Real-world Effectiveness and Safety of Omnipod 5 in Adults With Type 1 Diabetes: a 12-month Observational Study.
July 8, 2026 updated by: Giuseppe Lepore, Papa Giovanni XXIII Hospital
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Automated insulin delivery systems have demonstrated significant improvements in glycemic outcomes in randomized clinical trials. However, evidence from routine clinical practice remains essential to evaluate effectiveness across broader patient populations and routine care settings.
This retrospective observational cohort study will include consecutive adults with type 1 diabetes who initiated treatment with the Omnipod® 5 Automated Insulin Delivery System during routine clinical practice at ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.
Clinical and continuous glucose monitoring (CGM) data routinely collected during clinical follow-up will be extracted from medical records. Glycemic outcomes obtained before initiation of Omnipod 5 will be compared with those recorded after approximately six, twelve and eighteen months of system use.
The primary objective is to evaluate changes in Time in Range (70-180 mg/dL). Secondary objectives include assessment of HbA1c, Time Above Range, Time Below Range, glycemic variability, the proportion of participants achieving recommended international CGM targets; the prevalence of acute diabetes complications (severe hypoglycemia, diabetic ketoacidosis); and rates and causes of system dropout.
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Italy
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Bergamo, Italy, Italy, 20126
- ASST Papa Giovanni XXIII Bergamo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Time in Range (70-180 mg/dL)
Time Frame: Baseline, approximately 6 months. approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HbA1c (mmol/mol or %)
Time Frame: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
|
Change in glycated hemoglobin (HbA1c) from baseline to approximately 6, 12, and 18 months after starting therapy with the Omnipod 5 system.
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Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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Change in Time Below Range Level 1 (54-69 mg/dL)
Time Frame: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
|
Change from baseline in Time Below Range Level 1 (54-69 mg/dL), defined as the percentage of time spent in the glucose range 54-69 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.
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Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
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|
Change in Time Below Range Level 2 (<54 mg/dL)
Time Frame: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
|
Change from baseline in Time Below Range Level 2 (<54 mg/dL), defined as the percentage of time spent with glucose values <54 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.
|
|
Change in Time Above Range Level 1 (>180 mg/dL)
Time Frame: 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 from baseline in Time Above Range Level 1 (181-250 mg/dL), defined as the percentage of time spent in the glucose range181-250 mg/dL, as measured by continuous glucose monitoring (CGM), at approximately 6, 12, and 18 months after initiation of the therapy with the Omnipod 5 system.
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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.
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Change in Time Above Range Level 2 (>250 mg/dL)
Time Frame: Baseline, approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
|
Change from baseline in Time Above Range Level 2 (<250 mg/dL), defined as the percentage of time spent with glucose values >250 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.
|
|
Change from baseline in the number of participants experiencing at least one episode of severe hypoglycemia
Time Frame: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
Change from baseline in the number of participants experiencing at least one episode of severe hypoglycemia during each follow-up period.
Severe hypoglycemia is defined according to the American Diabetes Association as an event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
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Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
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|
Change from baseline in the total number of severe hypoglycemia episodes
Time Frame: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
|
Change from baseline in the total number of severe hypoglycemic episodes occurring during each follow-up period.
Severe hypoglycemia is defined according to the American Diabetes Association as an event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
|
Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system.
|
|
Change from baseline in the number of participants experiencing at least one episode of diabetic ketoacidosis
Time Frame: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
Change from baseline in the number of participants experiencing at least one episode of diabetic ketoacidosis during each follow-up period.
Diabetic ketoacidosis will be identified according to the diagnosis documented in the medical record and standard clinical diagnostic criteria.
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Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
|
Change from baseline in the total number of diabetic ketoacidosis episodes
Time Frame: Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
Change from baseline in the total number of diabetic ketoacidosis episodes occurring during each follow-up period.
Diabetic ketoacidosis will be identified according to the diagnosis documented in the medical record and standard clinical diagnostic criteria.
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Baseline (12 months before initiation of the Omnipod 5 system), approximately 6 months, approximately 12 months, and approximately 18 months after starting of therapy with the Omnipod 5 system.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nicolò Borella, MD, Endocrine Disease and Diabetes Unit, ASST Papa Giovanni XXIII Bergamo, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2026
Primary Completion (Actual)
June 30, 2026
Study Completion (Actual)
June 30, 2026
Study Registration Dates
First Submitted
July 1, 2026
First Submitted That Met QC Criteria
July 8, 2026
First Posted (Actual)
July 10, 2026
Study Record Updates
Last Update Posted (Actual)
July 10, 2026
Last Update Submitted That Met QC Criteria
July 8, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tubeless AID systems
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No individual participant data will be shared because this is a retrospective observational study based on routinely collected clinical data.
The dataset may contain potentially identifiable health information, and the informed consent/ethics approval does not specifically include permission for public sharing of individual-level data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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