Objective
The main goal of the CKM-REACT study is to find out whether continuous ketone monitoring (CKM), paired with clear and structured education, helps children and teenagers with type 1 diabetes spend less time with high blood sugar and identify early warning signs of diabetic ketoacidosis (DKA) more effectively.
All participants will use the same investigational device that measures glucose and ketones continuously. The difference between study groups is what kind of education they receive—either in-person training, written materials only, or blinded data (control).
The study aims to understand whether simply having access to ketone data is helpful, or whether structured, hands-on training is necessary to turn this information into safer diabetes decisions.
Background Rationale
Children and adolescents with type 1 diabetes are at higher risk for diabetic ketoacidosis (DKA) than adults. DKA can develop quickly and is the leading cause of diabetes-related death in young people. Even with modern technology like automated insulin delivery (AID) systems, interruptions in insulin delivery or periods of metabolic stress—such as illness, sports, or high-fat meals—can lead to dangerous ketone buildup.
Traditional ketone testing is done only occasionally and usually after symptoms appear. This means families may miss early warning signs. Continuous ketone monitoring (CKM) offers a new way to spot ketone rises earlier, with a sensor providing readings every few minutes. However, little is known about how ketone levels behave throughout the day in young people or how families should interpret these values.
This study was designed because:
- No randomized trials have tested CKM in children with T1D.
- We do not yet know how common activities—like exercise or certain meals—affect ketone patterns in youth.
- Access to continuous ketone data alone may not be enough; families need structured education to understand what the numbers mean and how to act safely.
The CKM-REACT trial addresses these gaps directly.
Description of Project
Diabetic ketoacidosis (DKA) remains one of the most serious and life-threatening complications for children and teenagers with type 1 diabetes (T1D). Even with modern diabetes technology such as continuous glucose monitors (CGM) and automated insulin delivery (AID) systems, young people still experience DKA more often than adults. This happens because DKA can develop quickly when insulin delivery is interrupted, during illness, after missed insulin doses, or during times of added stress on the body - such as exercise or eating high-fat meals.
Traditionally, children and families have relied on occasional finger-stick or urine ketone checks, usually only done when someone feels unwell or sees repeatedly high glucose levels. These methods can miss early warning signs. New advances now make it possible to measure ketones continuously using a small wearable sensor, similar to a CGM. This technology - continuous ketone monitoring (CKM) - could help families detect problems earlier and prevent DKA.
However, having more data does not automatically mean better decisions. Families need clear guidance on how to interpret and act on ketone readings in real time. Little is currently known about how ketone levels behave during ordinary daily activities in children, such as sports, busy school days, sleep, or after high-fat meals. To date, no clinical trial has tested CKM in children with T1D.
The CKM-REACT study will fill this critical gap. The study will include 90 children and adolescents ages 8–18 who use AID systems. All participants will wear an investigational device that measures both glucose and ketones continuously. They will be randomly assigned to one of three groups:
Group A: CKM + structured, in-person education
Group B: CKM + written educational materials only
Group C: Blinded CKM (control group)
The goal is to understand whether CKM, especially when paired with hands-on education, helps young people spend less time with high blood sugar and reduces risky ketone elevations.
Participants will take part in real-world challenges known to affect glucose and ketone levels. These include weekly supervised exercise sessions and monthly high-fat meal challenges (such as pizza, pasta, or burgers). Data from these sessions will help researchers understand when ketone rises are normal and when they signal concern.
The study will also collect information about sleep, physical activity, body composition, and metabolic rate to understand how these factors might influence ketone responses.
If successful, the study will provide the first detailed picture of ketone behavior in young people with T1D and determine how CKM can be safely and effectively used to prevent DKA. This work has the potential to change future diabetes education, influence international guidelines, and improve everyday safety for children and families living with T1D.
Anticipated Outcome
We expect the CKM-REACT study to show whether continuous ketone monitoring, especially when combined with strong education, can help young people with T1D spend less time with high blood sugar and respond sooner to ketone elevations.
The study is also expected to:
- Show what types of education (in-person or written) best help families make safe, effective decisions when ketones rise.
- Provide the first detailed information on how ketones behave during exercise, meals, and overnight in children and teens using AID systems.
- Identify which ketone patterns are normal and which signal early risk.
- Improve understanding of how to prevent DKA before it starts.
If CKM helps families take earlier and safer action, it could improve daily diabetes management and reduce emergency visits and hospitalizations.
Relevance to T1D
DKA continues to be a major challenge in type 1 diabetes, especially for children and teenagers. Preventing DKA requires early identification of rising ketones before they reach dangerous levels. Continuous ketone monitoring could transform how families manage diabetes by providing earlier warning signals, just as continuous glucose monitoring transformed glucose management.
Because children often experience rapid metabolic changes, frequently participate in sports, and rely on caregivers, understanding ketone patterns in this age group is especially important. This study will provide critical evidence on whether CKM makes diabetes management safer and easier for families, and whether structured education is needed to support correct use of this new technology.
The results could directly shape future diabetes guidelines, improve safety practices, and help prevent life-threatening DKA episodes in young people with T1D.