Intelligent and Educational System for Gestational Diabetes Management

NCT01850199 | Completed

• 1 other identifier: SINEDiE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Keywords

Gestational diabetes; Telemedicine; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Median blood glucose (Interquartile range)

  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 Outcomes (1)

• Time from glucose criteria for insulin prescription to actual insulin starting

  From inclusion to delivery From inclusion to delivery (estimate average period 10±2 weeks)

Study Arms (2)

Usual management (presential visits)

ACTIVE COMPARATOR

Patient will follow the usual care program, which includes in-person appointment (weekly/biweekly)

Other: Usual management

Smart telemedicine remote monitoring for gestational diabetes

EXPERIMENTAL

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

Interventions

Smart telemedicine remote monitoring for gestational diabetes OTHER

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.

Smart telemedicine remote monitoring for gestational diabetes

Usual management OTHER

Usual care will be provided, including face-to-face visits

Usual management (presential visits)

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• CIBER-BBN: Networking Research Center for Bioengineering.: collaborator
• Technical University of Madrid: collaborator

Study Sites (1)

Parc Tauli Sabadell University Hospital

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Endocrinology and Nutrition Dpt.

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 9, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

ES (1)