CHEO Led Research:
coaching in Type 1 Diabetes Study:
decision making (SDM) is a model of health decision making where a patient,
their family, and healthcare professionals (HCPs) exchange information,
including the patient’s/family's values and preferences and the best available
evidence, then deliberate together before making a shared decision. Youth with type 1 diabetes and their parents
face many preference-sensitive decisions where the right choice depends on
integrating the best available evidence with what matters most to the youth and
family. This study evaluates the effect
of decision coaching and patient decision aids in reducing decisional conflict
and helping youth and their families make the best decision related to their
insulin delivery method. It is part of a
larger implementation and evaluation project led by Family Decision Services.
CGM TIME Trial:
Technology is rapidly changing and developing, and can be used to help people manage their diabetes. Insulin pump therapy and glucose sensors (also called Continuous Glucose Monitoring or CGM) are two of these devices. The glucose sensor uses a small piece of tubing which is inserted under the skin, just like the insulin pump. CGM provides sugar readings every 5 minutes (up to 288 sugars per day) and can improve diabetes control, with a reduction in low and high blood sugar levels.
The CGM TIME Trial is a multi-centered trial studying if starting a glucose sensor at the same time as an insulin pump results in more frequent sensor use and whether this improves the patient’s diabetes control, compared to delaying glucose sensor start until 6 months after the patient starts on an insulin pump.
Continuous Glucose Monitoring (CGM) provides a blood glucose reading every 5 minutes for up to 288 blood glucose levels per day. The real-time CGM data also includes “trend arrows” which indicate when blood glucose levels are rapidly falling or rising, allowing the insulin pump user to make immediate adjustments to insulin delivery to prevent consequent low or high blood sugars. Currently we don’t know the best way to react to trend arrows, therefore this study looks to compare 2 different ways to respond to these arrows. The JDRF CGM Study Group recommends that boluses be adjusted using a 10-20% increase/decrease of the original bolus dose (10% for one arrow up or down, and 20% for two arrows up or down), with the original bolus dose calculated by the pump calculator (e.g., Bolus Wizard). However, this formula, could potentially over compensate for trend arrows (e.g. if eating a large carbohydrate meal, a 20% adjustment could be several units of insulin) with a potential for low/high sugars after the meal.
CHEO’s CGM TIME Trial Study Group developed a different method for adjusting boluses for trend arrows called the Trend Arrow Adjustment Tool (TAAT), which is based on the patient’s insulin sensitivity factor (ISF). The purpose of the TAAT Study is to provide scientific evidence on the effectiveness of the Trend Arrow Adjustment Tool and to compare it to the 10/20% adjustment method.
Dr. Lawson and her study team have completed the study using Medtronic Devices and hope to repeat the study using Animas Devices so that all Pump and CGM users benefit from the results of the study.
Little is known about the effects of Decision Aids (DA) to inform preference-sensitive decisions related to participation in clinical trials. DAs used during participant recruitment for trials may improve the potential participants’ understanding of the information provided and help them to clarify their values and preferences in deciding whether to participate in the research study. The role of DAs in the consenting process for clinical trials has not yet been examined within the pediatric populations. The DEAR study is evaluating the effect of a DA compared to the traditional consent form (CF) on decisional conflict, knowledge and choice about hypothetical trial participation.
Type 1 Diabetes TrialNet (TrailNet) Studies:TrialNet is an international network of researchers who are exploring ways to prevent, delay and reserve the progression of type 1 diabetes. https://www.diabetestrailnet.org/ Here at CHEO we partake in 3 TrialNet Studies:
- The Natural History Study: is an international study which screens and observes relatives of people with type 1 diabetes to learn more about who develops diabetes and how.
- The Oral Insulin Study: is an international study which tests whether a daily oral insulin capsule can prevent or delay the disease in at-risk relatives of people with type 1 diabetes.
- LIFT Study: is an international study which monitors the progress of children and youth who have developed type 1 diabetes.