|- candidate number||9084|
|- NTR Number||NTR2742|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-feb-2011|
|- Secondary IDs||NL33990.041.10 METC UMC Utrecht|
|- Public Title||“Improving preconceptional suboptimal glycaemic control in type 1 diabetes using RealTime Continuous Glucose Monitoring (RT-CGMS): A Randomised Clinical Trial.”
|- Scientific Title||“Improving preconceptional suboptimal glycaemic control in type 1 diabetes using RealTime Continuous Glucose Monitoring (RT-CGMS): A Randomised Clinical Trial.”
|- hypothesis||This study is designed to investigate whether it is possible to achieve substantial improvement of HbA1c values in preconceptional suboptimal regulated type 1 diabetes mellitus (which is HbA1c between 7.0-7.5%) by using RT-CGMS.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 1 (DM type I), Preconceptional, Glucose monitoring, Real-time|
|- 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||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).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2011|
|- planned closingdate||1-sep-2012|
|- Target number of participants||20|
|- 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 times a blind Continuous Glucose Monitoring System measurement of 48 hours (control group). |
|- Primary outcome||Absolute reduction in HbA1c (HbA1c at the end of study versus HbA1c at inclusion).
|- Secondary outcome||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;
11. Satisfaction with the device.
|- Timepoints||0, 12 and 16 weeks.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. L.B.E.A. Hoeks|
|- CONTACT for SCIENTIFIC QUERIES||Drs. L.B.E.A. Hoeks|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|H.W. de Valk|
|- Publications||"Real-Time Continuous Glucose Monitoring System for Treatment of Diabetes, a Systematic Review". L.B.E.A. Hoeks, W.L. Greven et al. Diabetic Medicine. In Press.|
|- Brief summary||Despite major advances in diabetes care the incidence of adverse pregnancy outcomes in women with type 1 diabetes mellitus is still significantly higher than in non-diabetic pregnancies. It is known that suboptimal glucose regulation is associated with adverse pregnancy outcomes: Suboptimal control in the periconceptional period is associated with the development of congenital malformations.|
There is general consensus that prepregnancy care and optimal glycaemic control is mandatory to achieve the best possible pregnancy outcome in these women with HbA1c as the parameter reflecting the quality of glycaemic control. The latest guidelines state that we should aim for a preconceptional HbA1c-level as near the normal range as possible to achieve the best outcomes but at least an HbA1c < 7.0% (53 mmol/mol).
With lowering of the HbA1c-level towards the normal range, the risk of hypoglycaemia and severe hypoglycaemia increases, currently posing a barrier to reach best control.
The current mainstay of monitoring glycaemic control (self-measurement of blood glucose levels by finger stick) only provides snapshot images, limiting the possibilities to improve glycaemic control.
Real-Time Continuous Glucose Monitoring System (RT-CGMS) allows instantaneous display of actual glucose values combined with an alert-function when glucose levels or changes in levels fall outside preset individualised limits. Studies have shown that RT-CGMS can improve glycaemic control in patients with type 1 diabetes but the studied populations were heterogenic and no studies have been done with RT-CGMS during the preconceptional or pregnant period. No studies have been done in our population.
Glycaemic variability is a new concept in diabetes care and it has been suggested that the degree of glucose variability may be linked to adverse outcomes. Rt_CGMS may also decrease glucose variability.
|- Main changes (audit trail)|
|- RECORD||8-feb-2011 - 25-feb-2012|