Gestational DiabetesNCT01850199
Intelligent and Educational System for Gestational Diabetes Management
A study testing Smart telemedicine remote monitoring for gestational diabetes and Usual management in people with Gestational Diabetes, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Smart telemedicine remote monitoring for gestational diabetes and Usual management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnancy; Gestational diabetes diagnosed according the National Diabetes data Group Criteria.
Who cannot join
- Pregestational diabetes (diagnosed or suspected); Illiteracy; no computer connected to internet availability; unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Gestational Diabetes
- Being tested
- Smart telemedicine remote monitoring for gestational diabetes, Usual management
- Keywords
- Gestational diabetes, Telemedicine, Artificial Intelligence
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart telemedicine remote monitoring for gestational diabetesOther
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.
Usual managementOther
Usual care will be provided, including face-to-face visits
| Study group | Role | What they receive |
|---|---|---|
| Usual management (presential visits) | Active comparator | Patient will follow the usual care program, which includes in-person appointment (weekly/biweekly) Receives: 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 Receives: Other: Smart telemedicine remote monitoring for gestational diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median blood glucose (Interquartile range)
Blood glucose data downloaded from the glucometer will allow to obtain the main outcome.
Measured: From inclusion to delivery (estimate average period 10±2 weeks)
Secondary outcomes (1)
Time from glucose criteria for insulin prescription to actual insulin starting
Measured: From inclusion to delivery From inclusion to delivery (estimate average period 10±2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- CIBER-BBN: Networking Research Center for Bioengineering., Technical University of Madrid
- Responsible party
- Principal investigator, Mercedes Rigla, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850199
- Sponsor's protocol ID
- SINEDiE
- Status last verified
- Jul 2016
- First submitted
- 3 May 2013
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent and Educational System for Gestational Diabetes Management
- ClinicalTrials.gov ID
- NCT01850199
- Acronym / sponsor ID
- SINEDiE
- Conditions
- Gestational Diabetes
- Keywords
- Gestational diabetes, Telemedicine, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- CIBER-BBN: Networking Research Center for Bioengineering., Technical University of Madrid
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual management (presential visits) | Active comparator | Other: Usual managementPatient will follow the usual care program, which includes in-person appointment (weekly/biweekly) |
| Smart telemedicine remote monitoring for gestational diabetes | Experimental | Other: Smart telemedicine remote monitoring for gestational diabetesAfter 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 |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnancy; Gestational diabetes diagnosed according the National Diabetes data Group Criteria.
Key exclusion criteria (1 listed)
- Pregestational diabetes (diagnosed or suspected); Illiteracy; no computer connected to internet availability; unwillingness to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart telemedicine remote monitoring for gestational diabetesIntervention 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. | Other | Smart telemedicine remote monitoring for gestational diabetes |
| Usual managementUsual care will be provided, including face-to-face visits | Other | Usual management (presential visits) |
Primary outcome
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.
1 secondary 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart telemedicine remote monitoring for gestational diabetes and Usual management in people with Gestational Diabetes, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median blood glucose (Interquartile range) (time frame: From inclusion to delivery (estimate average period 10±2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.