Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study for a Randomised Controlled Trial
Brief Summary: 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.


Options:
A: Arm Label: Telemonitoring; Type: EXPERIMENTAL; Interventions: Device: Telemonitoring | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Control | Intervention Type: DEVICE; Name: Telemonitoring; Assigned to Arm(s): Telemonitoring | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control group
B: Arm Label: telemedicine; Type: EXPERIMENTAL; Interventions: Behavioral: telemedicine | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: telemedicine; Assigned to Arm(s): telemedicine
C: Arm Label: Nutritional counseling & self blood glucose monitoring; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: nutritional counseling, Behavioral: self blood glucose monitoring | Arm Label: No treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: nutritional counseling; Assigned to Arm(s): Nutritional counseling & self blood glucose monitoring | Intervention Type: BEHAVIORAL; Name: self blood glucose monitoring; Assigned to Arm(s): Nutritional counseling & self blood glucose monitoring
D: Arm Label: Smart phone app glucose monitoring; Type: EXPERIMENTAL; Interventions: Device: Blue tooth enabled glucose meter with smart phone application, Behavioral: Self home blood glucose monitoring | Arm Label: Standard glucose monitoring; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self home blood glucose monitoring | Intervention Type: DEVICE; Name: Blue tooth enabled glucose meter with smart phone application; Assigned to Arm(s): Smart phone app glucose monitoring | Intervention Type: BEHAVIORAL; Name: Self home blood glucose monitoring; Assigned to Arm(s): Smart phone app glucose monitoring, Standard glucose monitoring

Answer: A