Simplified Meal Approach Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to examine whether a simplified meal approach (as compared to
      exact carbohydrate counting) can alleviate the need of carbohydrate counting without
      worsening postprandial control in youth and young adults with type 1 diabetes using hybrid
      closed-loop insulin delivery with the Cambridge Artificial Pancreas FX System (CamAPS FX
      system).
    

Detailed description: 
      Optimal glycaemic control is the aim of diabetes care and critical in the prevention of
      diabetes-related complications. Despite advances in diabetes technologies and medications,
      many current youth and young adults (YYA) with type 1 diabetes (T1D) are not meeting desired
      glycaemic targets, representing a missed opportunity for improving lifetime outcomes.

      A variety of factors including peer group influences, importance of body image, less parental
      oversight, greater risk-taking, and performance pressure challenge daily self-management in
      YYA with T1D. Disengagement from care and barriers for optimal glycaemic management in YYA
      have been mainly shown to be substantially influenced by perceived burden of daily tasks.

      Although the recently introduced closed-loop systems, which link insulin delivery to sensor
      glucose levels, offer promising opportunities to improve glucose control in YYA with T1D,
      they still require the user to estimate carbohydrates. The perceived burden of exact
      carbohydrate counting (ECC), the limited evidence supporting its glycaemic benefit and
      corrective potential of algorithm-driven background insulin titration question its necessity
      during hybrid-closed loop insulin treatment. Instead, a simplified meal approach (SMA), which
      only requires the user to select the meal carbohydrate category (small/medium/large), has the
      potential to alleviate the burden of ECC during hybrid closed-loop insulin therapy whilst
      resulting in similar glycaemic benefits.

      The investigators therefore hypothesize that a simplified meal approach (SMA) using the
      CamAPS FX system would achieve comparable glucose control compared with the use of the CamAPS
      FX system with ECC in YYA with T1D.
    

Intervention name(s): SMA bolus option; Exactly estimated carbohydrate content bolus option
Intervention type(s): Device; Device
Intervention description(s): SMA comprises the selection of predefined carbohydrate quantities for meal insulin dosing. Meal carbohydrate contents will be set on an individual basis at the baseline visit.; The carbohydrate content of meals is estimated in grams of carbohydrates prior to a meal bolus
Other intervention name(s): Simplified meal announcement bolus option
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Youth; Adolescents; Artificial pancreas system; Meal announcement