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Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT04964128
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) Not Applicable

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.

The study period will be approximately 10 days long, but overall subject participation will be approximately 4 weeks.

A total of up to 20 subjects (aged 18-75) may be enrolled at one investigational center in Israel to have at least 8 subjects complete the study.

The study consists of a run-in period and a study period. The first 2 weeks of the run-in period is intended to allow subjects to become familiar with using the study pump system with the SmartGuard feature 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 one specific meal on each day. The Klue app will be set to monitoring-mode. After run-in period and completion of the 1 week 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes
Actual Study Start Date : July 22, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
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)
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 Measures :
  1. Percentage of Time in Range [ Time Frame: 1 month ]
    Overall mean percentage of Post-prandial Time in range (% of SG within 70-180 mg/dL) at home and In-Clinic Period will be summarized, respectively.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04964128


Contacts
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Contact: Roseline Re +33684520425 roseline.re@medtronic.com
Contact: Linda Vorrink + 41 79 865 8140 linda.vorrink@medtronic.com

Locations
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Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Amir Tirosh    +972-3-5307822    Amir.Tirosh@sheba.health.gov.il   
Sponsors and Collaborators
Medtronic Diabetes
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT04964128    
Other Study ID Numbers: CIP339
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
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
Keywords provided by Medtronic Diabetes:
Advanced Hybrid Closed Loop
Meal Gesture Dosing
Klue™ Health App
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs