Diabetes Mellitus, Type 2NCT04120974
The Role of Proper Insulin Injection Technique in the Treatment of Diabetes Mellitus
A study testing Optimal insulin injection in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company at 4 sites in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Lipohypertrophy
- What is being tested?
- Optimal insulin injection
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesRussia
- Study dates
- 1 Oct 2019to 26 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
National Medical Research Center of Endocrinology (ENC)
Moscow, 117036
Moscow Regional Research Clinical Institute (MONIKI)
Moscow, 129110
Endocrinological Dispensary of the Moscow Department of Health (DZM)
Moscow, 19034
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB)
Yekaterinburg
About this study
Official title: The Role of Proper Insulin Injection Technique in the Treatment of Diabetes
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.
- Being tested
- Optimal insulin injection
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal insulin injectionBehavioural
subjects receive training in optimal injection technique.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Optimal insulin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycemic Control
Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months
Measured: up to 6 months
Secondary outcomes (3)
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
Measured: up to 6 months
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
Measured: up to 6 months
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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Oct 2019
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Mayorov, MD, Principal investigator, National Medical Research Center of Endocrinology (ENC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120974
- Sponsor's protocol ID
- DBC-19INJCTRU
- Other IDs
- BD-4MM
- Status last verified
- Jul 2023
- First submitted
- 4 Oct 2019
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Proper Insulin Injection Technique in the Treatment of Diabetes
- ClinicalTrials.gov ID
- NCT04120974
- Acronym / sponsor ID
- DBC-19INJCTRU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimal insulin injection | Experimental | Behavioral: Optimal insulin injectionStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal insulin injectionsubjects receive training in optimal injection technique. | Behavioural | Optimal insulin injection |
Primary outcome
Change in Glycemic Control
Time frame: up to 6 months
Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months
3 secondary outcomes
Change in Insulin Total Daily Dose (TDD)
Time frame: up to 6 months
Incidence of Hypoglycemic Events
Time frame: up to 6 months
Change in Blood Glucose Levels
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Mayorov, MD principal investigator
National Medical Research Center of Endocrinology (ENC)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal insulin injection in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company at 4 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycemic Control (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.