AiDAPT: Automated insulin Delivery Amongst Pregnant women with Type 1 Diabetes: A multicenter randomized controlled trial – study results.

Published Date:

05 October 2023

Published By:

Lee Et Al.

Approved By:

Prof. Helen R. Murphy MBBChBAO, MD, FRACP

Decoded By:

Asra H. Ahmed
 MBA, PGCE in Assessment Learning disability, Diabesties Foundation.

10 mins to read

  • The T1D Takeaway
  • The study shows that the use of the CamAPS FX automated insulin delivery system can help with effective blood sugar management during pregnancy. The CamAPS FX system offer a sense of control and security, crucial for maintaining maternal and baby’s health. Armed with this knowledge women can be empowered to ask for CamAPS FX technology to lessen the burden of managing glucose levels during pregnancy and enjoy the experience of having a baby.

Word Wizard

Automated closed loop Insulin delivery
Biomedical impact
Maternal glycaemia
Sensor augmented insulin pumps
  • This trial evaluated closed-loop insulin delivery was advantageous during pregnancy in a diverse group of participants across multiple sites with varying levels of experience in diabetes technology.
  • The hypothesis is that using closed-loop insulin delivery, as opposed to standard methods, can help pregnant women with type 1 diabetes reach target glucose levels during pregnancy.
  • The study gained insights into the experiences of both women and healthcare professionals using closed-loop systems and estimate the cost-effectiveness of this approach in managing type 1 diabetes during pregnancy.

Summary Snap
Shots

The study investigates how automated closed-loop insulin delivery benefits pregnant women with type 1 diabetes in managing glucose levels during pregnancy, despite facing challenges and using different diabetes technologies. Its aim is to reduce complications for both the mother and the baby by evaluating the effectiveness of this insulin delivery method.

Prime Insight

This trial aimed to evaluate how well automated closed-loop systems work in pregnant women with type 1 diabetes. They used a statistical model to see how much time these systems kept glucose levels within the target range from 16 weeks of pregnancy until delivery.

Results from studies in non-pregnant women but living with type1 diabetes suggested that all automated insulin delivery systems can safely improve glycemia before pregnancy, but that these systems may not all be applicable during pregnancy.

The AiDAPT study utilized the CamAPS FX hybrid closed-loop system, which runs the Cambridge model predictive control algorithm, which has a lower glucose target than other commercially available closed-loop systems. The system operated on an unlocked android smartphone, communicating via Bluetooth with the insulin pump (Dana Diabecare RS) and continuous glucose monitor (Dexcom G6).

The main objective is to monitor the duration spent within a targeted glucose range using continuous glucose monitoring from the 16th week of pregnancy until delivery.

Holistically, the study aims to evaluate the mother’s glucose regulation, obstetric and psychological outcomes, neonatal health, safety measures, the experiences of healthcare professionals, and economic considerations.

It also assessed whether closed loop influences the mother’s and newborn’s health outcomes. Women using CamAPS FX had significantly improved glucose levels from the first trimester and throughout pregnancy, with less weight gain (3.7 kg or 8.8lbs), and low rates of large birthweight babies

Individual patient data from this study was analyzed and four others to look at the effects on less common pregnancy outcomes like severe hypoglycemia and diabetic ketoacidosis events.

In conclusion, the closed-loop group had higher time in range 68.2% (±10.5), less time in hyperglycemia, more overnight time in range and lower HbA1C than those not on a CamAPS FX closed loop system.

The study gave us a better understanding of how women and healthcare professionals both benefitted from using closed-loop systems. It also estimated how useful these systems are during pregancy, which helped NICE to decide that that hybrid closed-loop (specifically CamAPS FX) should be offered in NHS healthcare settings in the future.

This was the largest randomized study to evaluate use of closed-loop insulin delivery throughout pregnancy. It will inform patients, caregivers, healthcare professionals and funding agencies regarding the use of CamAPS FX automated insulin delivery in pregnant populations living with type 1 diabetes.

Authors stated that the pregnancy benefits are specific to the CamAPS FX system and are not applicable to other commercially available closed-loop systems, with higher glucose targets.

  • A Deeper Dive
  • The Sources Voice

CamAPS FX hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes.

  • Curiosities Clarified

Yes, automated closed-loop insulin delivery has been shown to improve maternal glycemia during the second and third trimesters.

Automatic insulin delivery systems offer significant benefits for managing diabetes during pregnancy under the supervision of multiple medical team.

The automation and continuous monitoring aspect of closed-loop systems, which can reduce the burden of constant glucose monitoring and insulin dosing adjustments.

Determining the cost-effectiveness of automated closed-loop insulin delivery depends on various factors, including the specific context, healthcare system, and individual patient considerations.

 

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