Use of reminders to support women with prior gestational diabetes on decision making on participation in screening for type 2 diabetes after birth
| ISRCTN | ISRCTN23558707 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23558707 |
| Secondary identifying numbers | 310599 |
- Submission date
- 21/04/2022
- Registration date
- 22/04/2022
- Last edited
- 24/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Women with pregnancy complicated by gestational diabetes are at an increased risk of developing type 2 diabetes later in life. These women are therefore urged to participate in life-long screening in general practice, 2-3 months after birth and every year, or a minimum of every third year after birth. The use of electronic reminders to women have been used to strengthen the insufficient participation found in follow-up screening. However, there are great variations in the effect of the reminders and reminder interventions which include a long-term perspective have not previous been investigated. The aim of this study is to determine the effectiveness of an electronic reminder intervention for women 1- 8 years after pregnancy complicated by gestational diabetes in increasing uptake in the recommended follow-up screening in general practice.
Who can participate?
Women of childbearing age who have had a pregnancy complicated by gestational diabetes.
What does the study involve?
Participants are randomly allocated into either an intervention group or a control group. Within each group the women are stratified by the year of birth of the child where the pregnancy was complicated by gestational diabetes (2012-2018). The reminder is sent out once to the intervention group through a national secured mailbox which all citizens in Denmark have and follow-ups are performed 6 months after. Usual care, which both groups received, includes information before discharge from hospital on the increased risk and recommendations on follow-up screening after birth and women have the responsibility for booking appointments for screening. Outcomes measured include screening tests performed and type 2 diabetes diagnosis.
What are the possible benefits and risks of participating?
Benefits for participants include being provided with information to support decision making on participation in the recommended screening after birth as well as the potential of early detection of type 2 diabetes. No direct risks of participating are expected as no women are deprived of the opportunity to participate in screening. However, a feeling of increased stress and fear caused by risk communication could possibly occur for some women.
Where is the study run from?
University College of Northern Denmark (Denmark)
When is the study starting and for how long is it expected to run for?
January 2019 to May 2021
Who is funding the study?
1. University College of Northern Denmark (Denmark)
2. Aalborg University (Denmark)
3. Aalborg University Hospital (Denmark)
Who is the main contact?
Jane Hyldgaard Nielsen
jhy@ucn.dk, jhy@hst.aau.dk
Contact information
Scientific
Selma lagerløfs vej 2
Aalborg Øst
9200
Denmark
 ORCID ID |
0000-0003-2815-3984 |
|---|---|
| Phone | +45 (0)28896104 |
| jhy@ucn.dk |
Study information
| Study design | Two-armed single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Reminders to support early detection of type 2 diabetes: a randomized controlled trial comparing the use of electronic reminders for screening after birth to usual care for women with previous gestational diabetes |
| Study acronym | RemGDM |
| Study objectives | Reminders increase uptake in follow-up screening more than usual care where women with previous gestational diabetes (GDM) do not receive a reminder |
| Ethics approval(s) | On 17/01/2019 the Science Ethics Committee for the North Denmark Region (Niels Bohrs Vej 30, 9220 Aalborg Ø, Denmark; +45 (0)97 64 84 40; vek@rn.dk) was asked if ethical approval was needed. It was decided that the project did not require ethical approval. This was based on the following reasoning: "none of the participants will be deprived of the opportunity for a screening examination". |
| Health condition(s) or problem(s) studied | Early detection of type 2 diabetes among women with previous gestational diabetes |
| Intervention | A two-armed, single-blinded randomized controlled trial, where women are allocated to either the intervention group (usual care + reminder) or the control group (usual care). Within each group the women are stratified by the year of birth of the child where the pregnancy was complicated by gestational diabetes (2012-2018). The randomization is performed within each strata using R Core Team (2020) and carried out using a computer-generated random allocation sequence to create a 1:1 ratio. The reminder is sent out once through a national secured mailbox which all citizens in Denmark have and a follow-up is performed 6 months after. |
| Intervention type | Behavioural |
| Primary outcome measure | Participation in follow-up screening, defined as the performance of blood test for diabetes and measured through Danish National Registry Data 6 months after the reminder was sent out |
| Secondary outcome measures | Women diagnosed with type 2 diabetes measured through Danish National Registry Data 6 months after the reminder was sent out |
| Overall study start date | 01/01/2019 |
| Completion date | 01/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1708 |
| Total final enrolment | 1708 |
| Key inclusion criteria | Women of childbearing age and with previous pregnancy complicated by gestational diabetes |
| Key exclusion criteria | 1. Women with another diabetes diagnosis than GDM prior to birth 2. women with another diabetes diagnosis than GDM during/after pregnancy 3. Women who died 4. Women who no longer lived in the North Denmark Region |
| Date of first enrolment | 27/08/2020 |
| Date of final enrolment | 01/02/2021 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Denmark
Sponsor information
University/education
Selmalagerløfs vej 2
Aalborg Øst
9200
Denmark
| Phone | +45 (0)72690975 |
|---|---|
| GTC@ucn.dk | |
| Website | http://www.ucnorth.dk/Default.aspx |
"ROR" |
https://ror.org/056c4z730 |
Funders
Funder type
University/education
No information available
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Aalborg University, AAU
- Location
- Denmark
Government organisation / Local government
- Alternative name(s)
- Aalborg University Hospital
- Location
- Denmark
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | According to ethical or legal restrictions, the researchers are not able to make data available for the public. This project is based solely on already obtained registry-based data. All data were pseudonymized and consent from participants was according to Danish legislation not required. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/01/2023 | 24/01/2023 | Yes | No |
Editorial Notes
24/01/2023: Publication reference added.
28/06/2022: The intention to publish date was changed from 01/05/2022 to 01/12/2022.
22/04/2022: Trial's existence confirmed by Aalborg University Hospital.
