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

NCT ID: NCT04120974

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-04-26

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-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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimal insulin injection

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.

Group Type: EXPERIMENTAL

Optimal insulin injection

Intervention Type: BEHAVIORAL

subjects receive training in optimal injection technique.

Interventions

Optimal insulin injection

subjects receive training in optimal injection technique.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Type 1 or type 2 diabetes mellitus;

2. At least 1 year of experience with insulin self-administration;

3. Use of insulin pen for insulin injections.

4. HbA1c > 7.5 % measured at study entry or maximally 30 days prior to screening.

5. BMI below 40 kg/m2 at study entry.

6. Daily self-control of blood glucose level;

7. Access to the internet for watching video lessons.

8. Only outpatients are eligible for the study.

9. Availability of signed informed consent of the patient for inclusion in the study.

Exclusion Criteria

1. Pregnant women or women planning to become pregnant during the time of study, breastfeeding women;

2. Subjects using an insulin pump;

3. Those using treatment with a Glucagon-Like Peptide (GLP)-1 receptor agonists alone;

4. Subjects not fluent in Russian (reading and writing).

5. Patients at high risk for ketoacidosis and/or hyperglycemia.

6. Psychic, physical or any other reasons hampering patient participation in the study (based on the reasonable opinion of the physician-investigator).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Mayorov, MD

Role: PRINCIPAL_INVESTIGATOR

National Medical Research Center of Endocrinology (ENC)

Locations

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

Countries

Russia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BD-4MM

Identifier Type: OTHER

Identifier Source: secondary_id

DBC-19INJCTRU

Identifier Type: -

Identifier Source: org_study_id