Clinical trial NCT01630759: Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study
Official title: Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Gestational diabetes
telemonitoring
telehealth
feasibility study
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Western Health and Social Care Trust
name: Letterkenny General Hospital
name: University College Hospital Galway
First posted: 2012-06-28
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Pregnant
* Gestational Diabetes or IGT following an oral glucose tolerance test performed at the 24-28 week screening appointment
* Able to use the telehealth equipment following training by staff from the company providing telehealth services
* Have sufficient communication skills \[hearing, speech \& language\] to be fully involved.
* Willing to use one of the approved blood glucose meters for self monitoring of blood glucose, for the duration of the study.

Exclusion Criteria:

* Previously diagnosed Type 1 diabetes or Type 2 diabetes as evidenced by medical records.
* Other diagnosed medical problems or medical therapy such as steroid therapy that would influence blood glucose control and to be decided by the endocrinologist prior to recruitment. Such exclusions to be noted by the endocrinologist or diabetes nurse specialist.
* Previous gestational diabetes is not an exclusion criterion.

Primary outcomes:
measure: Patient satisfaction
timeFrame: At 36-39 weeks gestation
measure: Health care staff satisfaction
timeFrame: At completion of the study estimated to be January 2013
measure: Management decision comparison
timeFrame: At weekly clinic or telemonitoring review from time recruited into study to delivery, estimated at an average of twelve weeks.
Secondary outcomes:
measure: HbA1c
timeFrame: Monthly for duration of participation in study, estimated at 2-3 months
measure: Mean fasting blood glucose
timeFrame: Weekly for duration of participation in study, estimated at 12 weeks
measure: Blood pressure
timeFrame: Weekly for duration of participation in study, estimated at 12 weeks
measure: Gestational age at delivery
timeFrame: At delivery
measure: Type of delivery
timeFrame: At delivery
measure: Pre-eclampsia
timeFrame: At delivery
measure: Documented problems with pregnancy
timeFrame: At delivery
measure: Weight of baby
timeFrame: At birth
measure: Apgar score
timeFrame: At birth
measure: Admission to neonatal unit
timeFrame: At one day after birth
measure: Respiratory distress
timeFrame: At one day after birth
measure: Jaundice
timeFrame: At one day after birth
measure: Neonatal hypoglycaemia
timeFrame: At one day after birth
measure: Shoulder dystocia
timeFrame: At birth
measure: Malformations
timeFrame: At delivery
measure: Post-prandial blood glucose
timeFrame: Weekly for duration of participation in study, estimated at 12 weeks
measure: Length of baby
timeFrame: At birth
measure: Macrosomia
timeFrame: At birth
measure: Head circumference
timeFrame: At birth
measure: Average number of monitoring episodes per day
timeFrame: At delivery
measure: Number of downloads missed
timeFrame: At delivery
Other outcomes:
Locations:
city: Letterkenny
country: Ireland
facility: Letterkenny General Hospital
state: Donegal
city: Londonderry
country: United Kingdom
facility: Altnagelvin Hospital
Study officials:
affiliation: University of Ulster
name: Vivien E Coates, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Given JE, Bunting BP, O'Kane MJ, Dunne F, Coates VE. Tele-Mum: A Feasibility Study for a Randomized Controlled Trial Exploring the Potential for Telemedicine in the Diabetes Care of Those with Gestational Diabetes. Diabetes Technol Ther. 2015 Dec;17(12):880-8. doi: 10.1089/dia.2015.0147. Epub 2015 Sep 22.