Posted by on Aug 31, 2019 in Diabetes mellitus | 0 comments

In a nutshell

This study is comparing the effectiveness of two types of insulin when they are given using an automated insulin pump to patients with type 1 diabetes (T1D). The main outcome will be to examine patients’ blood glucose levels after 6 weeks. This study is recruiting in Austin, TX, US.

The details

T1D is a disease where a patient’s blood glucose levels are too high. Blood sugar levels can be reduced using a drug called insulin, which needs to be injected to work properly. Many patients struggle with injections, particularly injection timing. 

Medtronic 670G pump is an automated pump which monitors patients’ blood sugar levels constantly and adjusts the amount of insulin accordingly. Fiasp is one brand of insulin and Novolog is another. It is not known how effective these drugs are when given to patients using an automated pump. This study aims to compare Fiasp and Novolog when given to patients with T1D in the Medtronic 670G pump. The main outcome will be to examine patients’ blood glucose levels after 6 weeks.

Who are they looking for?

This study is recruiting 40 patients with T1D. Patients must be over 18 and have a diagnosis of T1D for over a year. Patients must try the Medtronic 670G pump for 30 days before the start of the study.  Patients must be using the same type of insulin for 30 days before the start of the study. HbA1c (blood sugar levels over the past 3 months) must be less than 8.5%.

Patients who have known reactions to Fiasp, Novolog or Medtronic 670G pump cannot participate. Female patients who are pregnant or breastfeeding cannot participate. Patients who participated in another clinical trial 28 days before the study starts cannot participate. Patients with a history of heart, liver or kidney problems cannot participate. Patients who were hospitalized for diabetic ketoacidosis (a complication of diabetes caused by very high blood sugar levels) 180 days before the start of the study cannot participate. Patients diagnosed with certain types of cancer cannot participate. 

How will it work

Patients will be divided into two groups. The first group will receive Fiasp for 7 weeks followed by Novolog for 7 weeks. The second group will receive Novolog for 7 weeks followed by Fiasp for 7 weeks. All patients will receive insulin drugs using the Medtronic 670G pump.

After 6 weeks of treatment, blood sugar levels will be measured 1 hour after a meal. Patients will be monitored for insulin use, blood sugar levels and side effects for 14 weeks. Blood sugars will be measured after 20 weeks.

Clinical trial locations

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Type:Interventional
Participants:40
Study ID:NCT03977727
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