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This six center international study will include two United Kingdom National Health Service centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The objective of the study is to evaluate subject acceptance of the a new insulin pump and transmitter together with the accompanying training materials. Descriptive data from participant questionnaires and device uploads will be evaluated.
Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of age upwards, who currently use an insulin pump in the management of their type 1 or type 2 diabetes, will be invited to participate. Each subject will be trained on the study device and then use it for approximately six weeks. During this time there will be three in-clinic visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of this period, they will revert back to their original insulin pump and complete a questionnaire on the study pump training materials, features and usability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin dependent diabetics | Other | Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic MiniMed 620G or 640G Insulin Pump | Device | Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter | Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance. | Four weeks of pump wear |
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Inclusion Criteria:
Subject is 7 years or older at time of screening
Subject is current insulin pump user for at least 3 months
Subject has the following Continuous Glucose Monitoring experience as determined by the Investigator:
Subject has signed a Patient Informed Consent form and is willing to comply with the study procedures;
Subject is willing to complete study questionnaires throughout the study
Must have one of the following clinical diagnosis:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pratik Choudhary, MBBS, MRCP | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent Hospital and The University of Melbourne | Fitzroy | 3065 | Australia | |||
| The Royal Melbourne Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Dependent Diabetics | Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Depedent Diabetics | Subject is current insulin pump user and has CGM experience as determined by the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter | Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance. | Posted | Mean | Standard Deviation | units on a scale | Four weeks of pump wear |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Dependent Diabetics | Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter Medtronic MiniMed 620G or 640G Insulin Pump: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding cannula site | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Medtronic MiniMed, Inc | 8185765171 | julie.sekella@medtronic.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Patkville |
| 3050 |
| Australia |
| Herlev Hospital | Herlev | Denmark |
| Barcelona University Hospital | Barcelona | 08036 | Spain |
| University College Hospital | London | NW1 2PG | United Kingdom |
| King's College London | London | SE5 9NU | United Kingdom |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 55 |
| 16 |
| 55 |
| Cough with sputum | Respiratory, thoracic and mediastinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Hyperglycaemia | Endocrine disorders |
|
| Insulin infusion set insertion site - bruising | Skin and subcutaneous tissue disorders |
|
| Ketonemia | Endocrine disorders |
|
| Pyrexia | Immune system disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Severe hypoglycemia | Endocrine disorders |
|
| Skin irritation | Skin and subcutaneous tissue disorders |
|
| Skin irritation from Enlite sensor tape | Skin and subcutaneous tissue disorders |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders |
|
| Urinary infection | Renal and urinary disorders |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |