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Completed

NCT Number: NCT04479826

Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition

The study will follow participants for the periods of 3 months while using an advanced hybrid closed loop algorithm in free living conditions . Each period will have a different meal handling protocols. The objective is to identify the mitigation of the algorithm with different meal handling approaches.

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Key information

Conditions

Type1diabetes

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Tel Litwinsky, Israel

Who can participate

Healthy volunteers accepted: No

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

  • Subject is 20 to 70 years of age at time of screening
  • Subject's weight is between 50 and 120 kg
  • A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
  • Subject has ongoing use of an insulin pump and rtCGM ≥ 6 months prior to screening
  • Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.
  • Subject uses a rapid-acting analogue insulin in his/her pump
  • Patient is willing to undergo all study procedures
  • English proficiency
  • Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units

Exclusion:

  • Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
  • Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
  • Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
  • Subjects currently taking adjunct therapy with SGLT2-inhibitors, GLP-1 mimetics, Amylin.
  • Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
  • Gastroparesis, uncontrolled thyroid disorder, Addison dis. , Pituitary insufficiency
  • Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease within the past 6 months
  • Subject has a presence of a cardiac pacemaker or any other device that may be sensitive to radio frequency telemetry
  • Subject has any condition, including screening lab values that in the opinion of the Investigator may preclude him/her from participating in the study and completing study related procedures
  • Subject is actively participating in other investigational study (drug or device)
  • Subjects who consume alcohol daily

Treatment and study plan

Advanced Hybrid Closed Loop System

Device

Free living follow-up of meal handelling

Primary outcomes

  1. Time in ranges

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2020
Registry last updated
May 12, 2022

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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