Impact of Two Medtronic Infusion Sets on Lipohypertrophy in Type 1 Diabetes (T1DM) Patients Thought to Have LH

NCT06074965 | Completed

• 1 other identifier: 299_CELazio1_220322
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1; Lipohypertrophy

Keywords

Lipohypertrophy; Infusion Sets; Insulin Pump; CGM

Outcome Measures

Primary Outcomes (1)

• Event rate of lipohypertrophy (LH)

  The study will be evaluated and summarized, including but not limited to the following: * Self-assessed LH by palpation using a visual analogue scale (VAS) 1 to 10, coupled with clinical examination by a physician if possible. * LH (appearance, location, mass, indices of vascularization and distribution) characterized by ultrasound. * The relationship between the observed LH and infusion set type, TDD, glycemic control, HbA1C etc. * Satisfaction of infusion sets using validated questionnaire, e.g. the diabetes treatment satisfaction questionnaire (DTSQ).

  6 months

Secondary Outcomes (6)

• Continuous Glucose Monitoring (CGM) data: Time Above Range (TAR)

  6 months

• Continuous Glucose Monitoring (CGM) data: Time Below Range (TBR)

  6 months

• Continuous Glucose Monitoring (CGM) data: Time In Range (TIR)

  6 months

• Glycemic variability: Standard Deviation (SD), Coefficient of Variation (CV), mean amplitude of glycemic excursions (MAGE)

  6 months

• Cohort analysis by age

  6 months

Study Arms (2)

Arm 1

EXPERIMENTAL

These subjects will be using infusion set A for the first 3 months and infusion set B for the following 3 months

Device: Medtronic Extended Infusion Set

Arm 2

EXPERIMENTAL

These subjects will be using infusion set B for the first 3 months and infusion set A for the following 3 months

Device: Medtronic Extended Infusion Set

Interventions

Medtronic Extended Infusion Set DEVICE

Each subject will be given 2 types of infusion sets to wear and change sets per label use (3 days for Medtronic Quick-set™ and 7 days for Medtronic Extended).

Also known as: Medtronic Quick-set™ Infusion Set

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera San Camillo Forlanini: lead
• Medtronic: collaborator

Study Sites (1)

Azienda Ospedaliera San Camillo Forlanini

Roma, 00152, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Claudio Tubili

  Azienda Ospedaliera San Camillo Forlanini

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Diabetology

Model Details: 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 will serve as an exploratory pilot study to assess the impact of infusion sets on lipohypertrophy

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 10, 2023
• Study Start: October 5, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

IT (1)