Study design and participants
hypoglycemic, ketoacidosis, ®, diabetes
DIABETES, EVENTS, TYPE 1 DIABETES, KETOACIDOSIS
This is a randomized controlled study, open-label, parallel arms, among adult persons with type 1 diabetes (Eligible participants were persons with type 1 diabetes who visited the outpatient clinic in Hospital Comarcal de l’Alt Penedès between January 2021 and June 2021. Inclusion criteria were persons over 18 years with type 1 diabetes of at least 6 months duration, with internet access mobile phone, and trained to use the SocialDiabetes® App. All participants were receiving multiple daily injections of insulin therapy. For participants with the FGM system, 2 months of use was required before randomization. The exclusion criteria were severe ketoacidosis in the previous 3 months, severe or recurrent hypoglycemic events, need for diabetes education support, or lack of consent to participate.The required sample size for bilateral contrast was estimated using an α value of 0.05, a β value of 0.2 and a common standard deviation for HbA1c of 0.6% (4.2 mmol/mol) to detect a difference in HbA1c ≥ 0.5% (3.1 mmol/mol) and taking into account a dropout rate of 10%, 27 participants per arm would be needed.