Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)

Study Overview
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Brief Summary
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Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.

Official Title
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Open-label, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Associated With a Continuous Glucose Monitoring System Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)

Conditions
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Type1diabetes

Intervention / Treatment
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* Device: InPen Medtronic
* Device: Minimed 780G system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic criteria for DM1 according to ADA Candidates for both systems (closed loop or smart insulin pen) for their usual healthcare team. Acceptance of participation in the study and signing of the informed consent Exclusion Criteria: Gestation Institutionalization, serious or terminal illness or renal replacement therapy. Inability to undertake the training and / or acquire the degree of knowledge to use both systems Refusal to participate in the study or to sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Closed loop system<br>Minimed 780G (Medtronic) | Device: InPen Medtronic<br>* Patients with DM1 ≥ 18 years of age who initiate Inpen system.<br>|
| Experimental: SmartPen<br>InPen (Medtronic) | Device: Minimed 780G system<br>* Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range | To assess the difference on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c levels | To assess the differences in serum A1c levels (%) | 12 months | 
| Time below range | To assess the difference on the glycemic control expressed as time in below range (% of time < 70 mg/dl of interstitial glucose). | 12 months | 
| Time above range | To assess the difference on the glycemic control expressed as time in above range (% of time >180 mg/dl of interstitial glucose). | 12 months | 
| Health-Related Quality of Life in Patients with Type 1 Diabetes | Assess health-related quality of life in patients with type 1 diabetes (by ViDa1 questionnaire).ViDa1 questionnaire has four-dimensional structure: Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. | 12 months |