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CompletedNCT04964128Updated Sep 13, 2023Results posted

Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

An interventional study of MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) in Type 1 Diabetes, sponsored by Medtronic MiniMed, Inc.. Completed at 1 site in Israel. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Medtronic MiniMed, Inc. (part of Medtronic) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Advanced Hybrid Closed Loop
  • Meal Gesture Dosing
  • Klue™ Health App
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 28 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Medtronic MiniMed, Inc. is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

First submitted after Medtronic MiniMed, Inc. became part of Medtronic.

Browse Medtronic MiniMed, Inc. studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Is age 18-75 years at time of screening
  2. Has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via source documentation
  3. Pump therapy for greater than 6 months prior to screening
  4. Real-time continuous glucose monitoring (RT-CGM) experience greater than 3 months prior to screening
  5. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
  6. Is willing to perform ≥2 fingerstick blood glucose measurements daily
  7. Is willing to perform required sensor calibrations
  8. Is willing to wear the system continuously throughout the study
  9. If subject has celiac disease, it has been adequately treated as determined by the investigator
  10. 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.
  11. 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.
  12. Is of legal age and capable of providing consent
  13. Is fluent in speaking, reading and understanding English

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
  3. Has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
  4. Is unable to tolerate tape adhesive in the area of sensor placement
  5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
  6. Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study
  7. Women who are breastfeeding
  8. 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.
  9. Is being treated for hyperthyroidism at time of Screening
  10. Has a diagnosis of adrenal insufficiency
  11. Is using hydroxyurea at time of screening or plans to use it during the study
  12. 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
  13. Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgement
  14. 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
  15. 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
  16. Is diagnosed with current eating disorder such as anorexia or bulimia
  17. Has been diagnosed with chronic kidney disease that results in chronic anemia
  18. Is on dialysis
  19. Is a member of the research staff involved with executing the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    meal gesture dosing for unannounced meals within the AHCL System

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

Interventions

  • DeviceMiniMed™ 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.

06

What researchers measure

Primary outcomes

  1. 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

    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.

  2. 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

    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.

07

Results

Posted Jul 3, 2023

Participant flow

Phase 1 (Software Release Tag 1.0)
Participant flow — Phase 1 (Software Release Tag 1.0)
MilestoneAHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
Started18
Completed17
Not completed1
Withdrew: Withdrawal by subject1
Phase 2 (Software Release Tag 2.0)
Participant flow — Phase 2 (Software Release Tag 2.0)
MilestoneAHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
Started18
Completed17
Not completed1
Withdrew: Physician decision1

Outcome measures

PrimaryPercentage 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

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.
Reported as:
Mean · percentage of time
Percentage of Time in Range (Phase 1, Software Release Tag 1.0)
percentage of timeAt-HomeIn-Clinic
Meal 1 (Large Meal with Low Carbohydrate Count)76.1 ± 28.784.3 ± 14.9
Meal 2 (Small Meal with High Carbohydrate Count)65.5 ± 35.748 ± 28.1
Meal 3 (Typical Meal Size with Medium Carbohydrate Count)70 ± 33.570.9 ± 27.4
Meal 4 (Typical Meal Size with High Carbohydrate Count)63.9 ± 28.827.3 ± 12.2
Meal 5 (Typical Meal Size with Low Carbohydrate Count)82.7 ± 2573.5 ± 30.5
PrimaryPercentage 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

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.
Reported as:
Mean · percentage of time
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
percentage of timeAt-HomeIn-Clinic
Meal 1 (Long Meal with Low Carbohydrate Count)76.8 ± 26.588.2 ± 16
Meal 2 (Large Meal with Low Carbohydrate Count)81 ± 30.873.7 ± 33
Meal 3 (Small Meal with High Carbohydrate Count)62.7 ± 20.259.9 ± 26.8
Meal 4 (Large Drink with No Carbohydrates)91.9 ± 14.184.3 ± 18.1
Meal 5 (Typical Meal Size with Medium Carbohydrate Count)91.8 ± 10.876.4 ± 26.9
Meal 6 (Long Meal with High Carbohydrates)74.2 ± 25.962.8 ± 33
Meal 7 (Large Drink with High Carbohydrate)74.8 ± 16.567.8 ± 25.6
Meal 8 (Typical Meal Size with Low Carbohydrate Count)86.4 ± 15.290.8 ± 14.2

Adverse events

Collected over 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).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 1 (Software Release Tag 1.0)0/18 (0%)1/18 (5.6%)1/18 (5.6%)
Phase 2 (Software Release Tag 2.0)0/18 (0%)0/18 (0%)1/18 (5.6%)
Most frequent serious events
Most frequent serious events
EventPhase 1 (Software Release Tag 1.0)Phase 2 (Software Release Tag 2.0)
Severe HypoglycemiaMetabolism and nutrition disorders1/180/18
Most frequent other events
Most frequent other events
EventPhase 1 (Software Release Tag 1.0)Phase 2 (Software Release Tag 2.0)
IndigestionGastrointestinal disorders1/180/18
Viral infectionInfections and infestations0/181/18
EpididymitisInfections and infestations0/181/18

Baseline characteristics

Overall number of baseline participants reflects all unique subjects participating in phases 1 and 2. There were 8 subjects participating in both phases, so although there were 18 subjects in each phase, there were only 28 unique subjects in the entire study.

Age, Continuous
Age, Continuous(Years)AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
Mean39.4 ± 12.1
Sex: Female, Male
Sex: Female, Male(Participants)AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
Female13
Male15
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
Region of Enrollment
Region of Enrollment(participants)AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
Israel28
08

Study locations

1 site
  • Sheba Medical Center
    Tel Litwinsky, Israel
09

References and documents

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 ↗

Study documents

  • Study protocol · Mar 31, 2022
  • Statistical analysis plan · Jul 11, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Jun 2022, 10 months.

Results were first posted in Jul 2023, 1 year after primary completion.

Of 100 industry-sponsored interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 10 months is close to that.

Counting every sponsor, half of 921 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2021
First posted
Jul 15, 2021
StartActual
Jul 22, 2021
Primary completionActual
Jun 10, 2022
CompletionActual
Jul 26, 2022
Results first posted
Jul 3, 2023
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04964128
Lead sponsor
Medtronic MiniMed, Inc.
Responsible party
Sponsor
First posted
Jul 15, 2021
Start date
Jul 22, 2021
Primary completion
Jun 10, 2022
Completion
Jul 26, 2022
Results posted
Jul 3, 2023
Last update
Sep 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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