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Patient satisfaction with a new smart and cost-effective Insulin Patch Pump System in type 1 diabetes patients using CSII and CGM or Flash glucose monitoring system

Patient satisfaction with a new smart and cost-effective Insulin Patch Pump System in type 1 diabetes patients using CSII and CGM or Flash glucose monitoring system - Patient satisfaction with Equil patchpump

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55242
Enrollment
20
Registered
2020-11-09
Start date
2021-01-27
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 1 diabetes

Interventions

None listed

Sponsors

Van Heek Medical
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Male and female patients * T1D patients 18 years * Using CSII for 12 months or longer and needing a new pump within 6 months * Using CGM or FGM * Written informed consent obtained from the patient

Exclusion criteria

Exclusion criteria: * Pregnancy or pregnancy wish * Patients unable to understand spoken and written Dutch language * Patients on (hybrid) closed loop systems, i.e. Medtronic 670G pump * Patients on Medtronic 640G CSII pump that also use CGM-based *stop before low* * Patients with unstable glucose regulation, for example frequent hypo- or hyperglycaemia * Not able to perform the study according to the treating physician * Severe comorbidity and/or psychiatric disease

Design outcomes

Primary

MeasureTime frame
Patient satisfaction compared to current CSII system

Secondary

MeasureTime frame
Number of perceived dysfunctions, unexpected hypo- and hyperglycaemia, ketoacidosis

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)