search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Lipohypertrophy

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Optimal insulin injection
Sponsored by
Becton, Dickinson and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optimal insulin injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Glycemic Control
Change in HbA1c for subjects from Baseline to 6 months; expressed as % change

Secondary Outcome Measures

Change in Insulin Total Daily Dose (TDD)
Change in Insulin TDD for subjects from Baseline to 3 and 6 months; expressed as % change
Incidence of Hypoglycemic Events
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
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

Full Information

First Posted
October 4, 2019
Last Updated
April 30, 2021
Sponsor
Becton, Dickinson and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT04120974
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 26, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Becton, Dickinson and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Lipohypertrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal insulin injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Optimal insulin injection
Intervention Description
subjects receive training in optimal injection technique.
Primary Outcome Measure Information:
Title
Change in Glycemic Control
Description
Change in HbA1c for subjects from Baseline to 6 months; expressed as % change
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Change in Insulin Total Daily Dose (TDD)
Description
Change in Insulin TDD for subjects from Baseline to 3 and 6 months; expressed as % change
Time Frame
up to 6 months
Title
Incidence of Hypoglycemic Events
Description
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.
Time Frame
up to 6 months
Title
Change in Blood Glucose Levels
Description
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
Time Frame
up to 6 months
Other Pre-specified Outcome Measures:
Title
Effect on Quality of Life
Description
In the EQ-5D-35L the 5 dimensions are described by 3 problem levels corresponding to subject response choices. A quality of life score is obtained according to the answers to the questionnaires. In this study an assessment will be done if there is a change in Quality of Life score, from Baseline to 6 months;
Time Frame
up to 6 months
Title
Change in needle re-use
Description
Rate of needle re-use by self-reporting at Baseline and after 3- and 6 months
Time Frame
up to 6 months
Title
Effect on lipohypertrophy areas
Description
Sub-group: for subjects with lipohypertrophy areas at enrolment, change in lipohypertrophy size (length and width) from Baseline to 6 months; expressed in % change
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Availability of signed informed consent of the patient for inclusion in the study. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Mayorov, MD
Organizational Affiliation
National Medical Research Center of Endocrinology (ENC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB)
City
Ekaterinburg
Country
Russian Federation
Facility Name
National Medical Research Center of Endocrinology (ENC)
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Moscow Regional Research Clinical Institute (MONIKI)
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Endocrinological Dispensary of the Moscow Department of Health (DZM)
City
Moscow
ZIP/Postal Code
19034
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs