Clinical trial NCT01916694: Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus
Official title: A Randomised Pilot Trial to Compare Remote Blood Glucose Monitoring With Standard Clinical Care in the Gestational Diabetic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Pregnancy
Keywords: Gestational diabetes mellitus
m Health
Smartphone
Blood glucose monitoring
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 203
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Glycosylated haemogloblin
timeFrame: 8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation
Secondary outcomes:
measure: Mean Blood glucose levels for fasting, pre-prandial and post-prandial readings
timeFrame: 10 weeks (from 28 weeks gestation to 38 weeks gestation)
measure: Percentage of 'on target' blood glucose readings
timeFrame: 8 weeks (from recruitment at 28 weeks gestation to 36 weeks gestation)
measure: Effectiveness of monitoring
timeFrame: 10 weeks (from 28 weeks gestation to 38 weeks gestation)
measure: Maternal outcomes
timeFrame: Approximately 11 weeks after recruitment
measure: Maternal weight gain,
timeFrame: 10 weeks (from 28 weeks gestation to 38 weeks gestation)
measure: Birthweight
timeFrame: At birth (approximately 10 weeks after trial recruitment)
measure: Birth injury
timeFrame: At birth (approximately 10 weeks after trial recruitment)
measure: Neonatal hypoglycaemia
timeFrame: Approximately 10.5 weeks after recruitment
Other outcomes:
measure: Economic evaluation
timeFrame: 11 weeks from trial recruitment
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.