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Completed

NCT Number: NCT04271228

Use of Insulin Adjustment Device DreaMed Advisor Pro During Routine Clinical Use for Subjects With Diabetes Type 1

The DreaMed Advisor Pro, is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing (FDA approved decision support system). The Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), 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. The algorithm is designed as an advisory tool for health care professionals and has three main components: First, data analysis report - a statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemic patterns. Second, recommendations, alert messages based on aforementioned data for example "pay attention- you skipped boluses", basal/bolus ratio is too high, bolus delivery compliance, glucose target recommendations and more. Third, a recommendation for new insulin pump settings: including basal intervals and rate, different carbohydrate ratio according to time of day, correction factor and insulin sensitivity time. The Advisor Pro can be used to optimize insulin pump setting during clinical visits, in-between visits or as part of virtual (telemedicine) visit. The objective of the proposed study is to evaluate the use of Advisor Pro by Health Care Providers for regular clinical visits and in between visits titration for adjustment of insulin pump settings. The study design is an open label, prospective, observational study that will include up to 100 participants with Type 1 Diabetes using insulin pumps and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schnider Children's Medical Center

Petah Tikva, 4920235, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented Type 1 Diabetes for at least 1 year prior to study enrolment
  • Subjects aged 6 - 65 years old
  • HbA1c at inclusion ≤ 10%
  • Subjects using Insulin pump therapy for at least 4 months
  • Subjects using Insulin pump compatible with data transmission to the study Tidepool/Glooko Data Managment System (DMS) - Omnipod, Medtronic
  • Subjects using Continuous Glucose Monitoring (CGM) System that is compatible with data transmission to the study Tidepool/Glooko DMS - Dexcom, Libre, Medtronic.
  • Subjects willing to follow study instructions: Use CGM according to manufacture instructions, use the bolus-wizard feature of the insulin pump for every meal and correction boluses.
  • Subjects have home PC or MAC connected to the internet.
  • Subjects willing and able to sign a written informed consent form.

Exclusion criteria

  • An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment.
  • Concomitant diseases/ treatment that influence metabolic control or any significant diseases /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's safety.
  • Relevant severe organ disorders (diabetic nephropathy, diabetic retinopathy, diabetic foot syndrome) or any secondary disease or complication of diabetes mellitus, such as:
  • Subject has unstable or rapidly progressive renal disease or is receiving dialysis
  • Subject has active proliferative retinopathy
  • Active gastroparesis
  • Participation in any other interventional study
  • Female subject who is pregnant or planning to become pregnant within the planned study duration
  • Subject is in the "honeymoon" phase - i.e. less than 0.5 insulin units/kg per day.
  • Known or suspected allergy to trial products
  • Drug or alcohol abuse

Treatment and study plan

DreaMed Advisor Pro

Device

Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use

Primary outcomes

  1. HbA1c

    Time frame: Through study completion , an average of 1 year

Secondary outcomes

  1. Percentage of glucose readings within target range of 70-180 mg/dl

    Time frame: Through study completion, an average of 1 year

  2. Percentage of glucose sensor readings below 54 mg/dl

    Time frame: Through study completion, an average of 1 year

  3. Percentage of glucose sensor readings above 250 mg/dl

    Time frame: Through study completion, an average of 1 year

  4. Percentage of glucose sensor readings 70-54 mg/dl

    Time frame: Through study completion, an average of 1 year

  5. Percentage of glucose sensor readings 180-250 mg/dl

    Time frame: Through study completion, an average of 1 year

  6. Mean sensor glucose

    Time frame: Through study completion, an average of 1 year

  7. Glucose variability

    Time frame: Through study completion, an average of 1 year

  8. Total insulin dose

    Time frame: Through study completion, an average of 1 year

  9. Total basal insulin dose

    Time frame: Through study completion, an average of 1 year

  10. Total Bolus insulin dose

    Time frame: Through study completion, an average of 1 year

  11. Total daily consumed carbohydrates

    Time frame: Through study completion, an average of 1 year

Other outcomes

  1. Number of recommendations for changes in the treatment plan per patient

    Time frame: Through study completion, an average of 1 year

  2. Number of physician overrides of advisor recommendations

    Time frame: Through study completion, an average of 1 year

  3. Device satisfaction

    Time frame: at the end of the intervention period (1 year)

    Device satisfaction evaluated by Healthcare Professionals Survey containing 50 items, Device satisfaction evaluated by Healthcare Professionals Survey containing 50 items, 28 of them are on 5-point scale ranging from "strongly agree" to "strongly disagree", 10 items are "yes"/ "no" questions and 12 items are opened questions.

  4. Frequency of home phone visits

    Time frame: Through study completion, an average of 1 year

  5. Time required to review insulin pump and sensor data, make and send recommendations or length of visit

    Time frame: Through study completion, an average of 1 year

    will be measured by timer

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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