- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01916694
Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus (TREAT-GDM)
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.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oxfordshire
-
Oxford, Oxfordshire, United Kingdom, OX3 9DU
- John Radcliffe Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Smart phone app glucose monitoring
Home blood glucose monitoring results directly transmitted via a bluetooth enabled smart phone app to a central database to be reviewed by clinicians
|
Fingerprick testing of blood glucose levels before and 2 hours after meals
|
Active Comparator: Standard glucose monitoring
Home blood glucose monitoring results recorded by hand in a paper diary by the patient and reviewed by the clinical team in the outpatient clinic.
|
Fingerprick testing of blood glucose levels before and 2 hours after meals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
10 weeks (from 28 weeks gestation to 38 weeks gestation)
|
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
|
8 weeks (from recruitment at 28 weeks gestation to 36 weeks gestation)
|
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
|
10 weeks (from 28 weeks gestation to 38 weeks gestation)
|
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)
|
Approximately 11 weeks after recruitment
|
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
|
10 weeks (from 28 weeks gestation to 38 weeks gestation)
|
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
|
At birth (approximately 10 weeks after trial recruitment)
|
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
|
At birth (approximately 10 weeks after trial recruitment)
|
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)
|
Approximately 10.5 weeks after recruitment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
11 weeks from trial recruitment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/SC/0176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
University Hospital, ToursCompleted
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Universitair Ziekenhuis BrusselMerck Serono International SAUnknownPregnancy | Pregnancy LossBelgium
-
Turku University HospitalUniversity of TurkuCompleted
-
Hopital Antoine BeclereUnknown
Clinical Trials on Blue tooth enabled glucose meter with smart phone application
-
Vicente Lorenzo-Zúñiga GarcíaCompletedMobile Applications | Cathartics