Clinical trial NCT06645834: Smart MDI Study (CIP343)
Official title: Smart MDI Randomized Controlled Trial in Subjects With Type 1 Diabetes (Smart MDI Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 140
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible subjects must successfully complete the run-in phase by demonstrating tolerance to sensor wear and compliance with study procedures prior to being randomized for the study phase, in which subjects will either be using the InPen™ with InPen™ App and Simplera™ system (Treatment Arm = T) or will continue under their MDI therapy with CGM (Control Arm = C) for another 6 months.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effectiveness of the Smart MDI system with InPen™ and Simplera™ in comparison with Multiple Daily Injection (MDI) therapy with intermittent scanning or real-time Continuous Glucose Monitoring (isCGM/CGM) over 6 months duration in people with type 1 diabetes to support the market access and therapy adoption of the Smart MDI system.

Detailed description: This is a post-market, prospective, open-label, multi-center, randomized controlled trial in adult and pediatric subjects with type 1 diabetes.

The study consists of a run-in phase of 3 weeks and a study phase of 6 months.

The purpose of the run-in phase is to collect baseline HbA1c and CGM data while subjects are on their current therapy.

During the 6-month study phase, subjects will be randomized to continue with their current therapy or to start using the Smart MDI system.

Approximately 140 subjects with type 1 diabetes aged 2 years and older will be enrolled in the study at up to 20 investigational centers in Europe to achieve approximately 112 subjects randomized and completing the 6-month study phase.

Eligibility criteria: Inclusion Criteria:

1. Subject is age 2 years or older at time of screening.
2. Subject is on MDI therapy (defined as ≥ 3 insulin injections per day and on a basal/bolus regimen) ≥ 6 months prior to screening.
3. Subject has a clinical diagnosis of type 1 diabetes for ≥ 12 months.
4. Subject is on MDI therapy with intermittent scanning or Continuous Glucose Monitoring (isCGM/CGM) ≥ 3 months prior to screening.
5. Subject has high compliance with sensor wear, per investigator assessment.
6. Subject has a Glycosylated hemoglobin (HbA1c) ≥ 8% (64 mmol/mol) as assessed locally at time of screening visit.
7. Subject is willing to take or switch to one of the InPen-compatible insulin types, NovoRapid™, Fiasp™, Humalog™ and Lyumjev™.
8. Subject or parent(s)/legal guardian(s) has a compatible mobile phone with Internet access.
9. Subject or parent(s)/legal guardian(s) is willing and able to provide written informed consent, comply with all study procedures and wear all study devices, as required during the study.

Exclusion Criteria:

1. Subject is using a Medtronic InPen™ for at least 3 months prior to screening.
2. Subject has untreated/unstable Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, untreated coeliac disease, untreated thyroid disorder, or poorly controlled asthma, per investigator judgment.
3. Subject is planning to initiate or change to another glucose modifying therapy (for example pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin or SGLT2 inhibitors).
4. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study chronically.
5. Subject has renal failure (stage 4 and above) defined by creatinine clearance of \&lt;30 ml/min, as assessed by Local Lab test ≤ 6 months before screening or performed at screening at Local Lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
6. Subject has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
7. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrollment into this study, as per investigator judgment.
8. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
9. Subject has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
10. Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study.
11. Subject is a woman who is breastfeeding.
12. Subject or parent(s)/legal guardian(s) is legally incompetent, illiterate or a vulnerable person.
13. Subject is a member of the research staff involved with executing the study.

Primary outcomes:
measure: Primary Endpoint
timeFrame: 6-month study period
Secondary outcomes:
measure: Secondary Endpoint 1
timeFrame: 6-month study period
measure: Secondary Endpoint 2
timeFrame: 6-month study period
measure: Secondary Endpoint 3
timeFrame: 6-month study period
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Antwerp University Hospital
city: Brussels
country: Belgium
facility: Hospital Universitaire Bruxelles Erasme
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU Liege
city: Prague
country: Czechia
facility: General University Hospital
city: Prague
country: Czechia
facility: IKEM
city: Brest
country: France
facility: CHRU de Brest service diabetologie endocrinologie
city: Lyon
country: France
facility: Center for DIABeCare, Hospices Civils de Lyon
city: Nimes
country: France
facility: CHU Nimes
city: Toulouse
country: France
facility: Hospital Rangueil
city: Hamburg
country: Germany
facility: Zentrum fur digitale Diabetologie Hamburg
city: Hannover
country: Germany
facility: Hannoversche Kinderheilanstalt
city: Leipzig
country: Germany
facility: MVZ Stoffwechselmedizin Leipzig
city: Bari
country: Italy
facility: University of Bari Aldo Moro
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
city: Vastra Frolunda
country: Sweden
facility: Hogsbo Narsjukhus
Study officials:
References: