NCT04964128

Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

Completed NA Results posted Last updated 13 September 2023

What this trial tests

NA trial testing MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) in Type 1 Diabetes in 28 participants. Completed in 26 July 2022.

Timeline

22 July 2021

Primary endpoint
10 June 2022

26 July 2022

Quick facts

Lead sponsor	Medtronic MiniMed, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	22 July 2021
Primary completion	10 June 2022
Estimated completion	26 July 2022
Sites	1 location across Israel

Drugs / interventions tested

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

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Medtronic MiniMed, Inc.

Who can join

Adults 18 to 75, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Meal 1 (Large Meal with Low Carbohydrate Count)

Group	Value	95% CI
At-Home	76.1	± 28.7
In-Clinic	84.3	± 14.9

Meal 2 (Small Meal with High Carbohydrate Count)

Group	Value	95% CI
At-Home	65.5	± 35.7
In-Clinic	48	± 28.1

Meal 3 (Typical Meal Size with Medium Carbohydrate Count)

Group	Value	95% CI
At-Home	70	± 33.5
In-Clinic	70.9	± 27.4

Meal 4 (Typical Meal Size with High Carbohydrate Count)

Group	Value	95% CI
At-Home	63.9	± 28.8
In-Clinic	27.3	± 12.2

Meal 5 (Typical Meal Size with Low Carbohydrate Count)

Group	Value	95% CI
At-Home	82.7	± 25
In-Clinic	73.5	± 30.5

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

Meal 1 (Long Meal with Low Carbohydrate Count)

Group	Value	95% CI
At-Home	76.8	± 26.5
In-Clinic	88.2	± 16

Meal 2 (Large Meal with Low Carbohydrate Count)

Group	Value	95% CI
At-Home	81	± 30.8
In-Clinic	73.7	± 33

Meal 3 (Small Meal with High Carbohydrate Count)

Group	Value	95% CI
At-Home	62.7	± 20.2
In-Clinic	59.9	± 26.8

Meal 4 (Large Drink with No Carbohydrates)

Group	Value	95% CI
At-Home	91.9	± 14.1
In-Clinic	84.3	± 18.1

Meal 5 (Typical Meal Size with Medium Carbohydrate Count)

Group	Value	95% CI
At-Home	91.8	± 10.8
In-Clinic	76.4	± 26.9

Meal 6 (Long Meal with High Carbohydrates)

Group	Value	95% CI
At-Home	74.2	± 25.9
In-Clinic	62.8	± 33

Meal 7 (Large Drink with High Carbohydrate)

Group	Value	95% CI
At-Home	74.8	± 16.5
In-Clinic	67.8	± 25.6

Meal 8 (Typical Meal Size with Low Carbohydrate Count)

Group	Value	95% CI
At-Home	86.4	± 15.2
In-Clinic	90.8	± 14.2

Adverse events — posted to ClinicalTrials.gov

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).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1 (Software Release Tag 1.0)

Serious: 1/18 (6%)

Deaths: 0/18

Phase 2 (Software Release Tag 2.0)

Serious: 0/18 (0%)

Deaths: 0/18

Serious adverse events (1 terms)

Reaction	System	Phase 1 (Software Release …	Phase 2 (Software Release …
Severe Hypoglycemia	Metabolism and nutrition disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Phase 1 (Software Release …	Phase 2 (Software Release …
Indigestion	Gastrointestinal disorders	—	—
Viral infection	Infections and infestations	—	—
Epididymitis	Infections and infestations	—	—

Most-reported serious reactions: Severe Hypoglycemia.

Data from ClinicalTrials.gov NCT04964128 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An Automated Insulin Delivery System with Automatic Meal Bolus Based on a Hand-Gesturing Algorithm.
   Roy A, Grosman B, Benedetti A, Engheta B, et al · · 2024 · cited 9× · PMID 38417017 · DOI 10.1089/dia.2023.0529