Diabetes in PregnancySugar TextNCT01973374
Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy
A study testing Text Message Intervention in people with Diabetes in Pregnancy and Gestational Diabetes, run by University of Pennsylvania at 1 site in United States.
Trial summary
Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can be minimized with tight glucose control. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Diabetes in Pregnancy, Gestational Diabetes, Texting Interventions
- What is being tested?
- Text Message Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18-50 years
- Planned delivery at Hospital of the University of Pennsylvania
Who cannot join
- Gestational age greater than 34 weeks at initial visit in the Penn Perinatal Diabetes Program
- Women who are unable to read English as all text messages will be in English
- Women who do not have a cellular phone capable of receiving text messages as this is the study intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can be minimized with tight glucose control. A number of studies in non-pregnant populations have highlighted the feasibility, acceptability and efficacy of text messaging interventions for improving diabetic compliance and control. This study will investigate whether a text messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and whether this intervention can improve compliance with diabetes care, glucose control and pregnancy outcomes. The study will also assess satisfaction with the intervention itself.
- Being tested
- Text Message Intervention
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Not described |
| Text Message Intervention | Experimental | The text message intervention group receives usual prenatal and diabetic care in addition to two text messages per week throughout the pregnancy and a reminder text message prior to the postpartum visit. The text message intervention group also fills out a survey about the intervention after delivery. Receives: Behavioral: Text Message Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction with the texting intervention as measured by a post-study survey
Measured: date of enrollment up to 12 weeks post partum
Compliance with Obstetric and Diabetes Care
Proportion of prenatal visits attended, proportion of assigned blood glucose logs sent to clinic for review, proportion of assigned blood glucose values checked, compliance with attendance at postpartum visit.
Measured: OB screening visit through 12 weeks postpartum
Secondary outcomes (4)
Efficacy measures
Measuring the proportion of blood glucose values within the target range each week; mean fasting and postprandial blood glucose values measured weekly; change in hemoglobin A1C (for pregestational diabetics) from initiation of care to the third trimester
Measured: Diabetes diagnosis through 12 weeks postpartum
Healthcare Utilization Measures
Measuring the number of visits to the perinatal evaluation center related to diabetes care and the total number of antepartum hospitalizations.
Measured: Screening OB visit through 12 weeks postpartum
Maternal Outcomes
Measuring the mode of delivery (spontaneous vaginal, operative vaginal, cesarean section), complications of delivery (shoulder dystocia, postpartum hemorrhage, third and fourth degree lacerations), and length of hospital stay.
Measured: Delivery date through 12 weeks postpartum
Neonatal Outcomes
Measuring fetal demise; neonatal death; birthweight; large for gestational age; small for gestational age; APGAR scores; umbilical cord blood gas; NICU admission; respiratory distress; hypoglycemia; hyperbilirubinemia; length of hospital stay
Measured: Neonate delivery through 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes in PregnancyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celeste Durnwald, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973374
- Sponsor's protocol ID
- 817181
- Acronym
- Sugar Text
- Status last verified
- Feb 2015
- First submitted
- 24 Oct 2013
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy
- ClinicalTrials.gov ID
- NCT01973374
- Acronym / sponsor ID
- Sugar Text / 817181
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can be minimized with tight glucose control. A number of studies in non-pregnant populations have highlighted the feasibility, acceptability and efficacy of text messaging interventions for improving diabetic compliance and control. This study will investigate whether a text messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and whether this intervention can improve compliance with diabetes care, glucose control and pregnancy outcomes. The study will also assess satisfaction with the intervention itself.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | – |
| Text Message Intervention | Experimental | Behavioral: Text Message InterventionThe text message intervention group receives usual prenatal and diabetic care in addition to two text messages per week throughout the pregnancy and a reminder text message prior to the postpartum visit. The text message intervention group also fills out a survey about the intervention after delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women aged 18-50 years
- Planned delivery at Hospital of the University of Pennsylvania
Key exclusion criteria (3 listed)
- Gestational age greater than 34 weeks at initial visit in the Penn Perinatal Diabetes Program
- Women who are unable to read English as all text messages will be in English
- Women who do not have a cellular phone capable of receiving text messages as this is the study intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Message Intervention | Behavioural | Text Message Intervention |
Primary outcome
Patient Satisfaction
Time frame: date of enrollment up to 12 weeks post partum
Patient satisfaction with the texting intervention as measured by a post-study survey
Compliance with Obstetric and Diabetes Care
Time frame: OB screening visit through 12 weeks postpartum
Proportion of prenatal visits attended, proportion of assigned blood glucose logs sent to clinic for review, proportion of assigned blood glucose values checked, compliance with attendance at postpartum visit.
4 secondary outcomes
Efficacy measures
Time frame: Diabetes diagnosis through 12 weeks postpartum
Healthcare Utilization Measures
Time frame: Screening OB visit through 12 weeks postpartum
Maternal Outcomes
Time frame: Delivery date through 12 weeks postpartum
Neonatal Outcomes
Time frame: Neonate delivery through 12 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message Intervention in people with Diabetes in Pregnancy and Gestational Diabetes, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: date of enrollment up to 12 weeks post partum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.