Diabetes Diabetes Mellitus
Conditions
Interventions
RT-CGMS during 7 consecutive days every other week (in total: 8 of 16 weeks)
Results will be used for counseling / treatment adjustments
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - diagnosed with diabetes mellitus 1 at least for one year diagnosis - insulin pump for at least 3 months - reliable performance of SMBG at least 5 times a day for at least 5 days a week - child wish - stable HbA1c 43-53 mmol/mol: the last 2 values +/- 3 mmol/mol - willing to (patient herself) and capable of (as estimated by treating doctor) using RT-CGMS - able to read and speak Dutch - written informed consent - internet access (uploading results sensor)
Exclusion criteria
Exclusion criteria: - co-existent medical problems that would interfere with study participation - use of medication that could influence glycaemic control (for example corticosteroids) in last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome - Absolute reduction in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes - Incidence of severe hypoglycaemia - Percentage of women with a fall in HbA1c of >= 5 mmol/mol - number of consultations (by telephone, internet, on the out-patient clinic) - Change in glycaemic variability - Composite end point: reduction of HbA1 >= 5 mmol/mol without an episode of severe hypoglycemia - Frequency of use RT-CGMS - Fear of hypoglycaemia - Quality-of-life - Satisfaction with the device. | — |
Countries
Netherlands
Outcome results
None listed