Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose
NCT04460092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-07-07
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
Interventions
- 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 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
- 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
Sponsors & Collaborators
-
Baqiyatallah Medical Sciences University
lead OTHER
Principal Investigators
-
Esmail Heidaranlu · Baqiyatallah Medical Sciences University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-25
- Primary Completion
- 2020-06-29
- Completion
- 2020-09-25
Countries
- Iran
Study Locations
More Related Trials
-
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
NCT02690467 ·Status: UNKNOWN ·Phase: NA
-
Comparison of Glycemic Control Achieved With 2 Different Needles
NCT00572052 ·Status: COMPLETED ·Phase: PHASE4
-
Reusing Needles for Subcutaneous Insulin Injection in Patients With Type 2 Diabetes
NCT05407233 ·Status: COMPLETED ·Phase: NA
-
Comparison of NovoFine® Needles (4 mm vs. 6 mm)
NCT00343343 ·Status: COMPLETED ·Phase: PHASE2
-
Which Needle Length for Injecting Insulin
NCT00292890 ·Status: COMPLETED ·Phase: NA
-
Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles
NCT00871416 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
NCT00872560 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM
NCT04682795 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
NCT04093284 ·Status: UNKNOWN ·Phase: NA
-
Study on the Effects on Blood Glucose Following Intradermal and Subcutaneous Dosing of Insulin in Diabetic Patients
NCT01120444 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Pharmacokinetic Comparison of Intradermal Versus Sub-cutaneous Insulin and Glucagon Delivery in Type 1 Diabetes
NCT01684956 ·Status: UNKNOWN ·Phase: PHASE2
-
Comparing the Effects of Insulin Glargine on Blood Glucose Between Needle-free Jet Injection and Insulin Pen
NCT04074603 ·Status: COMPLETED ·Phase: NA
-
A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle
NCT00602914 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Comparison of Vehicle Delivery Depth Using the NovoFine® 5 mm Needle With or Without a Skin Fold and Inserted at Either 45 or 90 Degrees
NCT00894270 ·Status: COMPLETED ·Phase: PHASE4
-
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
NCT04090242 ·Status: TERMINATED ·Phase: NA
-
Syringes Replacement for Insulin Application for Pens Device in a Population of Elderly Patients With Type 2 Diabetes: Multifactorial Intervention to Improve Glycemic Control
NCT02517242 ·Status: UNKNOWN ·Phase: PHASE4
-
Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe
NCT01996189 ·Status: COMPLETED ·Phase: PHASE2
-
A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use
NCT03420040 ·Status: UNKNOWN ·Phase: NA
-
Comparative User Experiences With BD Nano™ PRO 4mm x 32G Extra Thin Wall Pen Needle vs Three Commercially Available Pen Needles
NCT03878758 ·Status: COMPLETED ·Phase: NA
-
The Role of Proper Insulin Injection Technique in the Treatment of Diabetes Mellitus
NCT04120974 ·Status: COMPLETED ·Phase: NA
-
Pharmacokinetics/Dynamics of Basal (Continuous) Insulin Infusion Administered Either Intradermally or Subcutaneously
NCT01061216 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
NCT04253431 ·Status: COMPLETED ·Phase: NA
-
Patient Experiences With Injection Needles
NCT02531776 ·Status: COMPLETED ·Phase: NA
-
Effect of Needle-free Jet Injection of Insulin on Glucose Control and Injection Feelings in Type 1 Diabetic Patients
NCT04094740 ·Status: UNKNOWN ·Phase: NA
-
Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
NCT02443714 ·Status: COMPLETED ·Phase: PHASE4