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Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
NA trial testing Insulin Pump with Continuous Glucose Monitoring in Type 1 Diabetes in 250 participants. Completed in 29 December 2023.
| Lead sponsor | Medtronic MiniMed, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 28 February 2023 |
| Primary completion | 29 December 2023 |
| Estimated completion | 29 December 2023 |
| Sites | 23 locations across United States |
Medtronic MiniMed, Inc.
Adults 7 to 80, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
| Group | Value | 95% CI |
|---|---|---|
| Subjects 7-17 Years of Age | -0.4 | ± 0.8 |
| Subjects 18-80 Years of Age | -0.7 | ± 0.7 |
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
| Group | Value | 95% CI |
|---|---|---|
| Subjects 7-17 Years of Age | 71.4 | ± 9.9 |
| Subjects 18-80 Years of Age | 80.2 | ± 8.1 |
The mean % of time in hypoglycemia (\< 54 mg/dL) . Non-inferiority test.
| Group | Value | 95% CI |
|---|---|---|
| Subjects 7-17 Years of Age | 0.4 | ± 0.3 |
| Subjects 18-80 Years of Age | 0.2 | ± 0.4 |
The mean % of time in range (TIR 70-180 mg/dL ).Superiority test.
| Group | Value | 95% CI |
|---|---|---|
| Subjects 7-17 Years of Age | 71.4 | ± 9.9 |
| Subjects 18-80 Years of Age | 80.2 | ± 8.1 |
Time frame: 3 month Study period. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Subjects 7-17 Years of Age | Subjects 18-80 Years of Age |
|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | — | — |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | — | — |
| Reaction | System | Subjects 7-17 Years of Age | Subjects 18-80 Years of Age |
|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Infusion site infection | Infections and infestations | — | — |
| Viral infection | Infections and infestations | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Gastritis | Gastrointestinal disorders | — | — |
| Medical device site haemorrhage | General disorders | — | — |
| Medical device site reaction | General disorders | — | — |
| COVID-19 | Infections and infestations | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Localised infection | Infections and infestations | — | — |
| Otitis externa | Infections and infestations | — | — |
| Ligament sprain | Injury, poisoning and procedural complications | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Postural orthostatic tachycardia syndrome | Cardiac disorders | — | — |
| Retinal detachment | Eye disorders | — | — |
| Retinopathy | Eye disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Gastrointestinal disorder | Gastrointestinal disorders | — | — |
| Irritable bowel syndrome | Gastrointestinal disorders | — | — |
| Oral pain | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Illness | General disorders | — | — |
| Influenza like illness | General disorders | — | — |
| Infusion site dermatitis | General disorders | — | — |
| Infusion site haemorrhage | General disorders | — | — |
| Infusion site pain | General disorders | — | — |
| Infusion site rash | General disorders | — | — |
| Infusion site reaction | General disorders | — | — |
| Medical device site dermatitis | General disorders | — | — |
| Medical device site pain | General disorders | — | — |
| Medical device site pruritus | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Allergy to arthropod bite | Immune system disorders | — | — |
| Hypersensitivity | Immune system disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Conjunctivitis | Infections and infestations | — | — |
| Cystitis | Infections and infestations | — | — |
| Folliculitis | Infections and infestations | — | — |
Most-reported serious reactions: Hypoglycaemia, Diabetic ketoacidosis.
Data from ClinicalTrials.gov NCT05714059 adverse events section.
The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 diabetes adult and pediatric subjects in a home setting.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing