Study of Welltang- a Cell Phone-based Diabetes Management... | NCT02313090

Studies
Study of Welltang- a Cell Phone-based Diabetes Management Application's Effect on Blood Glucose Control

NCT02313090

Sponsor

First Affiliated Hospital of Zhejiang University

Status

Completed

Last Update Posted

Dec 9, 2014Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Welltang

Countries

Not provided

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

Dec 2014

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

Jan 2014

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Nov 25, 2014

First Submission Date that Met QC Criteria

Dec 7, 2014

First Posted Date

Dec 9, 2014Estimated

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

Dec 7, 2014

Last Update Posted Date

Dec 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhou Weibin, Prime investigator, First Affiliated Hospital of Zhejiang UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim was to assess the impact of a cell phone-based diabetes management application (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang, their diabetes knowledge and self-care behaviors were also evaluated.

Detailed Description

At baseline, all patients completed the Diabetes Self- Care Behavior Questionnaire and a Diabetes Knowledge Survey. Health, medical and demographic history, height and weight, waist and hip circumferences, and blood pressure were recorded. HbA1c and low-density lipoprotein cholesterol (LDL-C) level were tested. All of these data were measured 3 months later at the conclusion of the study intervention.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Welltang	Experimental	patients using Welltang	Other: Welltang
usual standard care	No Intervention	patients under usual standard of diabetic care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Welltang	Other	The intervention group installed Welltang (downloaded from www.welltang.com for free) designed by Shanghai Geping Information and Technique Company Ltd (Shanghai, China) on their cell phones. Welltang is a cell phone- based diabetes management application that consists of three main parts: knowledge, self-management, communication between patients and clinicians

Measure	Description	Time Frame
HbA1c		3 months

Measure	Description	Time Frame
blood pressure		3 months
low density lipoprotein cholesterol		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All diabetes, aged more than 18 years old. No limit for HbA1c was defined

Exclusion Criteria:

patients have any severe complications such as end phase of diabetic nephropathy or proliferative retinopathy. patients who cannot use smart phone.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weibin Zhou, phD	the First Affiliated Hospital to Zhejiang University School of Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided