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Gestational Diabetes MellitusTREAT-GDMNCT01916694

Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus

A study testing Blue tooth enabled glucose meter with smart phone application and Self home blood glucose monitoring in people with Gestational Diabetes Mellitus and Pregnancy, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems for both mothers-to-be and their babies such as causing a large baby and difficult birth. Gestational diabetes in the mother may also lead to effects on the long term health of the baby. Most people today use mobile phones. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Gestational Diabetes Mellitus, Pregnancy
What is being tested?
Blue tooth enabled glucose meter with smart phone application and Self home blood glucose monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2013to Feb 2016
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 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant women with an abnormal 75 gram 2 hour glucose tolerance test as defined by the IADPSG (International Association of Diabetes in Pregnancy Study Group)
  • Willingness and able to give informed consent
  • Female aged between 18-40 years
  • Singleton pregnancy
  • Able to travel to hospital independently

Who cannot join

  • Impaired cognitive function such that she is unable to operate m-health equipment
  • Any evidence of fetal compromise
  • Known risk factors for obstetric complications, other than obesity and diabetes
  • Gestational diabetes requiring immediate pharmacologic treatment
  • Twins or higher order pregnancy
  • OGTT (Oral Glucose Tolerance Test) suggesting preexisting diabetes (fasting blood glucose >= 7.0 or 2 hour >= 11.1 mmol/L
  • Gestation greater than 34+6 at the time of potential recruitment
  • Unable to speak English well enough to explain or use equipment

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • John Radcliffe Hospital

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

About this study

Official title: A Randomised Pilot Trial to Compare Remote Blood Glucose Monitoring With Standard Clinical Care in the Gestational Diabetic Population

Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems for both mothers-to-be and their babies such as causing a large baby and difficult birth. Gestational diabetes in the mother may also lead to effects on the long term health of the baby.

Most people today use mobile phones. Our research is looking at using a mobile phone app to help with diabetes care in pregnancy. In particular, the investigators are using phones which connect to the standard blood glucose monitoring machines given to all women with gestational diabetes to see if sending the hospital team blood test results between clinic appointments can result in the need for fewer clinic visits. The investigators are also testing to see how acceptable using mobile phones in this way, is to our patients and that the control of the blood glucose and outcomes for the mother and baby are at least as good as standard care.

Read more

The investigators are planning to recruit 200 women who receive care for their gestational diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be randomised so that 100 will receive standard care, and 100 will have a mobile phone "app" linked to the blood glucose machines to send blood glucose readings directly to the diabetes care team to review.

Both groups will be asked to test their blood glucose levels at home regularly with a glucometer. All participants will also be given lifestyle advice to reduce the chance they will need medication. Blood glucose control will be measured also by the percentage of glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before delivery.

Being tested
Blue tooth enabled glucose meter with smart phone application, Self home blood glucose monitoring
Keywords
Gestational diabetes mellitus, m Health, Smartphone, Blood glucose monitoring
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blue tooth enabled glucose meter with smart phone applicationDevice

  • Self home blood glucose monitoringBehavioural

    Fingerprick testing of blood glucose levels before and 2 hours after meals

Study groups in NCT01916694
Study groupRoleWhat they receive
Smart phone app glucose monitoringExperimentalHome blood glucose monitoring results directly transmitted via a bluetooth enabled smart phone app to a central database to be reviewed by clinicians
Receives: Device: Blue tooth enabled glucose meter with smart phone application; Behavioral: Self home blood glucose monitoring
Standard glucose monitoringActive comparatorHome blood glucose monitoring results recorded by hand in a paper diary by the patient and reviewed by the clinical team in the outpatient clinic.
Receives: Behavioral: Self home blood glucose monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycosylated haemogloblin

    Glycosylated haemoglobin (HbA1C) will be measured at the time of recruitment (around 28 weeks gestation) and at 36 weeks gestation. This will be approximately 8 weeks after recruitment (time 0).

    Measured: 8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation

Secondary outcomes (8)

  1. Mean Blood glucose levels for fasting, pre-prandial and post-prandial readings

    Mean blood glucose levels for all readings measured fasting, pre-prandial and post prandial will be calculated over the 10 week participation in the trial (from recruitment at 28 weeks gestation to delivery at 38 weeks gestation).

