Post Authorisation Safety Study (PASS): an European observational cohort of patients with type 1 diabetes treated via intraperitoneal route with Insuman Implantable 400 IU/mL in Medtronic MiniMed implantable pump (IIMOS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multinational, multicenter, observational, prospective study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10AB01) insulin (human)

  insulin (human)
• Medical condition to be studied:
  Type 1 diabetes mellitus

Population studied

• Short description of the study population:
  Adult patients with type 1 diabetes who cannot control their diabetes with subcutaneous insulin therapy present with frequent, severe hyper- and/or hypoglycaemia treated with Insuman Implantable 400 IU/mL. ; Inclusion Criteria: ; • Patients with type 1 diabetes using Insuman Implantable in a Medtronic MiniMed implantable pump; • Signed written informed consent
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Type 1 diabetes patients
• Estimated number of subjects:
  260

Study design details

• Main study objective:
  The primary objective of the study is to better characterize some of the following important identified risks: • Severe hypoglycaemia • Hyperglycaemia caused by insulin underdelivery due to pump dysfunction or catheter blockage • Pump pocket infection • Abnormal healing (at the surgical incision site after device implantation) • Skin erosion
• Outcomes:
  • Severe hypoglycaemia • Hyperglycaemia caused by insulin underdelivery due to pump dysfunction or catheter blockage • Pump pocket infection • Abnormal healing (at the surgical incision site after device implantation) • Skin erosion, • hypersensitivity reactions to Insuman Implantable 400 IU/mL, hypersensitivity reactions to pump material and focal hepatic steatosis, • Safety in pregnant and lactating women and long term safety (including effect of lon
• Data analysis plan:
  Since the primary objective is to monitor the important identified risks, the analysis will be descriptive and the multiplicity control will not be considered. For the important identified risks including severe hypoglycaemia, hyperglycaemia due to underdelivery of insulin, pump pocket infections, skin erosion, and abnormal healing, the time to first event will be depicted by the Kaplan-Meier plot. The cumulative event rate and its 95% confidence interval (CI) will be presented yearly. The cumulative risk over the entire study and the instantaneous risk expressed as the hazard function over time will be presented graphically according to the time expressed in years and using a kernel smoothing method. A horizontal line will represent the incidence rate calculated, as number of patients with one or more events divided by the number of patients treated.