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

Baqiyatallah Medical Sciences University

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: 8-mm 32-gauge Insulin needles in the first three days of Intervention; Device: 5-mm 32-gauge Insulin needles in the last three days of Intervention; Device: 5-mm 32-gauge Insulin needles in the first three days of Intervention; Device: 8-mm 32-gauge Insulin needles in the last three days of Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04460092

IR.BMSU.BAQ.REC.1398.059

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Group "A"

Experimental group

Description:

In the first three days, participants in group "A" will inject 90-degree insulin injections using 5-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 8 mm to inject insulin.

Treatment:

Device: 5-mm 32-gauge Insulin needles in the first three days of Intervention

Device: 8-mm 32-gauge Insulin needles in the last three days of Intervention

Group"B"

Experimental group

Description:

In the first three days, participants in group "B" will inject 90-degree insulin injections using 8-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 5mm to inject insulin.

Treatment:

Device: 8-mm 32-gauge Insulin needles in the first three days of Intervention

Device: 5-mm 32-gauge Insulin needles in the last three days of Intervention