Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BD-4MM | Other Identifier | Becton Dickinson |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimal insulin injection | Behavioral | subjects receive training in optimal injection technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of Hypoglycemic Events |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Mayorov, MD | National Medical Research Center of Endocrinology (ENC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Center of Endocrinology (ENC) | Moscow | 117036 | Russia | |||
| Moscow Regional Research Clinical Institute (MONIKI) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Optimal Insulin Injection Technique | Patients with Type I or Type II Diabetes Mellitus with an HbA1c value >7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only the participants who completed the study have been analyzed and are reported on. 90 Participants included, but 82 completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Optimal Insulin Injection Technique | Patients with Type I or Type II Diabetes Mellitus with an HbA1c value >7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycemic Control | Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months | Only participants who completed the study have been analyzed | Posted | Mean | Standard Deviation | % of glycated hemoglobin | up to 6 months |
|
|
Adverse Events were collected from study enrollment until End of Study (between Baseline and approximately 6-months follow up)
Adverse Event collection was systematically collected by study site staff during on-site and telephone follow-up visits. A Clinical Research Associate has conducted a 100% source data verification and reviewed patient medical charts to ensure all Adverse Events were captured in the Case Report Forms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Optimal Insulin Injection Technique | Patients with Type I or Type II Diabetes Mellitus with an HbA1c value >7.5% and at least 1 year experience with insulin self-administration were enrolled in this study. Patients were re-trained in the correct technique of insulin injection and received access to video training modules. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment | COVID-19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual impairment | Eye disorders | MedDRA 23.1 | Systematic Assessment | Vision problem induced by Diabetes Mellitus |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra van Guldener, Director OUS Clinical Affairs | Becton, Dickinson and Company | +31646900840 | sandra.vanguldener@bd.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2019 | Dec 28, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2021 | Dec 28, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Moscow |
| 129110 |
| Russia |
| Endocrinological Dispensary of the Moscow Department of Health (DZM) | Moscow | 19034 | Russia |
| State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB) | Yekaterinburg | Russia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI, average | Mean | Standard Deviation | kg/m^2 |
|
| Baseline HbA1c (%), average | Mean | Standard Deviation | % of glycated hemoglobin |
|
| Diabetes Type: Type I, Type II | Count of Participants | Participants |
|
| Insulin therapy duration, average (years) | Mean | Standard Deviation | years |
|
| Baseline Lipohypertrophy: Yes, No | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | units | 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 | Data are expressed as overall (all participants) and split per type of Diabetes (Type I or Type II) | Posted | Number | events 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 | Not all participants had BGM data available, this is the reason the number of analyzed participants deviates from the total number analyzed in the study. | Posted | Mean | Standard Deviation | mmol/L | up to 6 months |
|
|
|
| Other Pre-specified | 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; | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Other Pre-specified | 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). | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| Other Pre-specified | 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. | Only participants with lipohypertrophy at Baseline were included in this analysis | Posted | Geometric Mean | Standard Deviation | cm | up to 6 months |
|
|
|
| Other Pre-specified | 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). | Only participants with lipohypertrophy at Baseline were included in this analysis | Posted | Count of Participants | Participants | up to 6 months |
|
|
|
| 1 |
| 90 |
| 4 |
| 90 |
| 5 |
| 90 |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment | COVID-19 and bilateral polysegmental pneumonia due to COVID-19. |
|
| Death | General disorders | MedDRA 23.1 | Systematic Assessment | The cause is not clear, the statement in the documents mentions "other unspecified causes of death". |
|
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment | Planned hospitalization for coronography due to coronary heart disease. |
|
|
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment | Foot ulcer and necessity to wear foot cast |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Acute respiratory infection - rhinopharyngitis |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Acute respiratory viral infection (clinically COVID-19 was probable, but was not confirmed) |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
|
| Incidence of hypoglycemic events at 6-months follow up (overall) |
|
|
| Incidence of hypoglycemic events at Baseline (Type I DM) |
|
|
| Incidence of hypoglycemic events at 3-months follow up (Type I DM) |
|
|
| Incidence of hypoglycemic events at 6-months follow up (Type I DM) |
|
|
| Incidence of hypoglycemic events at Baseline (Type II DM) |
|
|
| Incidence of hypoglycemic events at 3-months follow up (Type II DM) |
|
|
| Incidence of hypoglycemic events at 6-months follow-up (Type II DM) |
|
|
|
| 24-hour blood glucose average during a two-week period at 6-months follow up |
|
|
| Title | Measurements |
|---|---|
|
|
| Width lipohypertrophy area at Baseline |
|
| Width lipohypertrophy area at 3-months follow up |
|
| Width lipohypertrophy area at 6-months follow up |
|
|