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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
5-mm 32-gauge Insulin needles in the first three days of Intervention
8-mm 32-gauge Insulin needles in the first three days of Intervention
5-mm 32-gauge Insulin needles in the last three days of Intervention
8-mm 32-gauge Insulin needles in the last three days of Intervention
Sponsored by
Baqiyatallah Medical Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Blood Glucose, Pain, leakage, insulin injections

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mohammad Sadegh Bagheri BaghdashtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group "A"

Group"B"

Arm 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.

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.

Outcomes

Primary Outcome Measures

Plasma glucose
Laboratory check the Plasma glucose according to the routine of the hospital units
Insulin leakage
The rate of insulin leakage after injection is observational
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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2020
Last Updated
July 5, 2020
Sponsor
Baqiyatallah Medical Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04460092
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
June 29, 2020 (Anticipated)
Study Completion Date
September 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baqiyatallah Medical Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Blood Glucose, Pain, leakage, insulin injections

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group "A"
Arm Type
Experimental
Arm 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.
Arm Title
Group"B"
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
5-mm 32-gauge Insulin needles in the first three days of Intervention
Intervention Description
32-gauge needles with a length of 5mm to inject insulin in first three days
Intervention Type
Device
Intervention Name(s)
8-mm 32-gauge Insulin needles in the first three days of Intervention
Intervention Description
32-gauge needles with a length of 8mm to inject insulin in first three days
Intervention Type
Device
Intervention Name(s)
5-mm 32-gauge Insulin needles in the last three days of Intervention
Intervention Description
32-gauge needles with a length of 5mm to inject insulin in second three days
Intervention Type
Device
Intervention Name(s)
8-mm 32-gauge Insulin needles in the last three days of Intervention
Intervention Description
32-gauge needles with a length of 8mm to inject insulin in second three days
Primary Outcome Measure Information:
Title
Plasma glucose
Description
Laboratory check the Plasma glucose according to the routine of the hospital units
Time Frame
Up to 7 days
Title
Insulin leakage
Description
The rate of insulin leakage after injection is observational
Time Frame
Up to 7 days
Title
Pain when insulin injection
Description
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.
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Sadegh Bagheri Baghdasht
Phone
0098 936 8214509
Email
hiasdasd0@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esmail Heidaranlu
Organizational Affiliation
Baqiyatallah university of medical sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Mohammad Sadegh Bagheri Baghdasht
City
Tehran
ZIP/Postal Code
0
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Sadegh Bagheri Baghdasht

12. IPD Sharing Statement

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

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