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Clinical Trials/NCT01850199
NCT01850199CompletedNot Applicable

Intelligent and Educational System for Gestational Diabetes Management

Corporacion Parc Tauli1 site in 1 country120 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Median blood glucose (Interquartile range)

Study Overview

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.

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 46 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Usual management (presential visits)

Active Comparator

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

Intervention: Usual management (Other)

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

Intervention: Smart telemedicine remote monitoring for gestational diabetes (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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))

Investigators

Sponsor
Corporacion Parc Tauli
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mercedes Rigla

Director, Endocrinology and Nutrition Dpt.

Corporacion Parc Tauli

Study Sites (1)

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