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Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
NA trial testing Insulin Pump in Type 1 Diabetes in 151 participants. Completed in 1 February 2021.
| Lead sponsor | Medtronic MiniMed, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 151 |
| Start date | 18 April 2016 |
| Primary completion | 28 November 2018 |
| Estimated completion | 1 February 2021 |
| Sites | 11 locations across United States, Israel |
Medtronic MiniMed, Inc.
Adults 2 to 13, 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.
Descriptive analysis of change in A1C from baseline to end of 3-month study period
| Group | Value | 95% CI |
|---|---|---|
| Age 2-13 Years Old Wearing MMT-670G Insulin Pump | -0.37 | ± 0.62 |
mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months study period
| Group | Value | 95% CI |
|---|---|---|
| Age 2-13 Years Old Wearing the MMT-670G Insulin Pump | 8.58 | ± 8.84 |
mean change in % of time in hyperglycemia (\> 180 mg/dL) from baseline to 3 months study period
| Group | Value | 95% CI |
|---|---|---|
| Age 2-13 Years Old Wearing the MMT-670G Insulin Pump | -7.39 | ± 9.96 |
mean change in % of time in hypoglycemia (\< 70 mg/dL) from baseline to 3 months study period
| Group | Value | 95% CI |
|---|---|---|
| Age 2-13 Years Old Wearing the MMT-670G Insulin Pump | -1.19 | ± 2.58 |
Number of severe hypoglycemic events occurred during 3-month study period.
| Group | Value | 95% CI |
|---|---|---|
| Age 2-13 Years Old Wearing the MMT-670G Insulin Pump | 0 |
Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period.
| Group | Value | 95% CI |
|---|---|---|
| Age 2-13 Years Old Wearing the MMT-670G Insulin Pump | 0 |
Event rate without Hypoglycemia at YSI-FST \<=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST \<= 65mg/dL during in-clinic procedures.
| Group | Value | 95% CI |
|---|---|---|
| Age 7-13 Years Old Wearing the MMT-670G Insulin Pump | 84.8 |
Time frame: 3 months for Study period, up to 3 years for Continued Access period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Age 2-13 Yrs Study Period | Age 2-13 Yrs Continued Acc… |
|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Hypoglycaemic seizure | Nervous system disorders | — | — |
| Reaction | System | Age 2-13 Yrs Study Period | Age 2-13 Yrs Continued Acc… |
|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Pharyngitis streptococcal | Infections and infestations | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Viral infection | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Pyrexia | General disorders | — | — |
| Conjunctivitis | Infections and infestations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Ear infection | Infections and infestations | — | — |
| Gastroenteritis viral | Infections and infestations | — | — |
| Sinusitis | Infections and infestations | — | — |
| Viral upper respiratory tract infection | Infections and infestations | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — |
| Infusion site infection | Infections and infestations | — | — |
| Otitis media | Infections and infestations | — | — |
| Otitis media acute | Infections and infestations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Skin irritation | Skin and subcutaneous tissue disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Coeliac disease | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Ligament sprain | Injury, poisoning and procedural complications | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Concussion | Injury, poisoning and procedural complications | — | — |
| Hand fracture | Injury, poisoning and procedural complications | — | — |
| Hand-foot-and-mouth disease | Infections and infestations | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — | — |
| Eczema | Skin and subcutaneous tissue disorders | — | — |
| Gastrointestinal viral infection | Infections and infestations | — | — |
| Humerus fracture | Injury, poisoning and procedural complications | — | — |
| Influenza like illness | General disorders | — | — |
| Medical device site infection | Infections and infestations | — | — |
Most-reported serious reactions: Hyperglycaemia, Diabetic ketoacidosis, Gastroenteritis, Hypoglycaemic seizure.
Data from ClinicalTrials.gov NCT02660827 adverse events section.
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm is safe as part of the overall system, and to assess the PLGM feature in 7-13 years old subjects.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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