Use of a real time continuous glucose monitoring system (RT-CGMS) in type 1 diabetes patients on continuous intraperitoneal insulin infusion (CIPII). A feasibility study.

Use of a real time continuous glucose monitoring system (RT-CGMS) in type 1 diabetes patients on continuous intraperitoneal insulin infusion (CIPII). A feasibility study. - RT-CGMS in CIPII / IP-SENSOR study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31251

Enrollment

Registered

2007-07-30

Start date

2007-12-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

diabetes

Interventions

There are 3 study phases. In the Baseline phase (3 days), all patients will have the RT-CGMS blinded so that no information on blood glucose values measured and stored by the RT-CGMS will be availab

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients on CIPII and treated in the Isala Clinic, Zwolle, The Netherlands. Age >18 years Uncontrolled diabetes mellitus type 1; HbA1c at last measurement (not longer than 6 weeks ago) >7.5% and/or >5 hypoglycaemic events /week as measured by SMBG.

Exclusion criteria

Exclusion criteria: Failure to obtain informed consent

Design outcomes

Primary

Measure	Time frame
percentage of time spent in euglycaemia	—

Secondary

Measure	Time frame
percentage of time spent in hypoglycaemia and hyperglycaemia. incidence of hypoglycaemia incidence of adverse effects Number of SMBG performed Number of adjustments of insulin therapy. Patient satisfaction	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)