Impact of Two Medtronic Infusion Sets on Lipohypertrophy in Type 1 Diabetes (T1DM) Patients Thought to Have LH
Condition: Diabetes; Diabetes Mellitus, Type 1; Lipohypertrophy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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 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.
    

Intervention name(s): Medtronic Extended Infusion Set
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Medtronic Quick-set™ Infusion Set
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Lipohypertrophy; Infusion Sets; Insulin Pump; CGM