Impact of Two Medtronic Infusion Sets on Lipohypertrophy in Type 1 Diabetes (T1DM) Patients Thought to Have LH
Diabetes, Diabetes Mellitus, Type 1, Lipohypertrophy
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Lipohypertrophy, Infusion Sets, Insulin Pump, CGM
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of type 1 diabetes and has been a pump user for at least 10 years Using a MiniMed™ 670G or 640G Insulin pump with Guardian sensor Age 18 to 80 years Hemoglobin A1c level less than or equal to 10% Not currently known to be pregnant, nor planning pregnancy during the study. Willingness to follow the protocol and sign the informed consent Use U100 Humalog (insulin lispro) or U100 NovoRapid/Novolog (insulin aspart) Exclusion Criteria: Conditions that affect the skin evaluation, e.g. scleroderma or amyloidosis A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. Pregnant or lactating females Subject has Glycosylated hemoglobin (HbA1c) > 10 % at time of screening.
Sites / Locations
- Azienda Ospedaliera San Camillo Forlanini
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm 1
Arm 2
These subjects will be using infusion set A for the first 3 months and infusion set B for the following 3 months
These subjects will be using infusion set B for the first 3 months and infusion set A for the following 3 months