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

NCT04120974 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-02-22

Study results available
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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-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.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
  • Lipohypertrophy

Interventions

BEHAVIORAL

Optimal insulin injection

subjects receive training in optimal injection technique.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Alexander Mayorov, MD · National Medical Research Center of Endocrinology (ENC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-04-26
Completion
2021-04-26

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120974 on ClinicalTrials.gov