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

The Impact of Two Medtronic Infusion Sets (a 3-day Set & a 7-day Set) on Lipohyperthrophy (LH) in Persons With Type 1 Diabetes (T1D) and Thought to Have LH

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetes Mellitus, Type 1; Lipohypertrophy
• Intervention / Treatment: Device: Medtronic Extended Infusion Set

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 will serve as an exploratory pilot study to assess the impact of infusion sets on Lipohypertrophy LH (see Figure 1 for study design).

Each subject will use their own MiniMed™ 670G insulin system as usual. Each subject will be given 2 types of infusion sets to wear and change sets per label use (3 days for Quick-set™ and 7 days for Medtronic Extended). Each type of infusion set with the longest length (43" in) will be used for this study. 7-day reservoirs will be used with the Medtronic Extended and 3-day reservoirs will be used with the Quick-set™. The infusion set(s) or reservoir(s) can be replaced independent of each other for Medtronic Extended.

The subject will use either Medtronic Extended or Quick-set™ infusion set for consecutive 3 months. During the three-month period, either the right side or the left side of the abdomen will be designated for one or the other infusion set (defined randomly). For each type of infusion set, a coordinate rule for site rotation will be given to have the Set placed in a specified area (left or right side) of anterior abdominal wall.

For each placement/wear, a daily log will be given to the subject to record time and location for the infusion set placement. Patients will be instructed to recognize areas of clinical apparent LH sites and refrain from inserting in these areas. At home, the subject will be expected to inspect their infusion site on a daily basis and if they observe signs of infection (i.e. erythema > 1 cm in diameter with warmth, pain, and/ or induration) at the infusion site, they should call the investigational center. In addition to the study procedures, the subjects are to continue their standard routine care. In the end of each month, the subject should self-inspected by palpation for LH and record the findings on the daily log.

At each study visit, insulin pump and CONTOUR® NEXT LINK 2.4 study meter will be uploaded into CareLink™ Personal For Clinical Research. Also, all the infusion sites will be examined ultrasonically for LH.

At each visit the clinical team will assess the skin in a systematic using the palpation method procedure and the ultrasound (US) evaluation procedure.

All participants will be asked to give demographic details and medical history. They will be asked to complete a series of questionnaires about their pump routine, diabetes distress, insulin treatment satisfaction and quality of life. All participants will have a baseline glycated hemoglobin (HbA1C) taken. The Total Daily Dose (TDD) will be calculated based on the CareLink™ data.

It is anticipated that approximately 16 subjects will complete the study and up to 20 subjects may be screened. As this is an exploratory study, no power assumptions are planned. The study is anticipated to last up to 12 months.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 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; 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).; Other Names: Medtronic Quick-set™ Infusion Set
Experimental: Arm 2; 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; 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).; Other Names: Medtronic Quick-set™ Infusion Set

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Glucose Monitoring (CGM) data: Time Above Range (TAR)	Duration, and area under the curve (AUC) when Sensor Glucose>180, >240, and >250 mg/dL	6 months
Continuous Glucose Monitoring (CGM) data: Time Below Range (TBR)	Duration, area under the curve (AUC) when Sensor Glucose <50, <60, and <70 mg/	6 months
Continuous Glucose Monitoring (CGM) data: Time In Range (TIR)	Duration, area under the curve (AUC) when Sensor Glucose > 70 e < 180 mg/dL	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
Cohort analysis by duration of diabetes		6 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera San Camillo Forlanini
• Collaborators: Medtronic
• Investigators: Principal Investigator: Claudio Tubili, Azienda Ospedaliera San Camillo Forlanini

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Estimated): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: CGM; Insulin Pump; Lipohypertrophy; Infusion Sets
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 299_CELazio1_220322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No