SOKARY Mobile Application With Type II Diabetes | NCT04843592

Studies
SOKARY Mobile Application With Type II Diabetes

NCT04843592

Sponsor

Magda Bayoumi

Status

Completed

Last Update Posted

Apr 13, 2021Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Type II Diabetes

Interventions

SOKARY Mobile

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2019Actual

Primary Completion Date

Dec 15, 2019Actual

Completion Date

May 30, 2020Actual

First Submitted Date

Apr 9, 2021

First Submission Date that Met QC Criteria

Apr 12, 2021

First Posted Date

Apr 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2021

Last Update Posted Date

Apr 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Android mobile application named (SOKARY)

Detailed Description

Android mobile application named (SOKARY) which means diabetes was selected as an example of mobile health application as it has the advantage of Arabic interface, free use it allows users to record his/their blood glucose level, nutrition and physical activity, then provide the user with statistics for those readings. The application also sends notifications to the users such as medication reminders and healthy lifestyle advice.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Type II diabetes		using mobile app	Device: SOKARY Mobile

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SOKARY Mobile	Device	Effectiveness of using SOKARY Mobile Application on compliance of patient with Type II diabetes	Type II diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the patient's compliance after using SOKARY mobile app	Increase level of Patients' compliance	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be familiar with the use of mobile health applications.
Own a smartphone with an android operating system.
Able to use the internet either through Wi-Fi network and\or mobile data.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

patient with type II DM

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D010349	Patient Compliance

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided