Clinical trial NCT04120974: The Role of Proper Insulin Injection Technique in the Treatment of Diabetes Mellitus
Official title: The Role of Proper Insulin Injection Technique in the Treatment of Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Lipohypertrophy
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in Glycemic Control
timeFrame: up to 6 months
Secondary outcomes:
measure: Change in Insulin Total Daily Dose (TDD)
timeFrame: up to 6 months
measure: Incidence of Hypoglycemic Events
timeFrame: up to 6 months
measure: Change in Blood Glucose Levels
timeFrame: up to 6 months
Other outcomes:
measure: Effect on Quality of Life
timeFrame: up to 6 months
measure: Change in Needle Re-use
timeFrame: up to 6 months
measure: Effect on Lipohypertrophy Areas
timeFrame: up to 6 months
measure: Effect on Behaviour: Injection in Lipohypertrophy Areas
timeFrame: up to 6 months
Locations:
city: Ekaterinburg
country: Russian Federation
facility: State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB)
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Endocrinology (ENC)
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute (MONIKI)
city: Moscow
country: Russian Federation
facility: Endocrinological Dispensary of the Moscow Department of Health (DZM)
Study officials:
affiliation: National Medical Research Center of Endocrinology (ENC)
name: Alexander Mayorov, MD
role: PRINCIPAL_INVESTIGATOR
References: