Intelligent and Educational System for Gestational Diabetes Management

July 27, 2016 updated by: Mercedes Rigla, Corporacion Parc Tauli
Gestational diabetes, diabetes diagnosed during pregnancy, affects 8.8% of pregnancies in Spain that means more than 40,000 women per year. This prevalence is based on the National Diabetes Data Group criteria, previous to the 4th workshop on Gestational Diabetes (1998), but, if the new diagnosis criteria proposed by the International Associations of Diabetes and Pregnancy Study Groups, based on the most important study never made before on this topic, prevalence would increase to the double. When a women is diagnosed, the risk of complications for her and the child increases and, therefore, she has to start an specific diet and frequent visits to the diabetes center in order to check that glucose values do not exceed 95 mg/dl before or 140 mg/dl 1-hour after meals. In other case, she should start insulin treatment. Our project is aimed to develop intelligent tools based on neuro-diffuse techniques and integrated in a telemedicine system that allows control of gestational diabetes automatically, guaranteeing glucose control objectives consecution and avoiding face-to-face visits to the health care center. Furthermore, educational and motivation tools for a healthy behaviour will be included. At the end of the study efficacy and security about insulin management will be compare with the recommendations proposed by the diabetes team and data about direct and indirect costs will be calculated. The investigators anticipate that the smart telemedicine system can allow us to detect high blood glucose values earlier than in-person scheduled visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the safety and usability of a telemedicine system which includes intelligent tools for blood glucose analysis and supporting routine clinical monitoring carried out by nurses and endocrinologists.

Type of study: Prospective, controlled, randomized (2:1) Participants: pregnant women diagnosed with gestational diabetes according to the National Diabetes Data Group criteria between 14 and 34 weeks of gestation. Patients with suspected clinical diagnosis of type 1 or type 2 diabetes will be excluded.

In addition to the signed acceptance to participate in the study, requirements are:

  • Availability of a desktop computer or laptop with an internet connection and USB port.
  • Sufficient knowledge of Catalan and/or Spanish
  • A mobile phone Objective: To technically evaluate the SineDie telemedicine system and also the users' degree of satisfaction.

Methodology of the study: Once signed consent for participation the patient will be randomized either to continue regularly scheduled visits (33% chance) or to use the Telemedicine system (66% chance). The randomization will be done using a system of allocation based on random numbers. The SINEDiE system includes:

  • Educational Program
  • Automatical Evaluation of glucose data -immediately after each download (frequency not exceeding 72 hours)
  • Alerts in case of failure of receiving information at the scheduled time or in case of incompleteness.
  • Alerts for glucose values higher than desirable but which could be corrected by diet changes and / or exercise
  • Alerts for high glucose values which cannot be corrected with the previous mentioned changes. In this case an appointment for face-to-face visit would be made.

All warnings are also reported as an email to the endocrinologist and nurse

Variables:

  • Statistical analysis of data: blood glucose, standard deviation, number of preprandial values> 90, the number of postprandial values of> 140 messages and warnings
  • Analytical variables: HbA1c at the start and every 4 weeks
  • Complications of pregnancy and childbirth if any.
  • Neonatal Complications if any
  • Survey of satisfaction with telemedicine tool

Expected duration of the study: 6 months Number of patients included 20 patients

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Parc Taulí Sabadell University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy; Gestational diabetes diagnosed according the National Diabetes data Group Criteria.

Exclusion Criteria:

  • Pregestational diabetes (diagnosed or suspected); Illiteracy; no computer connected to internet availability; unwillingness to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual management (presential visits)
Patient will follow the usual care program, which includes in-person appointment (weekly/biweekly)
Other: Usual management
Usual care will be provided, including face-to-face visits
Experimental: Smart telemedicine remote monitoring for gestational diabetes
After receiving an structured education on the matter, patients will be followed remotely by analysing glucose and diet/physical activity/other events data with a periodicity no longer than 48 hours
Other: Smart telemedicine remote monitoring for gestational diabetes
Intervention consists of a telemedicine platform which includes artificial intelligence tools to analyse glucose values and guarantee an optimal glucose control from the diagnosis of gestational diabetes to delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median blood glucose (Interquartile range)
Time Frame: From inclusion to delivery (estimate average period 10±2 weeks)
Blood glucose data downloaded from the glucometer will allow to obtain the main outcome.
From inclusion to delivery (estimate average period 10±2 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from glucose criteria for insulin prescription to actual insulin starting
Time Frame: From inclusion to delivery From inclusion to delivery (estimate average period 10±2 weeks)
From inclusion to delivery From inclusion to delivery (estimate average period 10±2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Collaborators

Technical University of Madrid
CIBER-BBN: Networking Research Center for Bioengineering.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SINEDiE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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