Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

Study Overview
=================
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.

Detailed Description
-----------------
This study is a single-center, single arm study in adult subjects with type 1 diabetes utilizing AHCL System with meal gesture detection and micro dosing (meal gesture dosing). Meal gesture dosing is a mode whereby meal announcements are not entered manually by the user. Instead, when meal gesture dosing is active, meal announcements are generated automatically by the system based on the detection of eating gestures and micro doses of insulin are given. Overall subject participation will be approximately 3 weeks to 6 months. A total of up to 40 subjects (aged 18-75) may be enrolled at one investigational center in Israel to have at least 16 subjects complete the study. The study consists of a run-in period and a study period. The run-in period is intended to allow subjects to become familiar with using the study pump system with the SmartGuard feature active and wearing the watch. Subjects should use the same insulin they will be using during the study period. During the first week of the study period, subjects will undergo a 5-day at-home baseline meal challenge at specific meals on each day. The Klue app will be set to monitoring-mode. After run-in period and completion of the 5-day at-home study period with baseline meal challenges, study subjects will check into the clinic for a 5-day (4 nights) intervention. Study subjects will wear the system with Klue meal gesture dosing activated for the entire duration of the 5-day intervention.

Official Title
-----------------
Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgement Is using pramlintide (Symlin), DPP-4 inhibitor, GLP-1 agonists (as liraglutide (Victoza or other), metformin, SGLT2 inhibitors (as canagliflozin (Invokana)) at time of screening Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator Is diagnosed with current eating disorder such as anorexia or bulimia Has been diagnosed with chronic kidney disease that results in chronic anemia Is on dialysis Is a member of the research staff involved with executing the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: meal gesture dosing for unannounced meals within the AHCL System<br> | Device: MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Hybrid Closed Loop, Meal Gesture Dosing, Klue™ Health App