Randomized, controlled, multinational, multi-center, clinical trial to examine whether HbA1c can improve in type 1 diabetes patients who continuously use the Paradigm® REAL-Time system with alarm function as compared to patients on multiple injection therapy receiving one six-day period of continuous glucose monitoring - without alarm function (Guardian® REAL-Time Clinical).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24667

Enrollment

104

Registered

2007-01-24

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Type I Diabetes

Interventions

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®

Eligibility

Inclusion criteria

Inclusion criteria: 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%

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
HbA1c.	—

Secondary

Measure	Time frame
1. Hypoglycemie; 2. Hyperglycemie; 3. Quality of Life; 4. Contact tijd met onderzoeker.	—

Contacts

Public ContactJ. Hermanides

Academic Medical Centre Department of Internal Medicine J. Hermanides Academic Medical Centre Department of Internal Medicine P.O.Box 22660

j.hermanides@amc.uva.nl+3120-5668136

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)