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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02617160
• Other study ID #: RMC059315ctil
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• 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

Other:
• 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

Locations

Country	Name	City	State
Israel	Schneider Medical Center	Petach- Tikva

Sponsors (3)

Lead Sponsor	Collaborator
Rabin Medical Center	DreaMed, Novo Nordisk A/S

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The percentage of glucose readings below 70 mg/dl		Day 90 for segments A and C and Day 30 for segment B
Other	The percentage of glucose readings above 240 mg/dl		Day 90 for segments A and C and day 30 for segment B
Other	The percentage of glucose readings above 180		Day 90 for segments A and C and day 30 for segment B
Other	Number of unexplained hyperglycemic events		Day 90 (segments A and C only)
Other	Area above the curve of 180 mg/dl		Day 90 (Segments A and C only)
Other	Area under the curve of 70 mg/dl		Day 90 (segments A and C only)
Other	Mean sensor blood glucose		Day 90 for segments A and C and day 30 for segment B
Other	Glucose variability measured by Standard Deviation (SD)		Day 90 for segments A and C and day 30 for segment B
Other	Number of recommendations for changes in settings per patient and per iteration		Day 90 for segments A and C and day 30 for segment B
Other	Number of physician override advisor recommendations	Number of physician override advisor recommendations only for the intervention arm during each iteration and for all insulin dose changes	Day 90 for segments A and C and day 30 for segment B
Other	Time duration needed for the physician to give his recommendations		Day 90 (segments A and C only)
Other	Quality of Life Score in QoL Questionnaire		Day 90 (segment A only)
Other	Diabetes Treatment Satisfaction Score in Diabetes Treatment Satisfaction Questionnaire (DTSQ)		Day 90 ( segment A only)
Other	Device Satisfaction	Device Satisfaction evaluated by the Healthcare Professional Survey	Day 30 ( Segment B only)
Primary	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	Percentage of glucose readings below 60 mg/dl		Day 90 (for segments A and C only)
Secondary	HbA1c levels		Day 90 (for segments A and C only)
Secondary	Percentage of glucose readings below 54 mg/dl		Day 30 for segment B and Day 90 for segment C
Secondary	Percentage of glucose readings below 50 mg/dl		Day 30 (for segment B only)