This is a prospective, post-marketing, single-arm clinical investigation on the effects of optimal insulin injection technique, in conjunction with the use of disposable Becton Dickinson (BD) Micro-Fine Plus 32G pen needles, by Type I and Type II Diabetes Mellitus patients, with or without lipohypertrophy, on clinical outcomes like HbA1c and hypoglycemic events, as well as changes in insulin Total Daily Dose (TDD) and patient's Quality of Life (QoL). During this study, each subject will be trained in the optimal insulin injection technique by personal training as well as by following online video training modules on a specific web-based platform.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
subjects receive training in optimal injection technique.
National Medical Research Center of Endocrinology (ENC)
Moscow, Russia
Moscow Regional Research Clinical Institute (MONIKI)
Moscow, Russia
Endocrinological Dispensary of the Moscow Department of Health (DZM)
Moscow, Russia
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB)
Yekaterinburg, Russia
Change in Glycemic Control
Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months
Time frame: up to 6 months
Change in Insulin Total Daily Dose (TDD)
Change in Insulin TDD for subjects from Baseline to 3 and 6 months; expressed as the Total Units at Baseline, 3-months and 6-months follow up
Time frame: up to 6 months
Incidence of Hypoglycemic Events
Incidence rate of hypoglycemic events in the 2-week period at study start (Baseline), a 2-week period approximately 3 months after Baseline, and during a 2 week period around 6 months follow up, expressed in per person-year
Time frame: up to 6 months
Change in Blood Glucose Levels
Change in average Blood Glucose Levels (measured by a Blood Glucose Meter) of the first 2 weeks after enrolment (Baseline), compared to the average Blood Glucose Levels during 2 weeks around 3 month and the average of 2 weeks Blood Glucose Levels around 6 months; expressed as mmol/L
Time frame: up to 6 months
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