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Completed

NCT Number: NCT04120974

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Lipohypertrophy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinological Dispensary of the Moscow Department of Health (DZM), Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Optimal insulin injection

Behavioral

subjects receive training in optimal injection technique.

Primary outcomes

  1. 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

Secondary outcomes

  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 the Total Units at Baseline, 3-months and 6-months follow up

  2. Incidence of Hypoglycemic Events

    Time frame: up to 6 months

    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

  3. Change in Blood Glucose Levels

    Time frame: up to 6 months

    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

Other outcomes

  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 (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;

  2. Change in Needle Re-use

    Time frame: up to 6 months

    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).

  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 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.

  4. Effect on Behaviour: Injection in Lipohypertrophy Areas

    Time frame: up to 6 months

    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).

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2019
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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