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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Closed loop system Minimed 780G (Medtronic) |
Device: InPen Medtronic
Patients with DM1 ≥ 18 years of age who initiate Inpen system.
|
| Experimental: SmartPen InPen (Medtronic) |
Device: Minimed 780G system
Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system.
|
Outcome Measures
Primary Outcome Measures
- Time in Range [12 months]
To assess the difference on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose).
Secondary Outcome Measures
- A1c levels [12 months]
To assess the differences in serum A1c levels (%)
- Time below range [12 months]
To assess the difference on the glycemic control expressed as time in below range (% of time < 70 mg/dl of interstitial glucose).
- Time above range [12 months]
To assess the difference on the glycemic control expressed as time in above range (% of time >180 mg/dl of interstitial glucose).
- Health-Related Quality of Life in Patients with Type 1 Diabetes [12 months]
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.
Eligibility Criteria
Criteria
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:
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Gestation
-
Institutionalization, serious or terminal illness or renal replacement therapy.
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Inability to undertake the training and / or acquire the degree of knowledge to use both systems
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Refusal to participate in the study or to sign the informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Ramón y Cajal | Madrid | Spain | 28034 |
Sponsors and Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Investigators
- Principal Investigator: Lía Nattero-Chávez, MD.PhD, Hospital Ramón y CajaDiabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 189/22