    Measured: 10 weeks (from 28 weeks gestation to 38 weeks gestation)

  2. Percentage of 'on target' blood glucose readings

    Fasting readings as defined >=3.5 and <=5.8 mmol/L and post prandial readings >= 3.5 and <= 7.7 mmol/L for the first four weeks after randomisation and the second four weeks after randomisation

    Measured: 8 weeks (from recruitment at 28 weeks gestation to 36 weeks gestation)

  3. Effectiveness of monitoring

    Time to first trigger point (intensive dietary and lifestyle advice and increase monitoring to 7 days home per week) Time to second trigger point (insulin or metformin therapy) Time to treatment Number of changes to hypoglycaemics Maximum dose of insulin and metformin

    Measured: 10 weeks (from 28 weeks gestation to 38 weeks gestation)

  4. Maternal outcomes

    Perineal trauma (defined as third or fourth degree tear), pregnancy induced hypertension and preeclampsia, admission to higher level of care for mother. This will be measured up to 7 days post delivery (if birth is at 38 weeks, this will be 11 weeks after trial recruitment, unless birth occurs earlier)

    Measured: Approximately 11 weeks after recruitment

  5. Maternal weight gain,

    Weight gain in kilograms from trial recruitment until last antenatal visit prior to delivery

    Measured: 10 weeks (from 28 weeks gestation to 38 weeks gestation)

  6. Birthweight

    Z score of weight in kilograms for gestational age at delivery and Birthweight greater than 4.5kg

    Measured: At birth (approximately 10 weeks after trial recruitment)

  7. Birth injury

    Fracture of clavicle or humerus or other injury attributed to difficult birth, such as Erbs palsy or skull fracture

    Measured: At birth (approximately 10 weeks after trial recruitment)

  8. Neonatal hypoglycaemia

    Documented blood glucose level <2.5mmol/L or requiring parenteral feeding within the first 48 hours of life after birth at around 38 weeks gestation (birth at approximately 10 weeks following trial recruitment and blood glucose monitoring in the neonate up to 48 hours after this)

    Measured: Approximately 10.5 weeks after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01916694
Sponsor's protocol ID
13/SC/0176
Acronym
TREAT-GDM
Status last verified
May 2016
First submitted
4 Jul 2013
Last updated
20 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Mackillop L, Hirst JE, Bartlett KJ, Birks JS, Clifton L, Farmer AJ, Gibson O, Kenworthy Y, Levy JC, Loerup L, Rivero-Arias O, Ming WK, Velardo C, Tarassenko L. Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Mar 20;6(3):e71. doi: 10.2196/mhealth.9512.

    PubMed 29559428

  • Mackillop LH, Bartlett K, Birks J, Farmer AJ, Gibson OJ, Kevat DA, Kenworthy Y, Levy JC, Loerup L, Tarassenko L, Velardo C, Hirst JE. Trial protocol to compare the efficacy of a smartphone-based blood glucose management system with standard clinic care in the gestational diabetic population. BMJ Open. 2016 Mar 17;6(3):e009702. doi: 10.1136/bmjopen-2015-009702.

    PubMed 26988348

  • Hirst JE, Mackillop L, Loerup L, Kevat DA, Bartlett K, Gibson O, Kenworthy Y, Levy JC, Tarassenko L, Farmer A. Acceptability and user satisfaction of a smartphone-based, interactive blood glucose management system in women with gestational diabetes mellitus. J Diabetes Sci Technol. 2015 Jan;9(1):111-5. doi: 10.1177/1932296814556506. Epub 2014 Oct 30.

    PubMed 25361643

Questions about this trial

What is this clinical trial studying?

A study testing Blue tooth enabled glucose meter with smart phone application and Self home blood glucose monitoring in people with Gestational Diabetes Mellitus and Pregnancy, run by University of Oxford at 1 site in United Kingdom.

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 8 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Glycosylated haemogloblin (time frame: 8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation). 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 NCT01916694, which also lists 3 linked publications.

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 20 May 2016.

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