Real-world Effectiveness and Safety of Omnipod 5 in Adults With Type 1 Diabetes: a 12-month Observational Study.

NCT07696039 | Completed

• 1 other identifier: Tubeless AID systems
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective observational cohort study aims to evaluate the real-world effectiveness and safety of the Omnipod® 5 Automated Insulin Delivery System in adults with type 1 diabetes receiving routine clinical care at a tertiary diabetes center. Continuous glucose monitoring metrics and glycated hemoglobin values obtained before initiation of Omnipod 5 and approximately after six, twelve and eighteen months of use will be compared to assess changes in glycemic control.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus; Automated insulin delivery; Omnipod 5; Hybrid Closed Loop; Continuous Glucose Monitoring; Real-world evidence; Diabetes technology

Outcome Measures

Primary Outcomes (1)

• Change in Time in Range (70-180 mg/dL)

  Change from baseline in Time in Range (70-180 mg/dL), defined as the percentage of time spent with glucose values within the target glucose range (70-180 mg/dL), as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of therapy with the Omnipod 5 system.

  Baseline, approximately 6 months. approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.

Secondary Outcomes (9)

• Change in HbA1c (mmol/mol or %)

  Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.

• Change in Time Below Range Level 1 (54-69 mg/dL)

  Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.

• Change in Time Below Range Level 2 (<54 mg/dL)

  Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.

• Change in Time Above Range Level 1 (>180 mg/dL)

  Baseline, approximately 6 months, approximately 12 months, and approximately 18 months Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.

• Change in Time Above Range Level 2 (>250 mg/dL)

  Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult individuals with type 1 diabetes treated at the Diabetes Unit of ASST Papa Giovanni XXIII Hospital who initiated Omnipod® 5 as part of routine clinical care.

You may qualify if:

• Adults aged ≥18 years
• Diagnosis of type 1 diabetes
• Initiation of Omnipod® 5 during routine clinical care
• Availability of baseline CGM data
• Availability of at least six-month follow-up CGM data

You may not qualify if:

• Missing baseline CGM data
• Missing follow-up CGM data
• Discontinuation of Omnipod® 5 before outcome assessment
• Other conditions judged by investigators to preclude reliable evaluation

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

ASST Papa Giovanni XXIII Bergamo

Bergamo, Italy, 20126, Italy

Location

Related Publications (3)

• Forlenza GP, DeSalvo DJ, Aleppo G, Wilmot EG, Berget C, Huyett LM, Hadjiyianni I, Mendez JJ, Conroy LR, Ly TT, Sherr JL. Real-World Evidence of Omnipod(R) 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes. Diabetes Technol Ther. 2024 Aug;26(8):514-525. doi: 10.1089/dia.2023.0578. Epub 2024 Feb 16.

  PMID: 38375861 BACKGROUND

• Forlenza GP, Buckingham BA, Brown SA, Bode BW, Levy CJ, Criego AB, Wadwa RP, Cobry EC, Slover RJ, Messer LH, Berget C, McCoy S, Ekhlaspour L, Kingman RS, Voelmle MK, Boyd J, O'Malley G, Grieme A, Kivilaid K, Kleve K, Dumais B, Vienneau T, Huyett LM, Lee JB, O'Connor J, Benjamin E, Ly TT. First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Jun;23(6):410-424. doi: 10.1089/dia.2020.0546. Epub 2021 Jan 18.

  PMID: 33325779 BACKGROUND

• Brown SA, Forlenza GP, Bode BW, Pinsker JE, Levy CJ, Criego AB, Hansen DW, Hirsch IB, Carlson AL, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT; Omnipod 5 Research Group. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care. 2021 Jul;44(7):1630-1640. doi: 10.2337/dc21-0172. Epub 2021 Jun 7.

  PMID: 34099518 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nicolò Borella, MD

  Endocrine Disease and Diabetes Unit, ASST Papa Giovanni XXIII Bergamo, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head of Endocrine Unit

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 10, 2026
• Study Start: January 7, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)