Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effect of Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose Control in Type - II Diabetic Patients in Baqiyatollah Hospital and Clinic, Tehran, 2019 -2020

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460092
• Other study ID #: IR.BMSU.BAQ.REC.1398.059
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: July 2020
• Source: Baqiyatallah Medical Sciences University
• Contact: Mohammad Sadegh Bagheri Baghdasht
• Phone: 0098 936 8214509
• Email: hiasdasd0[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.

Description:

This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.

After entering the data in SPSS20 software, the collected data will be analyzed using descriptive statistics (frequency, percentage, mean, standard deviation) and statistical tests (t-test, chi-square).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 25, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Having type II diabetes

• Use injectable insulin for at least two years

• BMI >18

• Lack of mental illness and mental retardation

• Use insulin pen

Exclusion Criteria:

• Lack of desire to participate in the study

• Having a skin problem in the injection site

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• 5-mm 32-gauge Insulin needles in the first three days of Intervention
32-gauge needles with a length of 5mm to inject insulin in first three days
• 8-mm 32-gauge Insulin needles in the first three days of Intervention
32-gauge needles with a length of 8mm to inject insulin in first three days
• 5-mm 32-gauge Insulin needles in the last three days of Intervention
32-gauge needles with a length of 5mm to inject insulin in second three days
• 8-mm 32-gauge Insulin needles in the last three days of Intervention
32-gauge needles with a length of 8mm to inject insulin in second three days

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mohammad Sadegh Bagheri Baghdasht	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glucose	Laboratory check the Plasma glucose according to the routine of the hospital units	Up to 7 days
Primary	Insulin leakage	The rate of insulin leakage after injection is observational	Up to 7 days
Primary	Pain when insulin injection	Survey severity pain when insulin injection by Visual Analogue Scale (VAS). This is a numerical scale that tells the patient the severity of their pain from one to ten. The larger the number, the more pain there is.	Up to 7 days