Type 1 diabetes, insulin dependent diabetes
Conditions
Interventions
The investigational product is the updated software algorithm to be used in the AP system of Inreda Diabetic. This updated software algorithm will be implemented in the current CE-marked AP system, th
In the updated software algorithm, new features will be introduced that will be personalized to the individual to achieve improved glycemic control. These features are an adjustable target and recurri
The target value is a pre-defined ‘optimal’ blood glucose value that the AP strives at achieving. In the current software algorithm, this target value is fixed for all individuals. However, this fixed
based on the participant’s medical history, glucometrics (primarily TIR, TBR, and mean glucose), personal preferences, and other baseline characteristics. This target value can be higher, lower, or si
The second type of features evaluated in this study are time frames. In these time frames the insulin setting can be set either higher or lower compared to the basal insulin settings. The purpose of t
Sponsors
Inreda Diabetic
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosed with diabetes mellitus type 1Treated with the Inreda AP system for a minimum of 1 monthAge between 18 and 75 yearsWilling and able to sign informed consent
Exclusion criteria
Exclusion criteria: Pregnancy and/or breastfeedingUse of oral antidiabetic agentsPheochromocytomaInsulinomaSevere liver/heart/renal failureAlcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the time spent in blood glucose range (3.9 – 10 mmol/L) on the updated software algorithm during the main study. It is hypothesized that this time spent in range is at least as high in the updated software algorithm compared to the regular AP algorithm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary safety parameters are: Normal hypo- and hyperglycemia event rate Extended hypo- and hyperglycemia event rate Adverse events Device issues Secondary performance parameters are:The proportion of time spent in range (3.9 – 10 mmol/L) during the feasibility testsThe proportion of time spent in the following ranges: Hypoglycemia level 2 (TBR2) (<3.0 mmol/L)Hypoglycemia level 1 (TBR1) (<3.9 & >3.0 mmol/L)Time in tight range (TITR) (3.9 – 7.8 mmol/L)Hyperglycemia level 1 (TAR1) (>10 & <13.9 mmol/L)Hyperglycemia level 2 (TAR2) (>13.9 mmol/L)TIR, TITR, TAR1, TAR2, TBR1, TBR2 during the day and nightThe day period is defined as the time between 06:00 and 24:00 and the night period is defined as the time between 24:00 and 06:00.TIR, TITR, TAR1, TAR2, TBR1, TBR2 during activityActivity periods will be established based on AP transmitter accelerometer data in combination with information provided by the participants about their exercising habits. Mean or median glucose concentrationMean or median glucose concentration during the day and nightMean or median glucose concentration during activity Change in Glucose Management Indicator (GMI)Glycemic variabilityCoefficient of variation Interquartile rangeSecondary AP parameters are:Daily insulin and glucagon usage. For the main study, in addition to the secondary safety, performance and AP parameters above, the following secondary parameters will also be evaluated: Percentage of patients achieving treatment goals: >70% TIR and/or <4% TBRExpectations, trust and treatment satisfaction using DMSRQ | — |
Countries
Netherlands
Contacts
Public ContactJ.S. Haan
Inreda Diabetic
Outcome results
None listed