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Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
NA trial testing Extended Infusion Set in Diabetes in 291 participants. Completed in 5 November 2020.
| Lead sponsor | Medtronic MiniMed, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 291 |
| Start date | 14 October 2019 |
| Primary completion | 5 November 2020 |
| Estimated completion | 5 November 2020 |
| Sites | 15 locations across United States |
Medtronic MiniMed, Inc.
Adults 18 to 80, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
| Group | Value | 95% CI |
|---|---|---|
| Extended Wear Infusion Set | 0.06 | 0.01 – 0.45 |
Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
| Group | Value | 95% CI |
|---|---|---|
| Extended Wear Infusion Set | 0.27 | 0.10 – 0.71 |
Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
| Group | Value | 95% CI |
|---|---|---|
| Extended Wear Infusion Set | 0.13 | 0.03 – 0.51 |
Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
| Group | Value | 95% CI |
|---|---|---|
| Extended Wear Infusion Set | 0.41 | 0.16 – 1.00 |
Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Humalog Subjects Extended … | Novolog Subjects Extended … |
|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | — | — |
| Tendon rupture | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Humalog Subjects Extended … | Novolog Subjects Extended … |
|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Infusion site discomfort | General disorders | — | — |
| Infusion site cellulitis | Infections and infestations | — | — |
| Infusion site pain | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Infusion site erythema | General disorders | — | — |
| Infusion site swelling | General disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Infusion site bruising | General disorders | — | — |
| Infusion site dermatitis | General disorders | — | — |
| Infusion site infection | Infections and infestations | — | — |
| Infusion site irritation | General disorders | — | — |
| Infusion site nodule | General disorders | — | — |
| Medical device site discomfort | General disorders | — | — |
| Sinusitis | Infections and infestations | — | — |
| Stress | Psychiatric disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Acute sinusitis | Infections and infestations | — | — |
| Blood glucose increased | Investigations | — | — |
| COVID-19 | Infections and infestations | — | — |
| Cataract | Eye disorders | — | — |
| Complication of device removal | General disorders | — | — |
| Conjunctivitis | Infections and infestations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — |
| Diabetic ketosis | Metabolism and nutrition disorders | — | — |
| Ear infection | Infections and infestations | — | — |
| Facial paralysis | Nervous system disorders | — | — |
| Fatigue | General disorders | — | — |
| Folliculitis | Infections and infestations | — | — |
| Foot fracture | Injury, poisoning and procedural complications | — | — |
| Gingivitis | Infections and infestations | — | — |
| Incision site complication | Injury, poisoning and procedural complications | — | — |
| Infusion site haemorrhage | General disorders | — | — |
| Infusion site hypersensitivity | General disorders | — | — |
| Infusion site reaction | General disorders | — | — |
Most-reported serious reactions: Hypoglycemia, Tendon rupture.
Data from ClinicalTrials.gov NCT04113694 adverse events section.
The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing