Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus

Pregnancy Clinical Trial

— TREAT-GDM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916694
• Other study ID #: 13/SC/0176
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: May 19, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Oxford University Hospitals National Health Service (NHS) TrustUnited Kingdom: Thames Valley Comprehensive Local Research NetworkUnited Kingdom: University of Oxford
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Pregnancy

Intervention

Device:
• Blue tooth enabled glucose meter with smart phone application

Behavioral:
• Self home blood glucose monitoring
Fingerprick testing of blood glucose levels before and 2 hours after meals

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic evaluation	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	11 weeks from trial recruitment	No
Primary	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).	8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation	No
Secondary	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).	10 weeks (from 28 weeks gestation to 38 weeks gestation)	No
Secondary	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	8 weeks (from recruitment at 28 weeks gestation to 36 weeks gestation)	No
Secondary	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	10 weeks (from 28 weeks gestation to 38 weeks gestation)	No
Secondary	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)	Approximately 11 weeks after recruitment	No
Secondary	Maternal weight gain,	Weight gain in kilograms from trial recruitment until last antenatal visit prior to delivery	10 weeks (from 28 weeks gestation to 38 weeks gestation)	No
Secondary	Birthweight	Z score of weight in kilograms for gestational age at delivery and Birthweight greater than 4.5kg	At birth (approximately 10 weeks after trial recruitment)	No
Secondary	Birth injury	Fracture of clavicle or humerus or other injury attributed to difficult birth, such as Erbs palsy or skull fracture	At birth (approximately 10 weeks after trial recruitment)	No
Secondary	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)	Approximately 10.5 weeks after recruitment	No