Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000621819
Ethics application status
Approved
Date submitted
31/05/2012
Date registered
8/06/2012
Date last updated
21/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
DIAMIND: Diabetes SMS text reminders for women who have had gestational diabetes mellitus to test for type 2 diabetes or impaired glucose tolerance in the postpartum period
Scientific title
Diabetes SMS text reminders versus standard care for women who have had gestational diabetes mellitus to increase the rate of oral glucose tolerance testing in the postpartum period
Secondary ID [1] 280501 0
Not applicable
Universal Trial Number (UTN)
Not applicable
Trial acronym
DIAMIND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes 286479 0
Condition category
Condition code
Reproductive Health and Childbirth 286737 286737 0 0
Childbirth and postnatal care
Metabolic and Endocrine 286738 286738 0 0
Diabetes
Public Health 286873 286873 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group = 6 week reminder.

The intervention will consist of text message reminders sent to the participant's phone at 6 weeks postpartum, with a subsequent reminder at 3 months and 6 months if the participant does not report having undertaken an oral glucose tolerance test. The text messages will include the participant's first name, but will otherwise be generic. The text message will remind the participant that it is time for them to have an oral glucose tolerance test to see whether they have type 2 diabetes or impaired glucose tolerance. We also ask the participants to let us know when they have had the test, and the results of the test, although this part of the text message is for data collection purposes only.
Intervention code [1] 284866 0
Early detection / Screening
Comparator / control treatment
Control group = 6 month reminder.

The women in the control group will receive a text message reminder at 6 months postpartum to have their oral glucose tolerance test.

As with the 6 week group, the text message will remind the participant that it is time for them to have an oral glucose tolerance test to see whether they have type 2 diabetes or impaired glucose tolerance. We also ask the participants to let us know when they have had the test, and the results of the test, although this part of the text message is for data collection purposes only.

The study's primary outcome is whether or not an OGTT was undertaken by 6 months, so this 6 month reminder will not influence the primary outcome.

Note: The National Gestational Diabetes Register (NDSS Australia) sends out a reminder letter at 12-16 weeks after the expected due date, and women in both intervention and control groups may sign up to this register.
Control group
Active

Outcomes
Primary outcome [1] 287133 0
Whether oral glucose tolerance testing has been undertaken by six months postpartum.

Details:
To determine whether or not oral glucose tolerance testing has been undertaken by 6 months postpartum, three main methods of data collection will be utilised:

(1) asking participants to let us know whether they have had an OGTT in the initial text message
(2) asking participants whether they have had an OGTT in the 6 month postpartum follow up questionnaire
(3) checking the clinical information system in the hospital to see whether an OGTT has been done

Further data collection methods may be considered if data collection is not adequately complete using these methods alone.
Timepoint [1] 287133 0
Six months postpartum
Secondary outcome [1] 297469 0
Proportion of women having other blood glucose tests.

Details:
The "other blood glucose tests" are glycated haemoglobin (HbA1c) and fasting plasma glucose. This data will be collected only via the 6 month follow up questionnaire.
Timepoint [1] 297469 0
Six months postpartum
Secondary outcome [2] 297470 0
Comparison of potentially influential factors between responders and non responders in the intervention group.

Details:
These factors have been selected as a result of literature review and careful consideration.

Trial entry weight and height will be measured for BMI calculation.
Some additional baseline characteristics and data relating to gestational diabetes will be asked verbally at recruitment. Maternal and neonatal outcomes relating to gestational diabetes will be collected from medical records. Finally, the 6 month postpartum questionnaire asks some questions regarding both current and past lifestyle as an indicator of tendency to adhere to health-related recommendations.
Timepoint [2] 297470 0
Various
Secondary outcome [3] 297471 0
Test results from OGTT (where applicable)

Details: OGTT test results will be collected via multiple methods to ensure data collection is as complete as possible:
(1) asking participants to provide their results in initial text message
(2) asking participants to provide their results in the 6 month postpartum follow up questionnaire
(3) checking the clinical information system in the hospital for results
Timepoint [3] 297471 0
From six weeks to six months postpartum
Secondary outcome [4] 297472 0
Preferred reminder system.

