A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use

What Was Tested

The trial (not phased) is built around Insulin Glargine.

A clinical study of the use of glargine insulin in 2 subjects with type two diabetes in China was carried out.

The two kinds of injection methods were evaluated as subcutaneous injection of insulin glargine.

It had two arms (groups): QS-M Needle Free Injector group (experimental) and Glargine pen group (active comparator).

To observe the use of insulin in glycemia under good blood glucose control in the QS-M Needle Free Injector group.

To observe the amount of insulin used by the Glargine pen group under good blood glucose control.

The registry classes the interventions as device.

Who Took Part

The registry lists 65 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female aged 18-70 years of age, women of childbearing age need to take adequate contraceptive measures to minimize the risk of pregnancy;. The standard of diagnosis of type 2 diabetes and the course of the disease is more than half a year;. 18 Kg/m2 = BMI = 30Kg/m2;. The letter of informed consent has been read and signed.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: there is conflict of interest with this research; blood glucose control is not good enough to participate in this study, such as repeated hypoglycemia, diabetic ketoacidosis or hyperosmolar coma; serious diabetic complications such as diabetic foot, diabetic nephropathy and so on;.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-11-27 with completion listed for 2018-02-20.

It ran at 1 site in China.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Change in fasting blood glucose between baseline to week 4 (time frame: baseline and week 4).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 65 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.