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

NCT02617160 | Terminated

• 1 other identifier: RMC059315ctil
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of glucose readings within range of 70-180 mg/dl

  Day 90 for segments A and C and day 30 for segment B

Secondary Outcomes (4)

• Percentage of glucose readings below 60 mg/dl

  Day 90 (for segments A and C only)

• HbA1c levels

  Day 90 (for segments A and C only)

• Percentage of glucose readings below 54 mg/dl

  Day 30 for segment B and Day 90 for segment C

• Percentage of glucose readings below 50 mg/dl

  Day 30 (for segment B only)

Other Outcomes (14)

• The percentage of glucose readings below 70 mg/dl

  Day 90 for segments A and C and Day 30 for segment B

• The percentage of glucose readings above 240 mg/dl

  Day 90 for segments A and C and day 30 for segment B

• The percentage of glucose readings above 180

  Day 90 for segments A and C and day 30 for segment B

Study Arms (2)

MD Logic Pump Advisor

EXPERIMENTAL

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

Device: MD-Logic Pump Advisor

Control Group-Medical guided recommendations

ACTIVE COMPARATOR

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

Other: Control Group

Interventions

MD-Logic Pump Advisor 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

MD Logic Pump Advisor

Control Group 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

Control Group-Medical guided recommendations

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead
• Novo Nordisk A/S: collaborator
• DreaMed: collaborator

Study Sites (1)

Schneider Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Moshe Phillip, MD, Prof

  Rabin Medical Center

  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: November 23, 2015
• First Posted: November 30, 2015
• Study Start: May 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

IL (1)