Telemonitoring
DeviceUse of telemonitoring facilities to monitor weight, blood pressure and blood sugar during pregnancy complicated by gestational diabetes
NCT Number: NCT01630759
When women with diabetes become pregnant it is particularly important to control blood sugar levels to prevent complications. Women are advised to test their blood glucose levels seven times a day and to attend antenatal and diabetes clinics every 1-2 weeks throughout the pregnancy. For those living in rural areas in the North and West of Ireland getting to a hospital specialising in the management of diabetes and pregnancy on such a regular basis can be a challenge.
Telemonitoring provides a possible solution to this problem by allowing patients to monitor their vital signs at home and transmit the information via telephone to their healthcare provider. If women could be safely monitored remotely for every other appointment it would mean that they would only need to visit the hospital once a month on a routine basis but with the option of attending the hospital if the remote telemonitoring indicated that this were necessary.
The aim of this study is to assess the feasibility and the acceptability of using remote telemonitoring facilities between antenatal women with gestational diabetes and the diabetes team and the possibility of replacing alternate diabetic review clinics with remote telemonitoring. In addition this study will explore the feasibility of running a full randomised control trial of this topic.
Women will be asked to monitor their blood sugar levels seven times a day which is part of usual care. However those in the remote telemonitoring group will be asked to measure their blood sugar using a meter that can transmit the results via a telephone line and to transmit them weekly. They will also be asked to measure their blood pressure and weight weekly and to download these results weekly for a health care professional to review. These results will be reviewed on a weekly basis by a health care professional who will contact the patient if necessary to discuss the results. Women will be followed-up from the date of diagnosis through to delivery.
Both staff and patients will be asked to give their views on the safety and acceptability of remote telemonitoring through questionnaires, focus groups or interviews. The management decisions made on reviewing the intervention group in clinic and reviewing remote telemonitoring results will also be recorded. In order for remote telemonitoring to be a viable replacement for clinic review it must allow health care professionals to make comparable management decisions. Clinical data will be collected in order to provide descriptive statistics for those who take part and to ensure that this information could be collected in any future Randomised Control Trial (RCT) looking at this topic.
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Interventional
Not applicable
Letterkenny General Hospital, Letterkenny, Donegal, Ireland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of telemonitoring facilities to monitor weight, blood pressure and blood sugar during pregnancy complicated by gestational diabetes
The control group will receive usual diabetes/antinatal care. The outcomes from usual care will be compared with the outcomes from the telemonitoring group in order to ensure that it provides comparable care.
Other names: Usual care
Time frame: At 36-39 weeks gestation
The previously validated 'Telemedicine satisfaction and usefulness questionnaire' will be used to assess patient satisfaction with the telemonitoring service.
Qualitative interviews exploring the patient experience of telemonitoring will also be carried out and then analysed using the framework approach. An adapted version of this questionnaire looking specifically at the use of a blood glucose meter will be given to the control group.
Time frame: At completion of the study estimated to be January 2013
The professionals involved in caring for the women using remote telemonitoring technology in antenatal or diabetes clinics will be invited to take part in a focus group at each site. If it is not possible to arrange a time and place suitable for staff in order to hold a focus group it may be necessary to hold one to one structured interviews with staff. The questions used in the focus group will aim to assess the acceptability of telemonitoring to health care staff who use it.
Time frame: At weekly clinic or telemonitoring review from time recruited into study to delivery, estimated at an average of twelve weeks.
Weighted kappa will be used to meaure the level of agreement in between clinic and telemonitoring review management decisions (in excess of the amount of agreement that we would expected by chance). This will allow the determination of inter-rater, intra-rater and inter-institutional agreement between clinic and telemonitoring review management decisions.
Time frame: Monthly for duration of participation in study, estimated at 2-3 months
HbA1c mmol/l and IFCC units
Time frame: Weekly for duration of participation in study, estimated at 12 weeks
mmol/l plasma glucose
Time frame: Weekly for duration of participation in study, estimated at 12 weeks
mmHg
Time frame: At delivery
Gestational age in weeks at delivery
Time frame: At delivery
Vaginal or Caesarean section
Time frame: At delivery
Presence or absence of any pre-eclampsia
Time frame: At delivery
Presence of any documented problems during pregnancy
Time frame: At birth
Weight in kg
Time frame: At birth
Apgar score at one and five minutes (out of 10)
Time frame: At one day after birth
Whether the baby needed admission to the neonatal unit
Time frame: At one day after birth
Presence of any episodes of documented Respiratory distress in first 24 hours of life
Time frame: At one day after birth
Presence of any jaundice in first 24 hours of life
Time frame: At one day after birth
Presence of any documented episodes of neonatal hypoglycaemia in first 24 hours of life
Time frame: At birth
Presence of any shoulder dystocia
Time frame: At delivery
Any malformations at delivery
Time frame: Weekly for duration of participation in study, estimated at 12 weeks
mmol/l plasma glcuose
Time frame: At birth
centimeters
Time frame: At birth
Presence or absence of macrosomia
Time frame: At birth
centimeters
Time frame: At delivery
Average number of monitoring episodes per day
Time frame: At delivery
Number of downloads missed by those in the telemonitoring group
University of Ulster
Other
Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study for a Randomised Controlled Trial
Acronym: Tele-Mum
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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