Status:
COMPLETED
Impact of Two Medtronic Infusion Sets on Lipohypertrophy in Type 1 Diabetes (T1DM) Patients Thought to Have LH
Lead Sponsor:
Azienda Ospedaliera San Camillo Forlanini
Collaborating Sponsors:
Medtronic
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is an observational study using ultrasound (US) and palpation to assess the impact of infusion sets on lipohypertrophy (LH) in an infusion set crossover study.
Detailed Description
This is a 1-center, prospective, open label, 2-arm study of ≥16 subjects who use the insulin pumps. These subjects will be using 2 types of infusion sets for two periods of 3 months each type that wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06074965
Start Date
October 5 2022
End Date
May 23 2023
Last Update
October 10 2023
Active Locations (1)
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1
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152