Type 1 DiabetesNCT04278664
Telemedicine in Pregnant Women With Type 1 Diabetes Mellitus
An observational study of Type 1 Diabetes and Pregnancy in Diabetic, run by Ana Braescu.
Trial summary
Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 1 Diabetes, Pregnancy in Diabetic
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Nov 2017
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Maternal glycemic control in Type I Diabetics during pregnancy will be studied by enrolling patients in two different groups: one will be treated with the current standard of care for a type 1 diabetic pregnancy and the other group will receive the same standard of care in addition to utilizing telemedicine communication of glucose and insulin readings during weeks when there are no recommended physician visits. All participants will be monitored throughout their pregnancy and clinical outcomes will be reviewed upon delivery and a 6-week postpartum visit. This study is important in adding to current literature regarding the role of telemedicine in pregnant type 1 diabetic care as it could potentially lead to changes in the current standard care for pregnant type 1 diabetics.
Who may be able to join
- type 1 diabetics who are at or less than 16 weeks in their pregnancy
- 18 years of age or more
- Voluntary participation
Who cannot join
- <18 years of age
- Not Type I diabetic
About this study
Official title: Effect of Telemedicine on Outcomes in Pregnant Women With Type 1 Diabetes Mellitus
Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered clinical questions and areas for improvement in regard to standards of care for pregnant type 1 diabetics. The data generated from this analysis will help determine whether telemedicine can be an effective additional means of care for pregnant type 1 diabetic patients.
Read the detailed description
Few studies have researched the use of telemedicine in the management of type 1 diabetes during pregnancy. These studies are additionally limited due to the number of patients as well as several secondary outcomes reported. Therefore, this study will enroll 100 participants to reach a power of 81.8% with HbA1c as a primary outcome and secondary outcomes related to diabetic management such as frequency of hypoglycemia, antenatal hospital stay (percentage requiring admission, length of stay), miscarriage, cesarean section rates, induction of labor, fetal birth weight, gestational age at birth or preterm birth (<34 weeks, <37 weeks), frequency of neonatal hypoglycemia, shoulder dystocia, neonatal death, major and minor anomalies, and neonatal intensive care admission.
- Conditions
- Type 1 Diabetes, Pregnancy in Diabetic
- Keywords
- telemedicine, Type 1 diabetes in pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 1, Pregnancy in Diabetics
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, maternal glycemic control
maternal glycemic control during pregnancy as measured by HbA1c
Measured: first trimester in pregnancy through 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startJul 2015
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Braescu
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Sponsor-investigator, Ana Braescu, Pediatrix
- Investigators
- C. Kevin Huls, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278664
- Sponsor's protocol ID
- 1506903391 UA IRB#
- Status last verified
- Aug 2022
- First submitted
- 18 Feb 2020
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telemedicine on Outcomes in Pregnant Women With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04278664
- Acronym / sponsor ID
- 1506903391 UA IRB#
- Conditions
- Type 1 Diabetes, Pregnancy in Diabetic
- Keywords
- telemedicine, Type 1 diabetes in pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ana BraescuUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 20 Feb 2020 (actual)
- 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.
Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered clinical questions and areas for improvement in regard to standards of care for pregnant type 1 diabetics. The data generated from this analysis will help determine whether telemedicine can be an effective additional means of care for pregnant type 1 diabetic patients.
Detailed description
Few studies have researched the use of telemedicine in the management of type 1 diabetes during pregnancy. These studies are additionally limited due to the number of patients as well as several secondary outcomes reported. Therefore, this study will enroll 100 participants to reach a power of 81.8% with HbA1c as a primary outcome and secondary outcomes related to diabetic management such as frequency of hypoglycemia, antenatal hospital stay (percentage requiring admission, length of stay), miscarriage, cesarean section rates, induction of labor, fetal birth weight, gestational age at birth or preterm birth (<34 weeks, <37 weeks), frequency of neonatal hypoglycemia, shoulder dystocia, neonatal death, major and minor anomalies, and neonatal intensive care admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Maternal glycemic control in Type I Diabetics during pregnancy will be studied by enrolling patients in two different groups: one will be treated with the current standard of care for a type 1 diabetic pregnancy and the other group will receive the same standard of care in addition to utilizing telemedicine communication of glucose and insulin readings during weeks when there are no recommended physician visits. All participants will be monitored throughout their pregnancy and clinical outcomes will be reviewed upon delivery and a 6-week postpartum visit. This study is important in adding to current literature regarding the role of telemedicine in pregnant type 1 diabetic care as it could potentially lead to changes in the current standard care for pregnant type 1 diabetics.
Key inclusion criteria (3 listed)
- type 1 diabetics who are at or less than 16 weeks in their pregnancy
- 18 years of age or more
- Voluntary participation
Key exclusion criteria (2 listed)
- <18 years of age
- Not Type I diabetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c, maternal glycemic control
Time frame: first trimester in pregnancy through 6 weeks postpartum
maternal glycemic control during pregnancy as measured by HbA1c
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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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.
C. Kevin Huls, MD principal investigator
Pediatrix
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Pregnancy in Diabetic, run by Ana Braescu.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: low enrollment). Results are not available in the source record.
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?
HbA1c, maternal glycemic control (time frame: first trimester in pregnancy through 6 weeks postpartum). 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 30 Aug 2022.