Clinical trial NCT04460092: Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Blood Glucose
Pain
leakage
insulin injections
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Plasma glucose
timeFrame: Up to 7 days
measure: Insulin leakage
timeFrame: Up to 7 days
measure: Pain when insulin injection
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mohammad Sadegh Bagheri Baghdasht
Study officials:
affiliation: Baqiyatallah Medical Sciences University
name: Esmail Heidaranlu
role: STUDY_CHAIR
References: