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

Not Applicable

Completed

• Conditions: Lipohypertrophy; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Interventions: Behavioral: Optimal insulin injection

• Registration Number: NCT04120974
• Lead Sponsor: Becton, Dickinson and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Primary Completion: 2021-04-26
• Study Completion: 2021-04-26
• Results First Submitted: 2022-01-20
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Results First Posted: 2024-02-22
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optimal insulin injection	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.

Primary Outcome Measures

Name	Time	Method
Change in Glycemic Control	up to 6 months	Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months

Secondary Outcome Measures

Name	Time	Method
Change in Insulin Total Daily Dose (TDD)	up to 6 months	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
Incidence of Hypoglycemic Events	up to 6 months	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
Change in Blood Glucose Levels	up to 6 months	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

Trial Locations

Locations (4)

State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB); 🇷🇺 Ekaterinburg, Russian Federation

National Medical Research Center of Endocrinology (ENC); 🇷🇺 Moscow, Russian Federation

Moscow Regional Research Clinical Institute (MONIKI); 🇷🇺 Moscow, Russian Federation

Endocrinological Dispensary of the Moscow Department of Health (DZM); 🇷🇺 Moscow, Russian Federation