| Study group | Role | What they receive |
|---|---|---|
| Digital platform and CDE coaching intervention for patients with type 2 Diabetes | Experimental | 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. Receives: Device: Dario Blood Glucose Monitoring System; Behavioral: CDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 3 Months
Secondary outcomes (3)
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,
Measured: 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.
Measured: 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,
Measured: During 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start9 Jul 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- LabStyle Innovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Schorr, Dr., Principal investigator, Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057248
- Sponsor's protocol ID
- CP-0010
- Status last verified
- Sep 2019
- First submitted
- 13 Aug 2019
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators
- ClinicalTrials.gov ID
- NCT04057248
- Acronym / sponsor ID
- CP-0010
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- LabStyle Innovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Posted 30 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Two scheduled phone sessions with a Diabetes health coach a month;
- Ongoing dual communication with the coach using digital communication channels such as chat, SMS and emails
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital platform and CDE coaching intervention for patients with type 2 Diabetes | Experimental | Device: Dario Blood Glucose Monitoring System, Behavioral: CDEPatients 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be eligible to participate in this study, a subject must meet all the following criteria:
- Adults 35 years of age or older
- Diagnosed type 2 Diabetes
- HbA1C test taken less than 2 months ago and is equal to or above 8.5%
- Able to read, write and understand English
Key exclusion criteria (7 listed)
- Adults with impaired cognition
- Cohabiting with a participant in the study
- Have an underlying medical condition (such as kidney disease, hemoglobin variants, anemia) that may provide misleading A1C levels
- Subject is critically ill
- Subject has an impairment that prevents him/her from following the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dario Blood Glucose Monitoring SystemDario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform | Device | Digital platform and CDE coaching intervention for patients with type 2 Diabetes |
| CDECertified Diabetes Educator Sessions | Behavioural | Digital platform and CDE coaching intervention for patients with type 2 Diabetes |
Primary outcome
HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline
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.
3 secondary outcomes
Cholesterol Value at 3 Months From Subject Start of Study
Time frame: During 3 months
Weight Value at 3 Months From Subject Start of Study
Time frame: During 3 months
Triglycerides Value at 3 Months From Subject Start of Study
Time frame: During 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Schorr, Dr. principal investigator
Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dario Blood Glucose Monitoring System and CDE in people with Diabetes Mellitus, Type 2, run by LabStyle Innovations Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline (time frame: During 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.