Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
NCT ID:
NCT05168657
Description:
Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
Frequency Threshold:
0
Time Frame:
Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant.
Study:
NCT05168657
Study Brief:
Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PC Pre-randomization | Random-order cross-over participants managed by PRIMARY CARE who were not yet randomized. | 0 | None | 0 | 20 | 5 | 20 | View |
| EN Pre-randomization | Random-order cross-over participants managed by ENDOCRINOLOGY who were not yet randomized. | 0 | None | 2 | 20 | 2 | 20 | View |
| PC-TH-BP | Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. | 0 | None | 0 | 10 | 2 | 10 | View |
| EN-IP-UC | Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes. | 0 | None | 1 | 10 | 2 | 10 | View |
| EN-TH-UC | Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes. | 0 | None | 0 | 10 | 3 | 10 | View |
| EN-TH-BP | Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. | 0 | None | 0 | 10 | 0 | 10 | View |
| PC Between Arms | Participants had up to 14 days from the stop of Arm 1 to schedule the start of Arm 2. This was not a washout period. | 0 | None | 0 | 20 | 0 | 20 | View |
| EN Between Arms | Participants had up to 14 days from the stop of Arm 1 to schedule the start of Arm 2. This was not a washout period. | 0 | None | 0 | 19 | 1 | 19 | View |
| EN-IP-BP | Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. | 0 | None | 0 | 9 | 0 | 9 | View |
| PC-IP-BP | Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. | 0 | None | 0 | 10 | 2 | 10 | View |
| PC-TH-UC | Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes. | 0 | None | 0 | 10 | 1 | 10 | View |
| PC-IP-UC | Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes. | 0 | None | 0 | 10 | 0 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Sinus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Illness/Cold/Flu | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Carpal tunnel surgery | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Dermatofibroma | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Cataract Surgery | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |