Type 1 Diabetes Clinical Trial
Official title:
Evaluation of Automated Insulin Pump Settings Using the MD-Logic Pump Advisor-Adults Sub Study
Verified date | January 2016 |
Source | Rabin Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 18 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Subject with Type 1 diabetes (>1yr since diagnosis) 2. Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months 3. Age = 18 years 4. HbA1c at inclusion = 6.0% 5. No concomitant diseases that influence metabolic control 6. No current use of CGM 7. Subjects do not participate in any other interventional study Exclusion Criteria: 1. Known or suspected allergy to trial products. 2. 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 3. Subject is currently using CGM device 4. Diabetic ketoacidosis in the past 3 months. 5. Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment. 6. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study. 7. Subject is participating in another drug or device study that could affect glucose measurements or glucose management. 8. Female subject who is pregnant or planning to become pregnant within the planned study duration |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Schneider Children's Medical center | Petaach-Tikva | |
Slovenia | University Children's Hospital | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center | Medtronic |
Israel, Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time spent in the normal range | increase in the time spent in the normal range, defined as sensor glucose level within 70-180 mg/dl | during each 6 days iteration | No |
Secondary | number of iterations required to achieve the maximal meaningful improvement in the primary outcome | number of iterations required to achieve the maximal meaningful improvement in the primary outcome | Day 78 | No |
Secondary | time spent above 180 mg/dl | time spent above 180 mg/dl | during each 6 days iteration | No |
Secondary | time spent below 70 mg/dl | time spent below 70 mg/dl | during each 6 days iteration | Yes |
Secondary | Number of Hypoglycemic events below 63 mg/dl | Number of Hypoglycemic events below 63 mg/dl | during each 6 days iteration | Yes |
Secondary | Adverse event | Adverse event | during each 6 days iteration | Yes |
Secondary | glucose variability- area under the curve | glucose variability measured as area under the curve (the area between the measured blood glucose and the glucose level of 180 mg/dl) and area above the curve (the area between the measured blood glucose and the glucose level of 70 mg/dl | during each 6 days iteration | No |
Secondary | Quality of Life Questionaires | Quality of Life Questionaires | At the end of the study- day 30 -78 | No |
Secondary | Number of MDLAP-recommendations that were rejected by the physician | Number of MDLAP-recommendations that were rejected by the physician | during each 6 days iteration | No |
Secondary | Number and type of changes in any pump setting per iteration | Number and type of changes in any pump setting per iteration | during each 6 days iteration | No |
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