Studying the effect of the correct insulin injection technique training and single use of needles for insulin pens on the control of blood glucose and daily dose of injected insulin in diabetic patients receiving multiple insulin injections

A randomized controlled trial to assess the impact of proper insulin injection technique training on glycemic control

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12263696

Enrollment

120

Registered

2017-03-20

Start date

2013-07-01

Completion date

Unknown

Last updated

2022-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 and Type 2 diabetes Nutritional, Metabolic, Endocrine Diabetes

Interventions

Participants are randomised to one of three groups using a table with random numbers generated by Statistika software. Group 1: Patients with type 1 or 2 DM receiving multiple injecti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of T1DM or T2DM 2. Aged 18 to 70 years 3. On multiple dose injection therapy (3 injections of prandial and 1 to 2 injections of basal insulin daily, prescribed as a pen injection and initiated at least 1 month before study entry) 4. Deemed ready to strictly adhere to the study protocol and scheduled physician visits 5. Provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Presence of skin and soft tissue infections at the area of insulin injection 2. History of psychiatric disorders, mental deficiency, or language barrier that could adversely affect interactions with the treating physician in terms of achieving study objectives

Design outcomes

Primary

Measure	Time frame
1. Blood glucose control is measured using the A1C test at baseline and 6 months 2. Fasting plasma glucose (FPG) is measured using the HemoCue® Glucose 201+ point-of-care glucometer (HemoCue AB, Angelholm, Sweden) at baseline and 6 months	—

Secondary

Measure	Time frame
1. Proportion of patients with A1C >9% is determined by A1C test performed using DCA Vantage Analyzer (Siemens Healthcare Diagnostics Inc., Malvern, PA, USA) at 6 months 2. Changes in insulin total daily dose (TDD), the frequency of needle reuse, and length of needle used before and after training is assessed by the investigator at study visits 1 and 6 3. Injection-related adverse events (AEs) are assessed by the investigator at each clinic visit. Visual examination and palpation of insulin injection sites to reveal LH and/or bruising was performed at baseline and the final study visit; patients were also questioned on the frequency of injection-related pain and bruising during these visits	—

Measure

Time frame

1. Proportion of patients with A1C >9% is determined by A1C test performed using DCA Vantage Analyzer (Siemens Healthcare Diagnostics Inc., Malvern, PA, USA) at 6 months 2. Changes in insulin total daily dose (TDD), the frequency of needle reuse, and length of needle used before and after training is assessed by the investigator at study visits 1 and 6 3. Injection-related adverse events (AEs) are assessed by the investigator at each clinic visit. Visual examination and palpation of insulin injection sites to reveal LH and/or bruising was performed at baseline and the final study visit; patients were also questioned on the frequency of injection-related pain and bruising during these visits

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Countries

Russian Federation

Contacts

Public ContactInna V. Misnikova

inna-misnikova@mail.ru+7 495 688 95 93

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026