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Evaluating the Smart MDI system for managing type 1 diabetes

Smart MDI Randomized Controlled Trial in Subjects With Type 1 Diabetes (Smart MDI Study)

Not applicable Interventional Medtronic Diabetes · NCT06645834

This study is testing if the Smart MDI system can help people with type 1 diabetes manage their condition better than traditional insulin injections combined with glucose monitoring.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment140 (estimated)
Ages2 Years and up
SexAll
SponsorMedtronic Diabetes Industry-sponsored
Locations18 sites (Antwerpen and 17 other locations)
Trial IDNCT06645834 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of the Smart MDI system, which includes InPen™ and Simplera™, compared to traditional Multiple Daily Injection (MDI) therapy with intermittent scanning or real-time Continuous Glucose Monitoring (isCGM/CGM) over a period of 6 months. It is a post-market, prospective, open-label, multi-center, randomized controlled trial involving both adult and pediatric participants with type 1 diabetes. The study includes a 3-week run-in phase to gather baseline data before participants are randomized to either continue their current therapy or switch to the Smart MDI system. Approximately 140 subjects will be enrolled across 20 investigational centers in Europe.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 2 years and older who have been on MDI therapy for at least 6 months and have a clinical diagnosis of type 1 diabetes.

Not a fit: Patients who are not on MDI therapy or those with a HbA1c below 8% may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective management option for patients with type 1 diabetes, potentially improving their glycemic control.

How similar studies have performed: Other studies have shown promise in using advanced insulin delivery systems, suggesting that this approach may lead to meaningful improvements in diabetes management.

Eligibility criteria

Show full inclusion / exclusion 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 \<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.

Where this trial is running

Antwerpen and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 1
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.