NCT01630759

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

June 22, 2012

Last Update Submit

January 24, 2014

Conditions

Gestational Diabetes

Keywords

Gestational diabetestelemonitoringtelehealthfeasibility study

Outcome Measures

Primary Outcomes (3)

  • Patient satisfaction

    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.

    At 36-39 weeks gestation

  • Health care staff satisfaction

    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.

    At completion of the study estimated to be January 2013

  • Management decision comparison

    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.

    At weekly clinic or telemonitoring review from time recruited into study to delivery, estimated at an average of twelve weeks.

Secondary Outcomes (21)

  • HbA1c

    Monthly for duration of participation in study, estimated at 2-3 months

  • Mean fasting blood glucose

    Weekly for duration of participation in study, estimated at 12 weeks

  • Blood pressure

    Weekly for duration of participation in study, estimated at 12 weeks

  • Gestational age at delivery

    At delivery

  • Type of delivery

    At delivery

  • +16 more secondary outcomes

Study Arms (2)

Telemonitoring

EXPERIMENTAL

The telemonitoring group will receive usual care but be asked to download their blood sugar readings and take a blood pressure and weight measurement each week. This will be reviewed by their diabetes health care team to assess the possibility of replacing alternate anti-natal/diabetes clinics with telemonitoring review in a future study. Acceptability to staff and patients will be assessed through a questionnaire (patients only) and qualitative interviews.

Device: Telemonitoring

Control group

ACTIVE COMPARATOR

Control group will consist of usual care and review at clinic.

Other: Control

Interventions

TelemonitoringDEVICE

Use of telemonitoring facilities to monitor weight, blood pressure and blood sugar during pregnancy complicated by gestational diabetes

Telemonitoring
ControlOTHER

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.

Also known as: Usual care
Control group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previously diagnosed Type 1 diabetes or Type 2 diabetes as evidenced by medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Letterkenny General Hospital

Letterkenny, Donegal, Ireland

Location

Altnagelvin Hospital

Londonderry, Londonderry, BT47 6SB, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26394017DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vivien E Coates, PhD

    University of Ulster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2012

First Posted

June 28, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

GB(1)IE(1)