Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus

NCT ID: NCT01916694

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-02-29

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.

Conditions

Gestational Diabetes Mellitus; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Blue tooth enabled glucose meter with smart phone application

Intervention Type: DEVICE

Self home blood glucose monitoring

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Self home blood glucose monitoring

Intervention Type: BEHAVIORAL

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

Interventions

Blue tooth enabled glucose meter with smart phone application

Intervention Type: DEVICE

Self home blood glucose monitoring

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29559428 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26988348 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25361643 (View on PubMed)

Other Identifiers

13/SC/0176

Identifier Type: -

Identifier Source: org_study_id