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

January 24, 2014 updated by: Professor Vivien Coates, University of Ulster

Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study for a Randomised Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Donegal
      • Letterkenny, Donegal, Ireland
        • Letterkenny General Hospital
  • United Kingdom
      • Londonderry, United Kingdom, BT47 6SB
        • Altnagelvin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
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.
At 36-39 weeks gestation
Health care staff satisfaction
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.
At completion of the study estimated to be January 2013
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Monthly for duration of participation in study, estimated at 2-3 months
HbA1c mmol/l and IFCC units
Monthly for duration of participation in study, estimated at 2-3 months
Mean fasting blood glucose
Time Frame: Weekly for duration of participation in study, estimated at 12 weeks
mmol/l plasma glucose
Weekly for duration of participation in study, estimated at 12 weeks
Blood pressure
Time Frame: Weekly for duration of participation in study, estimated at 12 weeks
mmHg
Weekly for duration of participation in study, estimated at 12 weeks
Gestational age at delivery
Time Frame: At delivery
Gestational age in weeks at delivery
At delivery
Type of delivery
Time Frame: At delivery
Vaginal or Caesarean section
At delivery
Pre-eclampsia
Time Frame: At delivery
Presence or absence of any pre-eclampsia
At delivery
Documented problems with pregnancy
Time Frame: At delivery
Presence of any documented problems during pregnancy
At delivery
Weight of baby
Time Frame: At birth
Weight in kg
At birth
Apgar score
Time Frame: At birth
Apgar score at one and five minutes (out of 10)
At birth
Admission to neonatal unit
Time Frame: At one day after birth
Whether the baby needed admission to the neonatal unit
At one day after birth
Respiratory distress
Time Frame: At one day after birth
Presence of any episodes of documented Respiratory distress in first 24 hours of life
At one day after birth
Jaundice
Time Frame: At one day after birth
Presence of any jaundice in first 24 hours of life
At one day after birth
Neonatal hypoglycaemia
Time Frame: At one day after birth
Presence of any documented episodes of neonatal hypoglycaemia in first 24 hours of life
At one day after birth
Shoulder dystocia
Time Frame: At birth
Presence of any shoulder dystocia
At birth
Malformations
Time Frame: At delivery
Any malformations at delivery
At delivery
Post-prandial blood glucose
Time Frame: Weekly for duration of participation in study, estimated at 12 weeks
mmol/l plasma glcuose
Weekly for duration of participation in study, estimated at 12 weeks
Length of baby
Time Frame: At birth
centimeters
At birth
Macrosomia
Time Frame: At birth
Presence or absence of macrosomia
At birth
Head circumference
Time Frame: At birth
centimeters
At birth
Average number of monitoring episodes per day
Time Frame: At delivery
Average number of monitoring episodes per day
At delivery
Number of downloads missed
Time Frame: At delivery
Number of downloads missed by those in the telemonitoring group
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulster

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Western Health and Social Care Trust
University College Hospital Galway
Letterkenny General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vivien E Coates, PhD, University of Ulster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11/0016
  • 11/NI/0023 (OTHER: ORECNI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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