The Role of Proper Insulin Injection Technique in the Treatment of Diabetes. Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Proper Insulin Injection Technique in the Treatment of Diabetes

Conditions
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Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Lipohypertrophy

Intervention / Treatment
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* Behavioral: Optimal insulin injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or type 2 diabetes mellitus; At least 1 year of experience with insulin self-administration; Use of insulin pen for insulin injections. HbA1c > 7.5 % measured at study entry or maximally 30 days prior to screening. BMI below 40 kg/m2 at study entry. Daily self-control of blood glucose level; Access to the internet for watching video lessons. Only outpatients are eligible for the study. Availability of signed informed consent of the patient for inclusion in the study. Exclusion Criteria: Pregnant women or women planning to become pregnant during the time of study, breastfeeding women; Subjects using an insulin pump; Those using treatment with a Glucagon-Like Peptide (GLP)-1 receptor agonists alone; Subjects not fluent in Russian (reading and writing). Patients at high risk for ketoacidosis and/or hyperglycemia. Psychic, physical or any other reasons hampering patient participation in the study (based on the reasonable opinion of the physician-investigator).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimal insulin injection<br>Study subjects will receive personal training from the Investigator on how to optimally inject insulin to treat their Diabetes Mellitus. In addition, each subject receives instruction how to use a web-based platform with online video training modules on optimal injection technique. | Behavioral: Optimal insulin injection<br>* subjects receive training in optimal injection technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycemic Control | Change in HbA1c for subjects from Baseline to 6 months; expressed as % change | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insulin Total Daily Dose (TDD) | Change in Insulin TDD for subjects from Baseline to 3 and 6 months; expressed as % change | up to 6 months | 
| Incidence of Hypoglycemic Events | Rate of hypoglycemic events and hypoglycemic events requiring third party assistance in the month prior to study start (Baseline) and during the 6 months of the study. | up to 6 months | 
| Change in Blood Glucose Levels | Change in average Blood Glucose Levels 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 % change | up to 6 months |