DiabetesNCT06074965
Impact of Two Medtronic Infusion Sets on Lipohypertrophy in Type 1 Diabetes (T1DM) Patients Thought to Have LH
A study testing Medtronic Extended Infusion Set in people with Diabetes and Diabetes Mellitus, Type 1, run by Azienda Ospedaliera San Camillo Forlanini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Lipohypertrophy
- What is being tested?
- Medtronic Extended Infusion Set
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2022to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Lipohypertrophy
- Being tested
- Medtronic Extended Infusion Set
- Keywords
- Lipohypertrophy, Infusion Sets, Insulin Pump, CGM
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Extended Infusion SetDevice
Also called Medtronic Quick-set™ 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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Medtronic Extended Infusion Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (6)
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
Measured: 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/
Measured: 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
Measured: 6 months
Glycemic variability: Standard Deviation (SD), Coefficient of Variation (CV), mean amplitude of glycemic excursions (MAGE)
Measured: 6 months
Cohort analysis by age
Measured: 6 months
Cohort analysis by duration of diabetes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start5 Oct 2022
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Camillo Forlanini
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Claudio Tubili, Azienda Ospedaliera San Camillo Forlanini
- Investigators
- Claudio Tubili, Principal investigator, Azienda Ospedaliera San Camillo Forlanini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074965
- Sponsor's protocol ID
- 299_CELazio1_220322
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06074965
- Acronym / sponsor ID
- 299_CELazio1_220322
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Lipohypertrophy
- Keywords
- Lipohypertrophy, Infusion Sets, Insulin Pump, CGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Camillo ForlaniniUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Medtronic Extended Infusion SetThese subjects will be using infusion set A for the first 3 months and infusion set B for the following 3 months |
| Arm 2 | Experimental | Device: Medtronic Extended Infusion SetThese subjects will be using infusion set B for the first 3 months and infusion set A for the following 3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Extended Infusion SetAlso: Medtronic Quick-set™ Infusion SetEach 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). | Device | Arm 1, Arm 2 |
Primary outcome
Event rate of lipohypertrophy (LH)
Time frame: 6 months
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 secondary outcomes
Continuous Glucose Monitoring (CGM) data: Time Above Range (TAR)
Time frame: 6 months
Continuous Glucose Monitoring (CGM) data: Time Below Range (TBR)
Time frame: 6 months
Continuous Glucose Monitoring (CGM) data: Time In Range (TIR)
Time frame: 6 months
Glycemic variability: Standard Deviation (SD), Coefficient of Variation (CV), mean amplitude of glycemic excursions (MAGE)
Time frame: 6 months
Cohort analysis by age
Time frame: 6 months
Cohort analysis by duration of diabetes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Tubili principal investigator
Azienda Ospedaliera San Camillo Forlanini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Extended Infusion Set in people with Diabetes and Diabetes Mellitus, Type 1, run by Azienda Ospedaliera San Camillo Forlanini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event rate of lipohypertrophy (LH) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.