Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

NCT04964128 | Completed Results FDA Device

• 1 other identifier: CIP339
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this feasibility study is to evaluate subject safety of using the Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) within the AHCL system in adult subjects with type 1 diabetes in a clinic setting.

Conditions

Type 1 Diabetes

Keywords

Advanced Hybrid Closed Loop; Meal Gesture Dosing; Klue™ Health App

Outcome Measures

Primary Outcomes (2)

• Percentage of Time in Range (Phase 1, Software Release Tag 1.0)

  Overall mean percentage of Post-prandial Time in range (% of SG within 70-180 mg/dL) at home and In-Clinic Period during Phase 1

  Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic). The time in range metrics are considered in a 4 hours window after each of the test meals.

• Percentage of Time in Range (Phase 2, Software Release Tag 2.0)

  Overall mean percentage of Post-prandial Time in range (% of SG within 70-180 mg/dL) at home and In-Clinic Period during Phase 2

  Overall subject participation lasted approximately 3 weeks to 6 months, which included a 5 day at-home and a 5-day in-clinic period. The time in range metrics are considered in a 4 hours window after each of the test meals.

Study Arms (1)

meal gesture dosing for unannounced meals within the AHCL System

EXPERIMENTAL

Device: MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)

Interventions

MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) DEVICE

The AHCL system with Meal Gesture Dosing evaluated in this study includes a commercial/CE-Marked insulin pump with investigational software, and the Klue Health mobile app with investigational software (installed on Apple Watch) for meal gesture detection and micro dosing.

meal gesture dosing for unannounced meals within the AHCL System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is age 18-75 years at time of screening
• Has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via source documentation
• Pump therapy for greater than 6 months prior to screening
• Real-time continuous glucose monitoring (RT-CGM) experience greater than 3 months prior to screening
• Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
• Is willing to perform ≥2 fingerstick blood glucose measurements daily
• Is willing to perform required sensor calibrations
• Is willing to wear the system continuously throughout the study
• If subject has celiac disease, it has been adequately treated as determined by the investigator
• If the subject has had any of the following cardiovascular events more than 1 year prior to of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances they should be cleared by a cardiologist prior to participation, if deemed necessary by the investigator.
• If the subject has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances, they should be cleared by a cardiologist prior to participation.
• Is of legal age and capable of providing consent
• Is fluent in speaking, reading and understanding English

You may not qualify if:

• Has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening:
• Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
• Coma
• Seizures
• Has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
• Has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
• Is unable to tolerate tape adhesive in the area of sensor placement
• Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
• Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study
• Women who are breastfeeding
• Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
• Is being treated for hyperthyroidism at time of Screening
• Has a diagnosis of adrenal insufficiency
• Is using hydroxyurea at time of screening or plans to use it during the study
• Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related Publications (1)

• Roy A, Grosman B, Benedetti A, Engheta B, Miller D, Laron-Hirsh M, Cohen Y, Re R, Edd SN, Vigersky R, Cohen O, Tirosh A. An Automated Insulin Delivery System with Automatic Meal Bolus Based on a Hand-Gesturing Algorithm. Diabetes Technol Ther. 2024 Sep;26(9):633-643. doi: 10.1089/dia.2023.0529. Epub 2024 Mar 12.

  PMID: 38417017 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Roseline Re
• Organization: Medtronic

roseline.re@medtronic.com

+33684520425

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: July 22, 2021
• Primary Completion: June 10, 2022
• Study Completion: July 26, 2022
• Last Updated: September 13, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)