Automated Insulin Delivery for Pregnancy in Type 1 Diabetes
(COSCLIP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how automated insulin delivery (AID) systems affect pregnant people with type 1 diabetes (T1D). Researchers seek to compare health outcomes for both the mother and baby, as well as changes in blood sugar levels and emotional well-being, between those using commercial AID systems and those using open-source (DIY or hacked) systems. Participants must share their AID system data, complete surveys, and allow access to their medical records. This trial suits those who are pregnant, have T1D diagnosed before pregnancy, and use an AID system.
As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve care for pregnant individuals with T1D.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study focuses on the use of automated insulin delivery systems, it seems likely that you can continue using your current insulin regimen.
What prior data suggests that these automated insulin delivery systems are safe for pregnant individuals with type 1 diabetes?
Previous studies have shown that commercially available automated insulin delivery (AID) systems are generally well-tolerated by pregnant women with type 1 diabetes. Research indicates that these systems effectively manage blood sugar levels, leading to better health outcomes for both mothers and their babies. Serious side effects are rare, though some users might experience mild issues like skin irritation from the device.
For open-source AID systems, also known as do-it-yourself or hacked systems, studies have found improved blood sugar control as well. Users have reported spending more time with their blood sugar in a healthy range and less time with it being too low, which is crucial during pregnancy. However, limited data exists on their safety specifically for pregnant users. While many have used these systems successfully, less formal research supports their safety.
Both types of AID systems appear promising for managing type 1 diabetes during pregnancy. However, as with any medical device, monitoring for side effects and consulting healthcare providers regularly is important.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it compares two intriguing approaches for managing type 1 diabetes in pregnant individuals. The trial examines both commercial and open source automated insulin delivery (AID) systems. Unlike traditional insulin pumps and manual monitoring, these systems automatically adjust insulin levels in real-time, which could offer more precise glycemic control. The open source AID systems, often referred to as do-it-yourself or hacked systems, allow for more customization and potentially quicker updates based on community-driven advancements. By evaluating these options, the trial aims to uncover which system provides better outcomes during pregnancy, a period when maintaining stable blood sugar levels is crucial.
What evidence suggests that this trial's AID systems could be effective for pregnant individuals with type 1 diabetes?
This trial will compare two types of automated insulin delivery (AID) systems for pregnant individuals with type 1 diabetes. Studies have shown that commercial AID systems help maintain blood sugar levels within a healthy range, reducing episodes of high blood sugar. Participants in this trial may use commercial AID systems. Open-source AID systems, another option in this trial, also show promise; studies have noted improved blood sugar control and successful diabetes management during pregnancy. Both types of AID systems appear effective in helping pregnant individuals with diabetes maintain healthier blood sugar levels.24678
Who Is on the Research Team?
Nasim Sobhani, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observational Study
Participants use automated insulin delivery (AID) systems and share data remotely, complete online surveys, and authorize access to medical records
Follow-up
Participants are monitored for maternal, neonatal, glycemic, behavioral, and emotional outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Commercial AID system
- Open Source AID system
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Pregnant individuals with type 1 diabetes T1D) using open source automated insulin delivery (AID) systems (also known as do-it-yourself AID systems or hacked AID systems) for glycemic management in pregnancy
Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Citations
Automated insulin delivery in pregnant women with type 1 ...
AID systems effectively improve glycaemic control during pregnancy in women with T1DM by increasing TIR and reducing hyperglycaemia.
Automated Insulin Delivery in Women with Pregnancy ...
Hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes.
Use of advanced technology for the treatment of type 1 ...
Automated insulin delivery (AID) systems have led to a paradigm shift for the management of type 1 diabetes outside pregnancy.
4.
diabetesjournals.org
diabetesjournals.org/spectrum/article/38/3/217/163136/Automated-Insulin-Delivery-for-Type-1-DiabetesAutomated Insulin Delivery for Type 1 Diabetes: Present and ...
Advancements in automated insulin delivery (AID) systems have transformed type 1 diabetes management, making AID the most effective ...
Treatment of Type 1 Diabetes Mellitus During Pregnancy ...
Women using the AID system achieved significantly better glycaemic control, spending on average 14 percentage points more TIR compared to the SAP group. The AID ...
Use of a Commercially Available Automated Insulin ...
This retrospective descriptive cohort study was conducted to evaluate maternal, neonatal, and glycemic outcomes in gravidas with T1D who utilized the Omnipod 5 ...
A review of automated insulin delivery use in type 1 ...
Some randomized controlled trials have observed better glycemic outcomes in pregnant patients with type 1 diabetes who used automated insulin ...
Automated insulin delivery in pregnant women with type 1 ...
In this systematic review and meta-analysis, we aimed to assess the efficacy and safety of AID systems in pregnant women with T1DM. The findings ...
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