Intelligent and Educational System for Gestational Diabetes Management
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|ClinicalTrials.gov Identifier: NCT01850199|
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : July 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Other: Smart telemedicine remote monitoring for gestational diabetes Other: Usual management||Not Applicable|
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|
|Actual Primary Completion Date :||September 2015|
|Actual 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850199
|Parc Tauli Sabadell University Hospital|
|Sabadell, Barcelona, Spain, 08208|