Type 1 DiabetesNCT04964128

Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

A study testing MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Type 1 Diabetes
What is being tested?: MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteIsrael
Study dates: 22 Jul 2021to 26 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Sheba Medical Center
Tel HaShomer

Other trials in Israel

About this study

Read the 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.

Conditions: Type 1 Diabetes
Being tested: MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)
Keywords: Advanced Hybrid Closed Loop, Meal Gesture Dosing, Klue™ Health App
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04964128
Study group	Role	What they receive
meal gesture dosing for unannounced meals within the AHCL System	Experimental	Not described Receives: Device: MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 202126 Jul 2022

First posted15 Jul 2021
Study start22 Jul 2021
Primary completion10 Jun 2022
Study completion26 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04964128
Sponsor's protocol ID: CIP339
Status last verified: Sep 2023
First submitted: 6 Jul 2021
Last updated: 13 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 38417017

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04964128
Acronym / sponsor ID: CIP339
Conditions: Type 1 Diabetes
Keywords: Advanced Hybrid Closed Loop, Meal Gesture Dosing, Klue™ Health App
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: 22 Jul 2021 (actual)
Primary completion: 10 Jun 2022 (actual)
Study completion: 26 Jul 2022 (actual)
First posted: 15 Jul 2021 (actual)
Results: Posted 3 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
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)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (22 listed)

Has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening:
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)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.	Device	meal gesture dosing for unannounced meals within the AHCL System

Primary outcome

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

Results and safety

Results posted to the registry on 3 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)	18	17

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

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.. Mean (Standard Deviation). Unit: percentage of time

Measure	At-Home n = 17	In-Clinic n = 17
Meal 1 (Large Meal with Low Carbohydrate Count)	76.1 (28.7)	84.3 (14.9)
Meal 2 (Small Meal with High Carbohydrate Count)	65.5 (35.7)	48 (28.1)
Meal 3 (Typical Meal Size with Medium Carbohydrate Count)	70 (33.5)	70.9 (27.4)
Meal 4 (Typical Meal Size with High Carbohydrate Count)	63.9 (28.8)	27.3 (12.2)
Meal 5 (Typical Meal Size with Low Carbohydrate Count)	82.7 (25)	73.5 (30.5)

Population analysed: Number of participants only includes those that had data available

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

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.. Mean (Standard Deviation). Unit: percentage of time

Measure	At-Home n = 17	In-Clinic n = 17
Meal 1 (Long Meal with Low Carbohydrate Count)	76.8 (26.5)	88.2 (16)
Meal 2 (Large Meal with Low Carbohydrate Count)	81 (30.8)	73.7 (33)
Meal 3 (Small Meal with High Carbohydrate Count)	62.7 (20.2)	59.9 (26.8)
Meal 4 (Large Drink with No Carbohydrates)	91.9 (14.1)	84.3 (18.1)
Meal 5 (Typical Meal Size with Medium Carbohydrate Count)	91.8 (10.8)	76.4 (26.9)
Meal 6 (Long Meal with High Carbohydrates)	74.2 (25.9)	62.8 (33)
Meal 7 (Large Drink with High Carbohydrate)	74.8 (16.5)	67.8 (25.6)
Meal 8 (Typical Meal Size with Low Carbohydrate Count)	86.4 (15.2)	90.8 (14.2)

Population analysed: Number of participants only includes those that had data available

Adverse events

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 (Software Release Tag 1.0)	1 of 18 (5.6%)	1 of 18 (5.6%)	0 of 18
Phase 2 (Software Release Tag 2.0)	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38417017Roy 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time in Range (Phase 1, Software Release Tag 1.0) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04964128, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.