Status:
COMPLETED
The Role of Proper Insulin Injection Technique in the Treatment of Diabetes Mellitus
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-Fi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04120974
Start Date
October 1 2019
End Date
April 26 2021
Last Update
February 22 2024
Active Locations (4)
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1
National Medical Research Center of Endocrinology (ENC)
Moscow, Russia, 117036
2
Moscow Regional Research Clinical Institute (MONIKI)
Moscow, Russia, 129110
3
Endocrinological Dispensary of the Moscow Department of Health (DZM)
Moscow, Russia, 19034
4
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB)
Yekaterinburg, Russia