Intelligent and Educational System for Gestational Diabetes Management
|ClinicalTrials.gov Identifier: NCT01850199|
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : July 28, 2016
|Condition or disease||Intervention/treatment|
|Gestational Diabetes||Other: Smart telemedicine remote monitoring for gestational diabetes Other: Usual management|
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
- 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 (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||January 2014|
|Primary Completion Date :||September 2015|
|Study Completion Date :||September 2015|
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.
- 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.
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850199
|Parc Tauli Sabadell University Hospital|
|Sabadell, Barcelona, Spain, 08208|