Pregnancy Data Repository to Assess Management of Type 1 Diabetes with Diabetes Technology (PRAM-T1D)
C
Christina M. Scifres, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
25 participants needed
7 Locations
Brief description of study
What is the purpose of this study?
The study is being done because we want to learn more about how people with type 1 diabetes in the United States manage their diabetes during pregnancy. We will enroll pregnant individuals with type 1 diabetes to participate in the PRAM-T1D registry, which will collect information on glucose levels, insulin treatment, and how this relates to pregnancy outcomes. The goal of this study is to learn things that may help people with type 1 diabetes who are pregnant in the future. We hope that this study will help us learn more about what makes living with diabetes during pregnancy easier.
The study is being done because we want to learn more about how people with type 1 diabetes in the United States manage their diabetes during pregnancy. We will enroll pregnant individuals with type 1 diabetes to participate in the PRAM-T1D registry, which will collect information on glucose levels, insulin treatment, and how this relates to pregnancy outcomes. The goal of this study is to learn things that may help people with type 1 diabetes who are pregnant in the future. We hope that this study will help us learn more about what makes living with diabetes during pregnancy easier.
THIS STUDY IS ENROLLING BY INVITATION ONLY - We will refer pregnant individuals with type 1 diabetes to participate in the PRAM-T1D registry, which will collect information on glucose levels, insulin treatment, and how this relates to pregnancy outcomes; this will involve providing information about PRAM-T1D and directing patients to the PRAM-T1D website where they can enroll themselves. IU investigators will have IU patients who are enrolled in PRAM-T1D and selected for specified data outcomes sign an authorization that will allow us to send medical records information to the main study team at Jaeb.
Detailed description of study
What will happen during the study?
- Participants will be asked to be in this research study throughout their pregnancy and for a few months after their delivery.
- Study participation will involve answering sets of questions online.
- Participants will be asked to share data from their diabetes care devices (e.g. a continuous glucose monitor (CGM) or insulin delivery device (insulin pump).
- Participants will also be asked to share their personal medical records and some information from their baby’s medical records.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 1 Diabetes, Pregnant, Pregnancy
-
Age: 18 years - 100 years
-
Gender: All
Inclusion criteria:
• be less than 15 weeks pregnant (We will ask you some questions to help you figure out if you are less than 15 weeks pregnant if you decide you want to join the study.)
• have had type 1 diabetes for at least 6 months and use insulin daily (take at least 2 injections of insulin per day or use an insulin pump)
o If you take multiple daily injections of insulin, you must be willing to share information about your insulin use.
o If you use an insulin pump, you must be able to share the data from your pump.
• be planning to use a continuous glucose monitor (CGM) regularly throughout the study
• be willing and able to provide informed consent, answer survey questions online, and share your diabetes care device data
• be living in the United States for the whole time you are in the study
Exclusion criteria:
• be pregnant with more than one baby (twins, triplets, etc.)
• be on renal (kidney) dialysis
• have a history of liver cirrhosis (permanent scarring that damages your liver)
• be receiving systemic chemotherapy for cancer (treatment with an anticancer drug that travels through the blood to destroy cancerous cells throughout the body). Treatment could be through a pill, injection, or an intravenous infusion.
• be participating in or planning to participate in another research study where you are using an investigational insulin delivery device during your pregnancy
• have previously participated in this study during a prior pregnancy
• be less than 15 weeks pregnant (We will ask you some questions to help you figure out if you are less than 15 weeks pregnant if you decide you want to join the study.)
• have had type 1 diabetes for at least 6 months and use insulin daily (take at least 2 injections of insulin per day or use an insulin pump)
o If you take multiple daily injections of insulin, you must be willing to share information about your insulin use.
o If you use an insulin pump, you must be able to share the data from your pump.
• be planning to use a continuous glucose monitor (CGM) regularly throughout the study
• be willing and able to provide informed consent, answer survey questions online, and share your diabetes care device data
• be living in the United States for the whole time you are in the study
Exclusion criteria:
• be pregnant with more than one baby (twins, triplets, etc.)
• be on renal (kidney) dialysis
• have a history of liver cirrhosis (permanent scarring that damages your liver)
• be receiving systemic chemotherapy for cancer (treatment with an anticancer drug that travels through the blood to destroy cancerous cells throughout the body). Treatment could be through a pill, injection, or an intravenous infusion.
• be participating in or planning to participate in another research study where you are using an investigational insulin delivery device during your pregnancy
• have previously participated in this study during a prior pregnancy
Updated on
13 Feb 2025.
Study ID: OBGYN-JAEB-PRAM-T1D, 24274
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