Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study (Tele-Mum)

This study has been completed.
Sponsor:
Collaborators:
Western Health and Social Care Trust
Letterkenny General Hospital
University College Hospital Galway
Information provided by (Responsible Party):
Professor Vivien Coates, University of Ulster
ClinicalTrials.gov Identifier:
NCT01630759
First received: June 22, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Gestational Diabetes
Device: Telemonitoring
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study for a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Ulster:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: At 36-39 weeks gestation ] [ Designated as safety issue: No ]

    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.


  • Health care staff satisfaction [ Time Frame: At completion of the study estimated to be January 2013 ] [ Designated as safety issue: No ]
    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.

  • Management decision comparison [ Time Frame: At weekly clinic or telemonitoring review from time recruited into study to delivery, estimated at an average of twelve weeks. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • HbA1c [ Time Frame: Monthly for duration of participation in study, estimated at 2-3 months ] [ Designated as safety issue: No ]
    HbA1c mmol/l and IFCC units

  • Mean fasting blood glucose [ Time Frame: Weekly for duration of participation in study, estimated at 12 weeks ] [ Designated as safety issue: No ]
    mmol/l plasma glucose

  • Blood pressure [ Time Frame: Weekly for duration of participation in study, estimated at 12 weeks ] [ Designated as safety issue: No ]
    mmHg

  • Gestational age at delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Gestational age in weeks at delivery

  • Type of delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Vaginal or Caesarean section

  • Pre-eclampsia [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Presence or absence of any pre-eclampsia

  • Documented problems with pregnancy [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Presence of any documented problems during pregnancy

  • Weight of baby [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Weight in kg

  • Apgar score [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Apgar score at one and five minutes (out of 10)

  • Admission to neonatal unit [ Time Frame: At one day after birth ] [ Designated as safety issue: No ]
    Whether the baby needed admission to the neonatal unit

  • Respiratory distress [ Time Frame: At one day after birth ] [ Designated as safety issue: No ]
    Presence of any episodes of documented Respiratory distress in first 24 hours of life

  • Jaundice [ Time Frame: At one day after birth ] [ Designated as safety issue: No ]
    Presence of any jaundice in first 24 hours of life

  • Neonatal hypoglycaemia [ Time Frame: At one day after birth ] [ Designated as safety issue: No ]
    Presence of any documented episodes of neonatal hypoglycaemia in first 24 hours of life

  • Shoulder dystocia [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Presence of any shoulder dystocia

  • Malformations [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Any malformations at delivery

  • Post-prandial blood glucose [ Time Frame: Weekly for duration of participation in study, estimated at 12 weeks ] [ Designated as safety issue: No ]
    mmol/l plasma glcuose

  • Length of baby [ Time Frame: At birth ] [ Designated as safety issue: No ]
    centimeters

  • Macrosomia [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Presence or absence of macrosomia

  • Head circumference [ Time Frame: At birth ] [ Designated as safety issue: No ]
    centimeters

  • Average number of monitoring episodes per day [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Average number of monitoring episodes per day

  • Number of downloads missed [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Number of downloads missed by those in the telemonitoring group


Enrollment: 50
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemonitoring
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
Use of telemonitoring facilities to monitor weight, blood pressure and blood sugar during pregnancy complicated by gestational diabetes
Active Comparator: Control group
Control group will consist of usual care and review at clinic.
Other: Control
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 Name: Usual care

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630759

Locations
Ireland
Letterkenny General Hospital
Letterkenny, Donegal, Ireland
United Kingdom
Altnagelvin Hospital
Londonderry, United Kingdom, BT47 6SB
Sponsors and Collaborators
University of Ulster
Western Health and Social Care Trust
Letterkenny General Hospital
University College Hospital Galway
Investigators
Principal Investigator: Vivien E Coates, PhD University of Ulster
  More Information

No publications provided

Responsible Party: Professor Vivien Coates, Professor, University of Ulster
ClinicalTrials.gov Identifier: NCT01630759     History of Changes
Other Study ID Numbers: 11/0016, 11/NI/0023
Study First Received: June 22, 2012
Last Updated: January 24, 2014
Health Authority: United Kingdom: Department of Health

Keywords provided by University of Ulster:
Gestational diabetes
telemonitoring
telehealth
feasibility study

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Pregnancy in Diabetics
Pregnancy Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014