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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Lipohypertrophy
• Intervention / Treatment: Behavioral: Optimal insulin injection

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation
    • State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB)
  • Moscow, Russian Federation, 117036
    • National Medical Research Center of Endocrinology (ENC)
  • Moscow, Russian Federation, 129110
    • Moscow Regional Research Clinical Institute (MONIKI)
  • Moscow, Russian Federation, 19034
    • Endocrinological Dispensary of the Moscow Department of Health (DZM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Optimal insulin injection; subjects receive training in optimal injection technique.

What is the study measuring?

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 theHbA1c% levels at Baseline and 6-months	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 the Total Units at Baseline, 3-months and 6-months follow up	up to 6 months
Incidence of Hypoglycemic Events	Incidence rate of hypoglycemic events in the 2-week period at study start (Baseline), a 2-week period approximately 3 months after Baseline, and during a 2 week period around 6 months follow up, expressed in per person-year	up to 6 months
Change in Blood Glucose Levels	Change in average Blood Glucose Levels (measured by a Blood Glucose Meter) 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 mmol/L	up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on Quality of Life	In the EQ-5D-35L the 5 dimensions are described by 3 problem levels corresponding to subject response choices. A quality of life score (Health State Index Score) is obtained according to the answers to the questionnaires. The scale runs from 0 to 1, higher scores mean a better quality of life. Quality of Life scores will be reported at Baseline and at 6 months;	up to 6 months
Change in Needle Re-use	Rate of needle re-use by self-reporting, expressed as number of participants reporting single-use needles at Baseline and after 3- and 6 months. Study participants were queried on their injection technique during study follow up visits and it was documented if they responded the use of a new needle for each insulin injection (single-use needles).	up to 6 months
Effect on Lipohypertrophy Areas	Sub-group: for subjects with lipohypertrophy areas at enrolment, change in lipohypertrophy size (length and width) from Baseline to 6 months At Baseline, lipohypertrophy areas caused by repeated insulin injections at the same injection location, were measured. These areas were measured again during the 3-month and 6-month follow up visits.	up to 6 months
Effect on Behaviour: Injection in Lipohypertrophy Areas	Sub-group: for subjects with lipohypertrophy areas at enrolment, change in injection into lipohypertrophy areas from Baseline to 6 months Study participants were queried on their injection technique during study baseline and follow up visits and it was documented if they responded if they inject insulin at a location with lipohypertrophy or at a different location for each injection (rotating).	up to 6 months

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Principal Investigator: Alexander Mayorov, MD, National Medical Research Center of Endocrinology (ENC)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: DBC-19INJCTRU; BD-4MM (Other Identifier: Becton Dickinson)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No