Primary objectives: * Continuous glucose values with registration of carbohydrate intake, vital signs, physical activity, emotional stress and insulin delivery. The data will be used to develop forecasting algorithms for glucose levels on a time…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
·Glucose · Physical activity · ECG · Temperature · Breathing rate · Emotional
stress . Food intake · Insulin dosage · Other medication
· Age · Gender · Height · Weight · Time since diagnose · HbA1C · Type of
medication · Type of insulin
Secondary outcome
.
Background summary
The purpose of this study is to develop a method for prediction of future
glucose values using additional vital body signs. It is known that glucose
levels in the human blood are affected by multiple physiological processes. The
most important are food intake, physical activity and emotional stress.
Additionally glucose values are being changed by medication, especially
insulin. Thus, it is reasonable that any method to predict glucose levels will
benefit from additional measurements that relate to these parameters.
In this study it will be investigated how different vital body signs correlate
to glucose levels and how these additional parameters can be used to improve
the prediction of glucose levels.
Study objective
Primary objectives:
* Continuous glucose values with registration of carbohydrate intake, vital
signs, physical activity, emotional stress and insulin delivery.
The data will be used to develop forecasting algorithms for glucose levels on a
time scale of 30-60 minutes.
Secondary objectives:
* Distinguishing between healthy people and people with diabetes
* Determine the severity/control of the disease based on the recorded time
series.
Study design
This is a one week observational, open, non interventional, controlled study of
10 type 1 insulin pump treated diabetes patients and 10 healthy persons. The
trial is monocenter and will include an initiation visit and final visit.
From each diabetic patient and each volunteer included in the study (see
population), time series traces of physiological parameter will be collected
over a period the sensor is working accurate (mean working is 72 hours).
Available parameters from the patient record relevant to blood glucose will be
included to enable personalization of the algorithm and validation of the
results.
Study burden and risks
.
Postbus 90052
5600 PD Eindhoven
Nederland
Postbus 90052
5600 PD Eindhoven
Nederland
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19806.015.07 |