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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120974
• Other study ID #: DBC-19INJCTRU
• Secondary ID: BD-4MM
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 26, 2021

Study information

• Verified date: July 2023
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Optimal insulin injection
subjects receive training in optimal injection technique.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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