Evaluation of Automated Insulin Pump Settings Using the Advisor Pro (Previously Called) MD-Logic Pump Advisor-three Segments Study

NCT ID: NCT02617160

Last Updated: 2018-12-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-12-31

Brief Summary

Pump therapy is gaining popularity as a treatment mode for patients with type 1 diabetes. Utilizing pump therapy requires the development and application of a new spectrum of theoretical knowledge and practical skills by the patient. Furthermore, occasionally there is a need to tailor the pump settings, i.e. the insulin correction factor, carbohydrate ratio, basal plan and insulin activity time, in order to optimize and improve glucose control. These adjustments are based on collected information including insulin delivery, blood glucose measurements, continuous glucose monitoring data, meals and so on. Analyzing this multitude of information and data is overwhelming for many of the patients, caregivers and health care providers. Unfortunately, not all physicians have the needed expertise to fully fulfill this task, and for those who do, it is time consuming. Thus, a summary of the data with insulin dose adjustment suggestions is missing. An automated tool for pump setting adjustments will improve glycemic control without escalating the burden on patients and the health care system. Such advisor can assist the professional team during routine follow-up and the patients between visits.

To address this challenge, the investigators developed the MD-Logic Pump Advisor (MDPA), which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. The MDPA uses information gathered from glucose monitoring, insulin dosing and meal data during daily routine home care. Following a 5 minute data collection and analysis, the algorithm learns and suggests pump-setting changes for optimization of glucose control.

This study aims to evaluate the efficacy and safety of the Advisor Pro. The study will include three segments:

Segment A - a randomized controlled parallel study, Segment B- a clinic prospective study during which the Advisor Pro will be evaluated during routine clinical visits as an added tool for physicians and Segment C- a clinical prospective parallel study for patients treated with pump therapy and SMBG only.

Conditions

Type 1 Diabetes

Keywords

Insulin Pump Treatment; Type 1 Diabetes; Insulin Pump Setting; Pump Advisor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MD Logic Pump Advisor

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

Group Type: EXPERIMENTAL

MD-Logic Pump Advisor

Intervention Type: DEVICE

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

Control Group-Medical guided recommendations

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team in accordance to the regular practice

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team in accordance to the regular practice

Interventions

MD-Logic Pump Advisor

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

Intervention Type: DEVICE

Control Group

Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team in accordance to the regular practice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Documented Type 1 Diabetes for at least 1 year prior to study enrollment
• Segment A:Subjects aged ≥ 10 years and up to 25 years Segment B: Subjects aged ≥ 6 years Segment C: Subjects aged ≥ 6 years and up to 30 years
• HbA1c at inclusion ≤ 11%
• Insulin pump therapy for at least 4 months for segment A and C and at least 3 months for segment B
• BMI Standard Deviation Score - below the 97th percentile for age
• Subjects have continuous glucose monitoring data for at least 2-3 weeks before the clinic regular visit (for segment B only)
• Without routine sensor use (for segment C only)
• Subjects willing to follow study instructions

Exclusion Criteria

• An episode of diabetic keto-acidosis within the month prior to study entry
• Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
• Concomitant diseases/ treatment that influence metabolic control
• Significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
• Participation in any other interventional study
• Known or suspected allergy to trial products
• Female subject who is pregnant or planning to become pregnant within the planned study duration.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

DreaMed

INDUSTRY

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Schneider Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

RMC059315ctil

Identifier Type: -

Identifier Source: org_study_id