Collection of and monitoring continuous glucose data to test algorithms for a glucose monitor (DATA Trial)

Completed

• Conditions: Diabetes mellitus type 1; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN18000305
• Lead Sponsor: Academic Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Aged 18 years or above
2. Diagnosed with Type 1 diabetes mellitus at least 6 months according to the WHO definition
3. Body Mass Index (BMI) <35 kg/m²
4. Willing to wear a Continuous Glucose Monitoring (CGM) device for the duration of the seven study days and undergo all study procedures
5. HbA1c <10%
6. If patient is on antihypertensive, thyroid, anti-depressant or lipid lowering medication, patient must have stability on the medication for at least 1 month prior to enrolment in the study and for the study duration
7. Signed informed consent form prior to study entry

Exclusion Criteria

1. Patient is pregnant, or breast feeding during the period of the study
2. Patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
3. Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient?s safety or successful participation in the study
4. Patient is actively enrolled in another clinical trial or took part in a study within 30 days
5. Known adrenal gland problem, pancreatic tumour, or insulinoma
6. Retinopathy except background retinopathy according to eye fundus examination during the last year
7. Known bleeding diathesis or dyscrasia
8. Inability of the patient to comply with all study procedures
9. Inability of the patient to understand the patient information
10. Patient donated blood in the last 3 months

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Continuous Glucose Monitoring (CGM) data<br>2. Self-monitoring blood glucose (SMBG) data<br>3. Insulin doses<br>4. Composition of meals and calibration data

Secondary Outcome Measures

Name	Time	Method
The collected data will be used for the identification of the parameters, i.e. the gradient g and <br>time constant t, which characterize the BG-to-IG dynamic model