diabetes
Conditions
Interventions
This study investigates the effectiveness of the Hybrid Artificial Pancreas
(Hybrid-AP) compared to a combination of an insulinpump and glucosesensor
(OPEN) targeting adult experienced insulin pump
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Aged between 18 and 70 years Diagnosed with type 1 diabetes mellitus Use of an insulin pump for at least 3 months HbA1c between 7.5% and 10%
Exclusion criteria
Exclusion criteria: Diabetic Ketoacidosis within the last 6 months Pregnancy or breastfeeding History of cardiovascular event during the prior year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: time in range, Hybrid-AP versus OPEN. The main purpose of this study is to assess the effectiveness of glucose control achieved during 2 months Hybrid-AP during the evening and night-time/ open-loop during day-time (Hybrid-AP) versus patient-managed open loop control (OPEN) in a home environment in patients with type 1 diabetes. | Extension 1&2: Artificial Pancrease versus OPEN | — |
Secondary
| Measure | Time frame |
|---|---|
| This study aims at: - Demonstrating the feasibility of prolonged hybrid use of an Artificial Pancreas model at home - Evaluating the effect of using an Artificial Pancreas in hybrid mode on patient quality of life | Extension 1&2: Same outcome measures apply | — |
Countries
Netherlands
Outcome results
None listed