NCT04057248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 30, 2021

Completed
Last Updated

June 4, 2021

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

August 13, 2019

Results QC Date

February 2, 2021

Last Update Submit

May 9, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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.

    During 3 Months

Secondary Outcomes (3)

  • Cholesterol Value at 3 Months From Subject Start of Study

    During 3 months

  • Weight Value at 3 Months From Subject Start of Study

    During 3 months

  • Triglycerides Value at 3 Months From Subject Start of Study

    During 3 months

Study Arms (1)

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.

Device: Dario Blood Glucose Monitoring SystemBehavioral: CDE

Interventions

Dario Blood Glucose Monitoring SystemDEVICE

Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform

Digital platform and CDE coaching intervention for patients with type 2 Diabetes
CDEBEHAVIORAL

Certified Diabetes Educator Sessions

Digital platform and CDE coaching intervention for patients with type 2 Diabetes

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)

Feasterville, Pennsylvania, 19047-1845, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Alan Schorr
Organization
Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
abs@sugardoc.com
2157501691

Study Officials

  • Alan Schorr, Dr.

    Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

July 9, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 4, 2021

Results First Posted

March 30, 2021

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)