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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue tooth enabled glucose meter with smart phone application | Device |
| ||
| Self home blood glucose monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29559428 | Derived | 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. | |
| 26988348 |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Behavioral |
Fingerprick testing of blood glucose levels before and 2 hours after meals |
|
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
| 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) |
| 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 |
| 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. |
| 25361643 | 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |