Status:
COMPLETED
Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)
Lead Sponsor:
Kinderkrankenhaus auf der Bult
Conditions:
Patient Care
Drug Therapy
Eligibility:
All Genders
2-14 years
Phase:
NA
Brief Summary
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of alerts according ...
Detailed Description
Monocentric, randomized, controlled cross-over safety evaluation study. For the study, 20 subjects per age group (small children 2-\<9 years, children/adolescents ≥9-14 years) will be enrolled (total ...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- At time of screening: Subjects who are 2-14 years are determined by the investigator to be psychologically sound (e.g. no depression, anxiety disorder, traumatic stress disorder) in order to successfully participate in this study
- Subject has been diagnosed with type 1 diabetes ≥ 1 year Study-specific inclusion criteria
- Subjects will be considered for enrollment in the study if they meet all of the following criteria:
- Subjects who are 2-14 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
- Subject is willing to wear the system continuously throughout the study
- Subject is willing to perform required sensor calibrations
- Total daily dose of Insulin \>8 U
- Subject has an A1C value \< 12.0% (as processed by Laboratory) at time of screening visit
- Subject must be on Pump therapy for \>3 months prior to Screening
- Subject may also be on sensor augmented pump therapy.
- If subject has celiac disease it has been adequately treated as proven by Transglutamase-Antibodies in normal range
Exclusion
- Event of severe hypoglycemia in past 3 months (as per ISPAD Guideline Definition 2014: seizure or loss of consciousness.)
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
- Subject has had any of the following new diagnoses within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Subject has a clinical significant abnormality (out of reference range, as processed by Laboratory) in thyroid-stimulating hormone (TSH) at time of screening visit
- Subjects suffering from Morbus Addison, heart failure \>NYHA II, chronic pulmonal disease \>GOLD II, chronic arterial insuffiency, known cancer disease, diabetic kidney disease, diabetic autonom or peropheral neuropathy
- Subject tests positive in the drug screen
- Subject has taken any oral, injectable, or IV steroids within 8 weeks prior time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study; furthermore patients using antipsychotic drugs, antidepressive, ß-blocking agents are not permitted to participate
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 4 weeks
- Subject is currently abusing illicit drugs
- Subject is currently abusing prescription drugs
- Subject is currently abusing alcohol
- Subject is using pramlintide (Symlin) at time of screening
- Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
- Subject has elective surgery planned that requires general anesthesia during the course of the study
- Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject diagnosed with current eating disorder such as anorexia or bulimia
- Subject has been diagnosed with chronic kidney disease that results in chronic anemia
- Subject is on dialysis
- Subjects known for factitial hypoglycemia or possible suicidal tendencies.
- Patients who are unwilling or unable to perform a minimum of four blood glucose tests per day.
- People who are unwilling or unable to maintain contact with their healthcare professional.
- Patients whose vision or hearing does not allow cognition of pump signals and alarms.
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03815487
Start Date
November 19 2018
End Date
October 10 2020
Last Update
June 16 2021
Active Locations (1)
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1
Kinder - und Jugendkrankenhaus AUF DER BULT
Hanover, Germany, 30173