Details: Women will be asked in the 6 month follow up questionnaire what their preferred mode of reminder system is (postal, email, text, voice call).
Timepoint [4] 297472 0
Six months postpartum
Secondary outcome [5] 297473 0
Cost of text reminders.

Details: Text message credits have been purchased at a set cost and the number of text messages sent will be recorded for both the intervention and control groups.
Timepoint [5] 297473 0
At completion of trial

Eligibility
Key inclusion criteria
(a) Diagnosed with GDM in this pregnancy
(b) Access to a mobile phone
(c) Postnatal blood glucose level returned to normal before discharge
(d) Singleton or twin pregnancy
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Known (pre-existing) type 1 or type 2 diabetes mellitus
(b) Interpreter required
(c) Stillbirth

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be undertaken using the
telephone randomisation service located at ARCH (Australian Research Centre for the Health of Women and Babies). This service will use a randomisation schedule with balanced variable blocks, prepared by a researcher not involved with recruitment or clinical care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated by computer random numbers and stratified by severity of GDM (e.g. whether or not insulin was required during pregnancy).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/06/2012
Actual
22/06/2012
Date of last participant enrolment
Anticipated
Actual
20/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
252
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285282 0
University
Name [1] 285282 0
Australian Research Centre for Health of Women and Babies, The Robinson Institute, The University of Adelaide.
Country [1] 285282 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road, North Adelaide, South Australia, 5006.
Country
Australia
Secondary sponsor category [1] 284142 0
Hospital
Name [1] 284142 0
Women's and Children's Hospital
Address [1] 284142 0
72 King William Road, North Adelaide, South Australia, 5006
Country [1] 284142 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287277 0
The Women's and Children's Health Network (WCHN) Human Research Ethics Committee
Ethics committee address [1] 287277 0
Ethics committee country [1] 287277 0
Australia
Date submitted for ethics approval [1] 287277 0
Approval date [1] 287277 0
Ethics approval number [1] 287277 0
REC2200/8/12

Summary
Brief summary
Gestational diabetes is a form of diabetes, or glucose intolerance, that develops during pregnancy. Women who have had gestational diabetes are many times more likely to develop type 2 diabetes in the future compared with women who have normal blood glucose levels during pregnancy. Thus, it is important to screen these women after they have given birth to see whether they have type 2 diabetes, such that it can be treated, or to see whether they are on the way to developing type 2 diabetes (have impaired glucose tolerance), such that preventative changes can be made.

The best way of detecting type 2 diabetes and impaired glucose tolerance is with an oral glucose tolerance test, and this test is recommended by many health organisations, such as the Australasian Diabetes in Pregnancy Society, to be undertaken in the early postpartum period. Despite this, evidence shows that many women who have had gestational diabetes do not receive this follow up testing.

The DIAMIND study is aiming to test whether a text message based reminder system (using mobile phone technology) will increase the number of women who have had gestational diabetes who undertake oral glucose tolerance testing in the postpartum period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34185 0
Dr Emer Heatley
Address 34185 0
University of Adelaide Discipline of Obstetrics and Gynaecology Women's and Children's Hospital 72 King William Road, North Adelaide South Australia 5006
Country 34185 0
Australia
Phone 34185 0
+610883131369
Fax 34185 0
Email 34185 0
[email protected]
Contact person for public queries
Name 17432 0
Dr Emer Heatley
Address 17432 0
University of Adelaide
Discipline of Obstetrics and Gynaecology
Women's and Children's Hospital
72 King William Road,
North Adelaide
South Australia 5006
Country 17432 0
Australia
Phone 17432 0
+610883131369
Fax 17432 0
+610881617652
Email 17432 0
[email protected]
Contact person for scientific queries
Name 8360 0
Ms Philippa Middleton
Address 8360 0
University of Adelaide
Discipline of Obstetrics and Gynaecology
Women's and Children's Hospital
72 King William Road,
North Adelaide
South Australia 5006
Country 8360 0
Australia
Phone 8360 0
+610881617612
Fax 8360 0
+610881617652
Email 8360 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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