Type 1 Diabetes Clinical Trial
Official title:
Evaluation of Automated Insulin Pump Settings Using the MD-Logic Pump Advisor-Adults Sub Study
Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to
the standard of care of patients with type 1 diabetes.
The objective of this feasibility study is to evaluate the efficacy and safety of automated
determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration
and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1
diabetes.The study will be consisted from two segments:(I)pilot study, 30-78 days trial
evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial
comparing MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the
aim is to enroll 15-30 subjects without control group. In segment 2, the randomized
controlled segment, the aim is to enroll 92 subjects, but enrolling up to 105 eligible
subjects to allow for dropouts.
The randomized controled study segment will be initiated after the pilot segment.Each
segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks,
sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will
wear continuous glucose sensors for 6 days; the intervention group will have up to 4
iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the
study period according to the MD-Logic Pump Advisor).For the control group (at segment 2
only), insulin pump settings will not be changed during the study period (patient's usual
standard of care).
the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of
Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's
Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin
pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as
input, sensor readings, insulin delivery and recording of the meals during home care. During
collection of the data, the patients are asked to continue their daily routine (no need for
special consideration).
The present study was designed to test the automatic algorithm that will evaluate and
change, when necessary, the patient's insulin pump settings based on prior sensor reading,
insulin delivery, and meals data that was collected while the patient is under his regular
treatment at home.
The objective of this feasibility study is to evaluate the efficacy and safety of automated
determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration
and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1
diabetes.
The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating
the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic
pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll
15-30 subjects without control group. In segment 2, the randomized controlled segment, the
aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for
dropouts.
The randomized controled study segment will be initiated after the pilot segment.Each
segment of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks,
sum of 30-78 days study duration for each segment. Before each clinic visit, subjects will
wear continuous glucose sensors for 6 days; the intervention group will have up to 4
iterations (e.g the pump setting will be reviewed and adjusted up to 4 times during the
study period according to the MD-Logic Pump Advisor).For the control group (at segment 2
only), insulin pump settings will not be changed during the study period (patient's usual
standard of care).
Endpoints:
- Primary endpoint Increase in time spent in the normal range, defined as sensor glucose
level within 70 to 180 mg/dl
- Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70
mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose
variability, quality of life measurements and subject treatment satisfaction.
Inclusion Criteria:
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII
(continuous subcutaneous insulin infusion) therapy for at least 3 months
- Age ≥ 18 years
- HbA1c at inclusion ≥ 6.0%
- No concomitant diseases that influence metabolic control
- No current use of CGM
- Subjects do not participate in any other interventional study
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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