NCT04460092

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

Status unknown NA Last updated 7 July 2020

What this trial tests

NA trial testing 5-mm 32-gauge Insulin needles in the first three days of Intervention in Diabetes Mellitus, Type 2 in 100 participants. Status unknown.

Timeline

25 May 2020

Primary endpoint
29 June 2020

25 September 2020

Quick facts

Lead sponsor	Baqiyatallah Medical Sciences University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	100
Start date	25 May 2020
Primary completion	29 June 2020
Estimated completion	25 September 2020
Sites	1 location across Iran

Drugs / interventions tested

• 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

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Baqiyatallah Medical Sciences University

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.