“Improving preconceptional suboptimal glycaemic control in type 1 diabetes using RealTime Continuous Glucose Monitoring (RT-CGMS): A Randomised Clinical Trial.”

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26973

Enrollment

Registered

2011-02-08

Start date

2011-03-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

None listed

Interventions

A total of twenty patients will be randomly assigned between Real-Time Continuous Glucose Monitoring system every other week during 4 months (intervention group) or standard extensive care with two ti

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed with diabetes mellitus 1 at least for one year. Diagnosis: diagnosis < 30 years of age AND anti-GAD antibodies AND/OR experienced ketoacidosis; 2. Insulin pump (connectable with of changeable in a RT-CGMS device of Medtronic) for at least 3 months; 3. Reliable performance of SMBG at least 5 times a day for at least 5 days a week; 4. Child wish; 5. Stable HbA1c 7.0 - 7.7 (53-61 mmol/mol): if consecutive values (two months) show a decrease, this decrease is accepted up to (including) 0.5% (5 mmol/mol); 6. Age 18-41 years; 7. Willing to (patient herself) and capable of (as estimated by treating doctor) using RT-CGMS; 8. Able to read and speak Dutch; 9. Written informed consent; 10. Internet access (uploading results sensor).

Exclusion criteria

Exclusion criteria: 1. Co-existent medical problems that would interfere with study participation; 2. Use of medication that could influence glycaemic control (for example corticosteroids) in last three months; 3. ≥2 severe hypoglycaemia in the last 6 months (defined as an episode of hypoglycaemia resulting in seizure of coma or the use of glucagon or intravenous glucose for recovery).

Design outcomes

Primary

Measure	Time frame
Absolute reduction in HbA1c (HbA1c at the end of study versus HbA1c at inclusion).	—

Secondary

Measure	Time frame
1. Incidence of severe hypoglycaemia; 2. Percentage of women with a fall in HbA1c of ≥ 0.4% (≥ 5 mmol/mol); 3. Percentage of women that reach target HbA1c (<7.0% or < 53 mmol/mol); 4. Time to reach target HbA1c (< 7.0% or < 53 mmol/mol); 5. Numbers of consultations (at the clinic, by telephone, by email); 6. Change in glycaemic variability; 7. Composite end point: Reduction of HbA1 ≥ 0.4% (≥ 5 mmol/mol) without an episode of severe hypoglycaemia; 8. Frequency of use RT-CGMS; 9. Fear of hypoglycaemia; 10. Quality-of-life; 11. Satisfaction with the device.	—

Measure

Time frame

1. Incidence of severe hypoglycaemia; 2. Percentage of women with a fall in HbA1c of ≥ 0.4% (≥ 5 mmol/mol); 3. Percentage of women that reach target HbA1c (<7.0% or < 53 mmol/mol); 4. Time to reach target HbA1c (< 7.0% or < 53 mmol/mol); 5. Numbers of consultations (at the clinic, by telephone, by email); 6. Change in glycaemic variability; 7. Composite end point: Reduction of HbA1 ≥ 0.4% (≥ 5 mmol/mol) without an episode of severe hypoglycaemia; 8. Frequency of use RT-CGMS; 9. Fear of hypoglycaemia; 10. Quality-of-life; 11. Satisfaction with the device.

—

Contacts

Public ContactL.B.E.A. Hoeks

Postbus 85500

lhoeks2@umcutrecht.nl

Outcome results