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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / 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; 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

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Sadegh Bagheri Baghdasht; Phone Number: 0098 936 8214509; Email: hiasdasd0@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Mohammad Sadegh Bagheri Baghdasht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group "A"; 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.	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; Device: 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
Experimental: Group"B"; 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.	Device: 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; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose	Laboratory check the Plasma glucose according to the routine of the hospital units	Up to 7 days
Insulin leakage	The rate of insulin leakage after injection is observational	Up to 7 days
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

Collaborators and Investigators

• Sponsor: Baqiyatallah Medical Sciences University
• Investigators: Study Chair: Esmail Heidaranlu, Baqiyatallah University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Anticipated): June 29, 2020
• Study Completion (Anticipated): September 25, 2020

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: July 5, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Diabetes Mellitus, Type 2; Blood Glucose; leakage; insulin injections
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: IR.BMSU.BAQ.REC.1398.059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No