NCT04120974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 22, 2024

Completed
Last Updated

February 22, 2024

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

October 4, 2019

Results QC Date

January 20, 2022

Last Update Submit

July 18, 2023

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Lipohypertrophy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Insulin Total Daily Dose (TDD)

    up to 6 months

  • Incidence of Hypoglycemic Events

    up to 6 months

  • Change in Blood Glucose Levels

    up to 6 months

Other Outcomes (4)

  • Effect on Quality of Life

    up to 6 months

  • Change in Needle Re-use

    up to 6 months

  • Effect on Lipohypertrophy Areas

    up to 6 months

  • +1 more other outcomes

Study Arms (1)

Optimal insulin injection

EXPERIMENTAL

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

Interventions

Optimal insulin injectionBEHAVIORAL

subjects receive training in optimal injection technique.

Optimal insulin injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or type 2 diabetes mellitus;
  • At least 1 year of experience with insulin self-administration;
  • Use of insulin pen for insulin injections.
  • HbA1c \> 7.5 % measured at study entry or maximally 30 days prior to screening.
  • BMI below 40 kg/m2 at study entry.
  • Daily self-control of blood glucose level;
  • Access to the internet for watching video lessons.
  • Only outpatients are eligible for the study.

You may not qualify if:

  • Pregnant women or women planning to become pregnant during the time of study, breastfeeding women;
  • Subjects using an insulin pump;
  • Those using treatment with a Glucagon-Like Peptide (GLP)-1 receptor agonists alone;
  • Subjects not fluent in Russian (reading and writing).
  • Patients at high risk for ketoacidosis and/or hyperglycemia.
  • Psychic, physical or any other reasons hampering patient participation in the study (based on the reasonable opinion of the physician-investigator).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Medical Research Center of Endocrinology (ENC)

Moscow, 117036, Russia

Location

Moscow Regional Research Clinical Institute (MONIKI)

Moscow, 129110, Russia

Location

Endocrinological Dispensary of the Moscow Department of Health (DZM)

Moscow, 19034, Russia

Location

State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB)

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Sandra van Guldener, Director OUS Clinical Affairs
Organization
Becton, Dickinson and Company
sandra.vanguldener@bd.com
+31646900840

Study Officials

  • Alexander Mayorov, MD

    National Medical Research Center of Endocrinology (ENC)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 9, 2019

Study Start

October 1, 2019

Primary Completion

April 26, 2021

Study Completion

April 26, 2021

Last Updated

February 22, 2024

Results First Posted

February 22, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(4)