Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus

NCT01916694 | Completed DMC

• 1 other identifier: 13/SC/0176
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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

Keywords

Gestational diabetes mellitus; m Health; Smartphone; Blood glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

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

  10 weeks (from 28 weeks gestation to 38 weeks gestation)

• Percentage of 'on target' blood glucose readings

  8 weeks (from recruitment at 28 weeks gestation to 36 weeks gestation)

• Effectiveness of monitoring

  10 weeks (from 28 weeks gestation to 38 weeks gestation)

• Maternal outcomes

  Approximately 11 weeks after recruitment

• Maternal weight gain,

  10 weeks (from 28 weeks gestation to 38 weeks gestation)

Other Outcomes (1)

• Economic evaluation

  11 weeks from trial recruitment

Study Arms (2)

Smart phone app glucose monitoring

EXPERIMENTAL

Home blood glucose monitoring results directly transmitted via a bluetooth enabled smart phone app to a central database to be reviewed by clinicians

Device: Blue tooth enabled glucose meter with smart phone application; Behavioral: Self home blood glucose monitoring

Standard glucose monitoring

ACTIVE COMPARATOR

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.

Behavioral: Self home blood glucose monitoring

Interventions

Blue tooth enabled glucose meter with smart phone application DEVICE

Smart phone app glucose monitoring

Self home blood glucose monitoring BEHAVIORAL

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

Smart phone app glucose monitoring; Standard glucose monitoring

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 29559428 DERIVED

• 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.

  PMID: 26988348 DERIVED

• 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.

  PMID: 25361643 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: August 6, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

GB (1)