|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03212950 |
|
Date of registration:
|
03/07/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes
|
|
Scientific title:
|
Day and Night Closed-Loop Glycemic Control With Faster-Acting Insulin Aspart in Young Adults With Type 1 Diabetes Using DreaMed Glucositter - The Fast PHYSI-DREAM Study |
|
Date of first enrolment:
|
July 10, 2017 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03212950 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Slovenia
| | | | | | | |
|
Contacts
|
|
Name:
|
Tadej Battelino, Prof, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Ljubljana, Faculty of Medicine |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. The subject has documented T1D, as defined by the American Diabetes Association and
World Health Organization (ADA/WHO) for at least 1 year prior to study enrolment
2. Documented evidence should exist within the patient history of T1D
3. The subject is between 18 and 25 years of age (inclusive) at the time of enrolment
4. The subject has been treated with an insulin pump for at least 3 months
5. The subject has an A1C value = 9% based on analysis from the local laboratory at the
time of enrolment
? A1C testing must follow National Glycohemoglobin Standardization Program (NGSP)
standards.
6. The subject is willing to follow all study instructions
7. Subject is available for the entire study duration and follow-up visits
8. Subject is willing to perform daily self-monitoring of blood glucose (SMBG) and
required sensor calibrations
9. If subject has celiac/Hashimoto disease, the disease has to be adequately treated as
determined by the investigator
10. Subject has a BMI above 5th centile and below 95th centile for age, respectively.
Exclusion Criteria:
1. Concomitant diseases that influence metabolic control (e.g. anemia, significantly
impaired hepatic function, renal failure, history of adrenal insufficiency) or other
medical conditions, which in the investigator's opinion, may compromise patient
safety; Note: Adequately treated thyroid disease and celiac disease do not exclude
subjects from enrollment.
2. Significant co-morbidity that, in the opinion of the investigators would preclude
participation in the study (e.g. current treatment for cancer, mental disorder)
3. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior
to screening, or plans to take oral or parenteral glucocorticoids during the study.
Exceptions: Short term oral glucocorticoids up to 7 days, inhaled steroids.
4. Subject is taking antidiabetic agents or other medications, which could be a
contraindication to participation in the study by the judgment of the investigator.
5. Subject is participating in another study of a medical device or drug that could
affect glucose measurements or glucose management or Receipt of any investigational
medical product within 1 month prior to screening (Visit 1).
6. Female subject of child-bearing potential who is pregnant, breast-feeding, or planning
to become pregnant during the study.
7. Subject has a history of one or more episodes of Diabetic Ketoacidosis (DKA) requiring
hospitalization within a month prior to the screening.
8. Subject has current or recent history of alcohol or drug abuse.
9. Subject has visual impairment or hearing loss, which in the investigator's opinion,
may compromise patient ability to perform study procedures safely (child and parent
should be evaluated as a unit).
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Type 1 Diabetes Mellitus
|
|
Intervention(s)
|
|
Drug: Fast-CL
|
|
Drug: Regular-CL
|
|
Primary Outcome(s)
|
|
Time within range 3.9 - 10 mmol/l (70 - 180 mg/dl)
[Time Frame: 28 hours]
|
|
Secondary ID(s)
|
|
PD-FAST-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|