Skip to main content
OpenTrials
Completed

NCT Number: NCT01916694

Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus

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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Blue tooth enabled glucose meter with smart phone application

Device

Self home blood glucose monitoring

Behavioral

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

Primary outcomes

  1. Glycosylated haemogloblin

    Time frame: 8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation

    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).

Secondary outcomes

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

    Time frame: 10 weeks (from 28 weeks gestation to 38 weeks gestation)

    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).

  2. Percentage of 'on target' blood glucose readings

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

    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

  3. Effectiveness of monitoring

    Time frame: 10 weeks (from 28 weeks gestation to 38 weeks gestation)

    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

  4. Maternal outcomes

    Time frame: Approximately 11 weeks after recruitment

    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)

  5. Maternal weight gain,

    Time frame: 10 weeks (from 28 weeks gestation to 38 weeks gestation)

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

  6. Birthweight

    Time frame: At birth (approximately 10 weeks after trial recruitment)

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

  7. Birth injury

    Time frame: At birth (approximately 10 weeks after trial recruitment)

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

  8. Neonatal hypoglycaemia

    Time frame: Approximately 10.5 weeks after recruitment

    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)

Other outcomes

  1. Economic evaluation

    Time frame: 11 weeks from trial recruitment

    Direct cost of clinical care provision including outpatient appointments, emergency presentations, inpatient admission nights, neonatal intensive and special care admission nights, cost of phone and blue tooth equipment, time spent on computer system by clinical staff, other associated treatment and obstetric management costs, costs associated with co-morbid conditions

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Acronym: TREAT-GDM

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2013
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.