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

NCT04460092 | Unknown DMC

• 1 other identifier: IR.BMSU.BAQ.REC.1398.059
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Blood Glucose; Pain; leakage; insulin injections

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group "A"

EXPERIMENTAL

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

Group"B"

EXPERIMENTAL

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

Interventions

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

32-gauge needles with a length of 5mm to inject insulin in first three days

Group "A"

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

32-gauge needles with a length of 8mm to inject insulin in first three days

Group"B"

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

32-gauge needles with a length of 5mm to inject insulin in second three days

Group"B"

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

32-gauge needles with a length of 8mm to inject insulin in second three days

Group "A"

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having type II diabetes
• Use injectable insulin for at least two years
• BMI \>18
• Lack of mental illness and mental retardation
• Use insulin pen

You may not qualify if:

• Lack of desire to participate in the study
• Having a skin problem in the injection site

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead

Study Sites (1)

Mohammad Sadegh Bagheri Baghdasht

Tehran, 0, Iran

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Esmail Heidaranlu

  Baqiyatallah Medical Sciences University

  STUDY CHAIR

Central Study Contacts

Mohammad Sadegh Bagheri Baghdasht

CONTACT

0098 936 8214509; hiasdasd0@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: July 7, 2020
• Study Start: May 25, 2020
• Primary Completion: June 29, 2020
• Study Completion: September 25, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

IR (1)