NCT04244110

Brief Summary

The objective of this study is to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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

January 17, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 21, 2020

Last Update Submit

January 27, 2021

Conditions

Keywords

diabetesself-managementmHealth

Outcome Measures

Primary Outcomes (1)

  • Usability of the Diacare platform

    System Usability Scale (SUS) is a self-administered questionnaire to evaluate the usability of the developed tool.

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The selected participants will belong to a primary care center based at Hospitalet de Llobregat, Barcelona (Spain).

You may qualify if:

  • People diagnosed with type 2 DM based on clinical criteria
  • People who own a Smartphone and have competences in the use of technology

You may not qualify if:

  • People that cannot go to the primary care center
  • People with cognitive deterioration
  • People with limitations in the practice of physical exercise
  • People with a life expectancy lower than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAP Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rosa Flores, MD

    Institut Català de la Salut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

January 17, 2020

Primary Completion

July 24, 2020

Study Completion

July 24, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations