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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
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
|Contact: Roseline Reemail@example.com|
|Contact: Linda Vorrink||+ 41 79 865 firstname.lastname@example.org|
|Sheba Medical Center||Recruiting|
|Tel Hashomer, Israel|
|Contact: Amir Tirosh +972-3-5307822 Amir.Tirosh@sheba.health.gov.il|