Gestational DiabetesTele-MumNCT01630759
Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study
A study testing Telemonitoring in people with Gestational Diabetes, run by University of Ulster at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Telemonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Altnagelvin Hospital
Londonderry, Londonderry, BT47 6SB
About this study
Official title: 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.
Read more
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.
- Conditions
- Gestational Diabetes
- Being tested
- Telemonitoring, Control
- Keywords
- Gestational diabetes, telemonitoring, telehealth, feasibility study
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringDevice
Use of telemonitoring facilities to monitor weight, blood pressure and blood sugar during pregnancy complicated by gestational diabetes
ControlOther
Also called Usual care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Telemonitoring |
| Control group | Active comparator | Control group will consist of usual care and review at clinic. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At weekly clinic or telemonitoring review from time recruited into study to delivery, estimated at an average of twelve weeks.
Secondary outcomes (21)
HbA1c
HbA1c mmol/l and IFCC units
Measured: Monthly for duration of participation in study, estimated at 2-3 months
Mean fasting blood glucose
mmol/l plasma glucose
Measured: Weekly for duration of participation in study, estimated at 12 weeks
Blood pressure
mmHg
Measured: Weekly for duration of participation in study, estimated at 12 weeks
Gestational age at delivery
Gestational age in weeks at delivery
Measured: At delivery
Type of delivery
Vaginal or Caesarean section
Measured: At delivery
Pre-eclampsia
Presence or absence of any pre-eclampsia
Measured: At delivery
Documented problems with pregnancy
Presence of any documented problems during pregnancy
Measured: At delivery
Weight of baby
Weight in kg
Measured: At birth
Apgar score
Apgar score at one and five minutes (out of 10)
Measured: At birth
Admission to neonatal unit
Whether the baby needed admission to the neonatal unit
Measured: At one day after birth
Respiratory distress
Presence of any episodes of documented Respiratory distress in first 24 hours of life
Measured: At one day after birth
Jaundice
Presence of any jaundice in first 24 hours of life
Measured: At one day after birth
Neonatal hypoglycaemia
Presence of any documented episodes of neonatal hypoglycaemia in first 24 hours of life
Measured: At one day after birth
Shoulder dystocia
Presence of any shoulder dystocia
Measured: At birth
Malformations
Any malformations at delivery
Measured: At delivery
Post-prandial blood glucose
mmol/l plasma glcuose
Measured: Weekly for duration of participation in study, estimated at 12 weeks
Length of baby
centimeters
Measured: At birth
Macrosomia
Presence or absence of macrosomia
Measured: At birth
Head circumference
centimeters
Measured: At birth
Average number of monitoring episodes per day
Average number of monitoring episodes per day
Measured: At delivery
Number of downloads missed
Number of downloads missed by those in the telemonitoring group
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Western Health and Social Care Trust, Letterkenny General Hospital, University College Hospital Galway
- Responsible party
- Principal investigator, Professor Vivien Coates, University of Ulster
- Investigators
- Vivien E Coates, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630759
- Sponsor's protocol ID
- 11/0016
- Other IDs
- 11/NI/0023
- Acronym
- Tele-Mum
- Status last verified
- Jan 2014
- First submitted
- 22 Jun 2012
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26394017
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Diabetes in Pregnancy: a Feasibility Study for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01630759
- Acronym / sponsor ID
- Tele-Mum / 11/0016
- Conditions
- Gestational Diabetes
- Keywords
- Gestational diabetes, telemonitoring, telehealth, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Western Health and Social Care Trust, Letterkenny General Hospital, University College Hospital Galway
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Device: TelemonitoringThe 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. |
| Control group | Active comparator | Other: ControlControl group will consist of usual care and review at clinic. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemonitoringUse of telemonitoring facilities to monitor weight, blood pressure and blood sugar during pregnancy complicated by gestational diabetes | Device | Telemonitoring |
| ControlAlso: Usual careThe 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 | Control group |
Primary outcome
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.
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.
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.
21 secondary outcomes
HbA1c
Time frame: 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
Blood pressure
Time frame: Weekly for duration of participation in study, estimated at 12 weeks
Gestational age at delivery
Time frame: At delivery
Type of delivery
Time frame: At delivery
Pre-eclampsia
Time frame: At delivery
Documented problems with pregnancy
Time frame: At delivery
Weight of baby
Time frame: At birth
Apgar score
Time frame: At birth
Admission to neonatal unit
Time frame: At one day after birth
Respiratory distress
Time frame: At one day after birth
Jaundice
Time frame: At one day after birth
Neonatal hypoglycaemia
Time frame: At one day after birth
Shoulder dystocia
Time frame: At birth
Malformations
Time frame: At delivery
Post-prandial blood glucose
Time frame: Weekly for duration of participation in study, estimated at 12 weeks
Length of baby
Time frame: At birth
Macrosomia
Time frame: At birth
Head circumference
Time frame: At birth
Average number of monitoring episodes per day
Time frame: At delivery
Number of downloads missed
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Derived from this study: PubMed 26394017Given 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivien E Coates, PhD principal investigator
University of Ulster
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Gestational Diabetes, run by University of Ulster at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: At 36-39 weeks gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.