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

Overview

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.

Full Title of Study: “The Role of Proper Insulin Injection Technique in the Treatment of Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2020

Interventions

  • Behavioral: Optimal insulin injection
    • subjects receive training in optimal injection technique.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Glycemic Control
    • Time Frame: up to 6 months
    • Change in HbA1c for subjects from Baseline to 6 months; expressed as % change

Secondary Measures

  • Change in Insulin Total Daily Dose (TDD)
    • Time Frame: up to 6 months
    • Change in Insulin TDD for subjects from Baseline to 3 and 6 months; expressed as % change
  • Incidence of Hypoglycemic Events
    • Time Frame: up to 6 months
    • 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.
  • Change in Blood Glucose Levels
    • Time Frame: up to 6 months
    • 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Becton, Dickinson and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexander Mayorov, MD, Principal Investigator, National Medical Research Center of Endocrinology (ENC)
  • Overall Contact(s)
    • Sandra van Guldener, MS, PMP, +31646900840, sandra.vanguldener@bd.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.