NCT02313090

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable diabetes-mellitus

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

4 months

First QC Date

November 25, 2014

Last Update Submit

December 7, 2014

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    3 months

Secondary Outcomes (2)

  • blood pressure

    3 months

  • low density lipoprotein cholesterol

    3 months

Study Arms (2)

Welltang

EXPERIMENTAL

patients using Welltang

Other: Welltang

usual standard care

NO INTERVENTION

patients under usual standard of diabetic care

Interventions

WelltangOTHER

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

Welltang

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Weibin Zhou, phD

    the First Affiliated Hospital to Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prime investigator

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 9, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 9, 2014

Record last verified: 2014-12