Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 diabetes mellitus, Automated insulin delivery, Omnipod 5, Hybrid Closed Loop, Continuous Glucose Monitoring, Real-world evidence, Diabetes technology
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.
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.
Interventions
None listed
Sponsors
Papa Giovanni XXIII Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Range (70-180 mg/dL) | Baseline, approximately 6 months. approximately 12 months, and approximately 18 months after starting therapy with the Omnipod 5 system. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 glycated hemoglobin (HbA1c) from baseline to approximately 6, 12, and 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 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. |
| 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 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. |
| 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 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. |
| 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. | 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. |
| Change from baseline in the number of participants experiencing at least one episode of severe hypoglycemia | 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. |
| Change from baseline in the total number of severe hypoglycemia episodes | 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. |
| Change from baseline in the number of participants experiencing at least one episode of diabetic ketoacidosis | 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. |
| Change from baseline in the total number of diabetic ketoacidosis episodes | 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. |
Countries
Italy
Contacts
STUDY_DIRECTORNicolò Borella, MD
Endocrine Disease and Diabetes Unit, ASST Papa Giovanni XXIII Bergamo, Italy
Outcome results
None listed