Randomised, controlled, multinational, multicentre, clinical trial to examine whether HbA1c can improve in type one 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)

Completed

• Conditions: Diabetes Mellitus Type one (DM type one); Nutritional, Metabolic, Endocrine; Diabetes Mellitus

• Registration Number: ISRCTN22472013
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

1. Patients have been diagnosed with type one diabetes at least 12 months prior to study entry
2. Patients are between 18 and 65 years of age, inclusive
3. Patients are:
a. on Multiple Injection Treatment (MIT), defined as a basal insulin analogue once or twice a day and a rapid-acting insulin analogue used with every meal, or
b. on conventional MIT in whom previous treatment with long- and rapid-acting insulin has failed
4. Patients are on multiple injection treatment at least three months prior to inclusion
5. Patients have a baseline HbA1c of more than or equal to 8.2%

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 Continuous Subcutaneous Insulin Infusion (CSII) in the last six months prior to entry in the study
6. Patients suffering from cancer, heart failure, kidney disease (creatinine more than 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 one and visit two
9. Patient has planned trips when he/she will be out of telephone reach from the study medical care for more than five 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c levels.

Secondary Outcome Measures

Name	Time	Method
1. Hypoglycaemic<br>2. Hyperglycaemic<br>3. Quality of life<br>4. Time spent with the researcher during a visit (Contact tijd met onderzoeker)