Cross-over Study to Evaluate the Safety and Efficacy of Night Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy in Poorly Controlled Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

An Open-label, Two-center, Randomized, Cross-over Study to Evaluate the Safety and Efficacy of Night Closed-loop Control Using the MD-Logic Automated Insulin Delivery System Compared to Sensor Augmented Pump Therapy in Poorly Controlled Patients With Type 1 Diabetes at Home

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02733211
• Other study ID #: RMC010016Ctil
• Status: Withdrawn
• Phase: N/A
• Start date: March 2019
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The MD-Logic Automated Insulin Delivery System is intended for patients with type 1 diabetes mellitus for subcutaneous infusion of insulin and the continuous measurement of interstitial glucose to aid in the management of their diabetes. The product automatically adjusts basal insulin delivery and delivers correction boluses in response to real-time glucose measurements by CGM to maintain blood glucose within the desired range, to improve metabolic control without increasing the risk of hypoglycemia.

The proposed study is an open-label, two-center, randomized, cross-over study to evaluate the safety and efficacy of night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy in poorly controlled patients with type 1 diabetes at home The objective of this pilot study is to evaluate the safety and efficacy of 4 weeks glucose control using the MD-Logic System in individuals with poorly controlled type 1 diabetes at patient's home

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Subject with type 1 diabetes >1year since diagnosis

• Insulin infusion pump (CSII) therapy for at least 3 months

• Patients able to use sensor after training based on researcher's estimation

• Age between 10 and 18 years (both included)

• HbA1c at inclusion between 7.5 and 11.0 % (both included)

• Patients willing to follow study instructions

• Patients live with at least one other adult person

• Body Mass Index Standard Deviation Score - below the 95th percentile for age

• Patients with caregivers who are capable of operating a computer based system

Exclusion Criteria:

• Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical condition, which in the Investigator's opinion, may compromise patient safety Participation in any other interventional study

• Known or suspected allergy to trial products such as adhesives, tapes, needles. An allergy to contrast medium, use of other active medical devices and planned imaging

• Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety

• Diabetic ketoacidosis in the past 1 month

• Severe hypoglycemia six month prior to enrollment

• Current use of the following medications: medications that are used to lower blood glucose , Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study

• Subject is participating in another drug or device study that could affect glucose measurements or glucose management

• Female subject who is pregnant or breast-feeding or is planning to become pregnant within the planned study duration

• Not sufficient vision or hearing to recognize pump/sensor alarms or to perform Blood Glucose-self measurements 4-times daily.

• Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus -Subject has unstable or rapidly progressive renal disease or is receiving dialysis-

• Subject has active proliferating retinopathy

• Active gastroparesis

• Patient suffers from an eating disorder

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• MD- Logic Closed Loop System
Closed Loop System
• sensor augmented pump therapy
Sensor augmented pump therapy

Locations

Country	Name	City	State
Germany	Diabetes -Zentrum fuer kinder und jugendliche	Hannover
Israel	Schneider Children's Medical Center	Petach-Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	GIF

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) during the night (23:00-7:00 h)		At the final visit- Day 115
Secondary	Percentage of glucose sensor readings within 70 to 180 mg/dl (3.9 to 10 mmol/l) per 24 hours		At the final visit- Day 115
Secondary	Percentage of glucose sensor readings below 70 mg/dl (3.9 mmol/l) during the night (23:00-7:00 h) and per 24 hours		At the final visit- Day 115
Secondary	Percentage of glucose sensor readings above 180 mg/dl (10 mmol/l) during the night (23:00-7:00 h) and per 24 hours		At the final visit- Day 115
Secondary	Average and standard deviation of glucose sensor readings per 24 hours		At the final visit- Day 115
Secondary	Fasting blood glucose levels		At the final visit- Day 115
Secondary	HbA1c change from baseline to the end of the intervention period		At the final visit- Day 115
Secondary	Acceptance and use intention of an Artificial Pancreas	Questionnaire assessing the acceptance and use intention of an Artificial Pancreas	At the final visit- Day 115
Secondary	Well-Being	Questionnaire assessing the well-being of participants	At the final visit- Day 115
Secondary	Diabetes-specific family conflicts	Questionnaire assessing the diabetes-specific family conflicts of participants	At the final visit- Day 115
Secondary	Area under the curve of glucose readings <50		At the final visit- Day 115
Secondary	Area under the curve of glucose readings <70		At the final visit- Day 115
Secondary	Area under the curve of glucose readings <60		At the final visit- Day 115
Secondary	Percentage of glucose readings <70 mg/dl		At the final visit- Day 115
Secondary	Percentage of glucose readings <60 mg/dl		At the final visit- Day 115
Secondary	Number of sensor based hypoglycemic events <70mg/dl		At the final visit- Day 115
Secondary	Number of sensor based hypoglycemic events <60mg/d		At the final visit- Day 115
Secondary	Number of sensor based hypoglycemic events <50mg/d		At the final visit- Day 115
Secondary	Area Under the Curve of sensor glucose readings >240 mg/dl		At the final visit- Day 115
Secondary	Area Under the Curve of sensor glucose readings >300 mg/dl		At the final visit- Day 115
Secondary	Percentage of sensor glucose readings >240 mg/dl		At the final visit- Day 115
Secondary	Percentage of sensor glucose readings >300 mg/dl		At the final visit- Day 115