HbA1c can improve in type 1 diabetes patients who continuously use the Paradigm® REAL-Time system.
ID
Bron
Verkorte titel
Aandoening
Type I Diabetes
Ondersteuning
Academic Medical Centre
Department of Internal Medicine
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
HbA1c.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
HbA1c can improve in type 1 diabetes patients who continuously use the Paradigm® REAL-Time system.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Using the Paradigm® REAL-Time device, consisting of a continuous subcutaneous glucose sensor, equipped with an alarm function for upcoming hypo- and hyperglycemia, an insulin pump and a Bolus Wizard® calculator
Publiek
Department of Internal Medicine
J. Hermanides
Academic Medical Centre
Department of Internal Medicine
P.O.Box 22660
J. Hermanides
F4-257
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+3120-5668136
j.hermanides@amc.uva.nl
Wetenschappelijk
Department of Internal Medicine
J. Hermanides
Academic Medical Centre
Department of Internal Medicine
P.O.Box 22660
J. Hermanides
F4-257
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+3120-5668136
j.hermanides@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients have been diagnosed with type 1 diabetes at least 12 months prior to study entry;
2. Patients are between 18 and 65 years of age, inclusive;
3. Patients are on multiple injection treatment, defined as a basal insulin analogue qd or bid and a rapid-acting insulin analogue used with every meal OR
Patients are on conventional MIT in whom previous treatment with long- and rapid-acting insulin has failed;
4. Patients are on multiple injection treatment at least 3 months prior to inclusion;
5. Patients have a baseline HbA1c ¡Ý 8.2%
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patient has hearing problems or impaired vision that might hinder recognition of the sensor alarm or screen alarms, respectively;
2. Alcohol or drug abuse other than nicotine;
3. Abdominal abnormalities, like lipodystrophia that might hinder either glucose measurement by the sensor or the continuous subcutaneous insulin infusion;
4. Current pharmaceutical treatment for any psychiatric disorder other than depression;
5. Treatment with CSII in the last six months prior to entry in the study;
6. Patients suffering from Cancer, Heart Failure, kidney disease (creatinin > 150 micromol/l) and other chronic debilitating conditions;
7. Patient is unwilling or unable to comply with the provisions of the protocol;
8. Patient has scheduled a vacation which will occur between Visit 1 and Visit 2;
9. Patient has planned trips when he/she will be out of telephone reach from the study medical care for >5 days or to a place where he/she cannot comply with study procedures;
10. Being pregnant, or the wish to become pregnant during the trial;
11. Patient is participating in another device or drug study.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL849 |
NTR-old | NTR863 |
Ander register | : N/A |
ISRCTN | ISRCTN22472013 |