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Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Advanced Hybrid Closed Loop, Meal Gesture Dosing, Klue™ Health App

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:
1. Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
2. Coma
3. 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.

Sites / Locations

Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

meal gesture dosing for unannounced meals within the AHCL System

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04964128

First Posted

July 6, 2021

Last Updated

September 1, 2023

Sponsor

Medtronic Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT04964128

Brief Title

Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

Official Title

Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

July 22, 2021 (Actual)

Primary Completion Date

June 10, 2022 (Actual)

Study Completion Date

July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

meal gesture dosing for unannounced meals within the AHCL System

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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.

Title

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

Description

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

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Sheba Medical Center

City

Tel Hashomer

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

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Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

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