The development of a method for prediction of future glucose values using additional vital body signs.

Completed

• Conditions: diabetes mellitus; 10018424

• Registration Number: NL-OMON31558
• Lead Sponsor: Máxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Subject uses insulin pump paradigm 512/712, 515/ 715 or real time
2. Type 1 diabetes mellitus * 1 year
3. Age * 18 years
4. BMI < 40.0 kg/m2

Exclusion Criteria

1. Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 26 weeks or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). (Adequate contraceptive measures are defined as sterilization, intra-uterine device, oral contraceptives or consistent use of barrier methods)
2. Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening.
3. Cardiac disease defined as NYHA class III or IV, unstable angina and/or myocardial infarction within 6 months prior to screening.
4.Uncontrolled hypertension (treated or untreated) as judged by the Investigator
5. Any disease or condition (such as renal, hepatic or cardiac) that according to the judgment of the investigator makes the subject unsuitable for participation in the trial.
6. Use of concomitant medication which may alter glucose metabolism including but not limited to: systemic (or inhaled) glucocorticoids or non-selective beta-blockers.
7. Substance abuse including abuse of anabolic steroids.
8. Mental incapacity or language barrier precluding adequate understanding and/or cooperation.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>·Glucose · Physical activity · ECG · Temperature · Breathing rate · Emotional<br /><br>stress . Food intake · Insulin dosage · Other medication<br /><br><br /><br>· Age · Gender · Height · Weight · Time since diagnose · HbA1C · Type of<br /><br>medication · Type of insulin</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>.</p><br>