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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120974
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Lipohypertrophy Behavioral: Optimal insulin injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Proper Insulin Injection Technique in the Treatment of Diabetes
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Optimal insulin injection
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
subjects receive training in optimal injection technique.




Primary Outcome Measures :
  1. Change in Glycemic Control [ Time Frame: up to 6 months ]
    Change in HbA1c for subjects from Baseline to 6 months; expressed as % change


Secondary Outcome Measures :
  1. Change in Insulin Total Daily Dose (TDD) [ Time Frame: up to 6 months ]
    Change in Insulin TDD for subjects from Baseline to 3 and 6 months; expressed as % change

  2. Incidence of Hypoglycemic Events [ Time Frame: up to 6 months ]
    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.

  3. Change in Blood Glucose Levels [ Time Frame: up to 6 months ]
    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


Other Outcome Measures:
  1. Effect on Quality of Life [ Time Frame: up to 6 months ]

    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;


  2. Change in needle re-use [ Time Frame: up to 6 months ]
    Rate of needle re-use by self-reporting at Baseline and after 3- and 6 months

  3. Effect on lipohypertrophy areas [ Time Frame: up to 6 months ]
    Sub-group: for subjects with lipohypertrophy areas at enrolment, change in lipohypertrophy size (length and width) from Baseline to 6 months; expressed in % change



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120974


Contacts
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Contact: Sandra van Guldener, MS, PMP +31646900840 sandra.vanguldener@bd.com
Contact: Evgenia Voronova +79857942314 evgenia.voronova@bd.com

Locations
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Russian Federation
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital No. 1" (EKB) Not yet recruiting
Ekaterinburg, Russian Federation
Contact: Anna Malishevskaya, MD         
Principal Investigator: Anna Malishevskaya, MD         
National Medical Research Center of Endocrinology (ENC) Recruiting
Moscow, Russian Federation, 117036
Contact: Alexander Mayorov, MD         
Principal Investigator: Alexander Mayorov, MD         
Sub-Investigator: Olga Melnikova, MD         
Russian Medical Academy of Continuing Professional Education (RMANPO) Not yet recruiting
Moscow, Russian Federation, 125315
Contact: Alexander Ametov, MD         
Principal Investigator: Alexander Ametov, MD         
Sub-Investigator: Natalia Chernikova, MD         
Moscow Regional Research Clinical Institute (MONIKI) Active, not recruiting
Moscow, Russian Federation, 129110
Endocrinological Dispensary of the Moscow Department of Health (DZM) Active, not recruiting
Moscow, Russian Federation, 19034
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
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Principal Investigator: Alexander Mayorov, MD National Medical Research Center of Endocrinology (ENC)

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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT04120974    
Other Study ID Numbers: DBC-19INJCTRU
BD-4MM ( Other Identifier: Becton Dickinson )
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs