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

Not Applicable

Completed

• Conditions: Type 1 and Type 2 diabetes; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN12263696
• Lead Sponsor: Moscow Regional Research and Clinical Institute

Brief Summary

2017 Results article in https://pubmed.ncbi.nlm.nih.gov/29027634/ (added 15/02/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-01-01
• Study Start: 2017-03-20
• Last Update Posted: 1 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Blood glucose control is measured using the A1C test at baseline and 6 months<br> 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<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 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<br>