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.