MD Logic Pump Advisor- Adults Study

NCT01157923 | Completed

• 1 other identifier: rmc005816ctil
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief Summary

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).

Conditions

Type 1 Diabetes; Insulin Pump Therapy

Keywords

Type 1 diabetes; Insulin Pump Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• number of iterations required to achieve the maximal meaningful improvement in the primary outcome

  Day 78

• time spent above 180 mg/dl

  during each 6 days iteration

• time spent below 70 mg/dl

  during each 6 days iteration

• Number of Hypoglycemic events below 63 mg/dl

  during each 6 days iteration

• Adverse event

  during each 6 days iteration

Study Arms (2)

intervantion group

EXPERIMENTAL

Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor.

Device: MD Logic Pump Advisor

control group

NO INTERVENTION

Regular treatment, No change will be made in the insulin pump setting during the study(unless there is a medical need or any safety concern).

Interventions

MD Logic Pump Advisor DEVICE

Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor

intervantion group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with Type 1 diabetes (\>1yr since diagnosis)
• Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
• Age ≥ 18 years
• No concomitant diseases that influence metabolic control
• No current use of CGM
• Subjects do not participate in any other interventional study

You may not qualify if:

• Known or suspected allergy to trial products.
• 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
• Subject is currently using CGM device
• Diabetic ketoacidosis in the past 3 months.
• Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
• Current use of oral glucocorticoids or 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 planning to become pregnant within the planned study duration

Sponsors & Collaborators

• Rabin Medical Center: lead
• Medtronic: collaborator

Study Sites (2)

Schneider Children's Medical center

Petaach-Tikva, 49202, Israel

Location

University Children's Hospital

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshe Phillip, Prof

  Schenider Children's Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2010
• First Posted: July 7, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2016-01

Locations

SL (1); IL (1)