User Evaluation of the MiniMed 620G Insulin Pump
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes Type 2 Diabetes |
Device: Medtronic MiniMed 620G Insulin Pump |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A User Evaluation of the MiniMed® 620G Insulin Pump and Guardian® Link Transmitter |
- Does user acceptance of the new MiniMed 620G insulin pump and Guardian Link transmitter meet expectations? [ Time Frame: Four weeks of pump wear ] [ Designated as safety issue: Yes ]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 and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
- Do the training materials provided with the products meet the needs of the participants? [ Time Frame: One month ] [ Designated as safety issue: No ]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 subject acceptance of the training materials. A response of 4 or greater on the Likert scale will be considered positive for the training materials and indicate acceptance.
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Insulin dependent diabetics
Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G insulin pump and Guardian Link transmitter
|
Device: Medtronic MiniMed 620G Insulin Pump
Subjects to use the Medtronic MiniMed 620G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.
|
Eligibility| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients within the research center diabetes population who currently use insulin pump for their diabetes therapy.
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:
- Has experience and is able to insert/change sensor by herself/himself and
- Has experience and can recharge the transmitter and
- Has experience and can read sensor data in real-time on her/his pump screen
- 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:
- Type 1 diabetes, for a minimum of 6 months prior to enrollment
- Insulin requiring type 2 diabetes, for a minimum of 6 months prior to enrollment
Exclusion Criteria:
- Female subject has a positive urine pregnancy screening test.
- Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
- Subject has any condition that, in the opinion of the Investigator or qualified Investigational Center staff, may preclude him/her from participating in the study and completing study related procedures.
- Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Center staff
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
Contacts and Locations| Australia | |
| St Vincent Hospital and The University of Melbourne | Not yet recruiting |
| Fitzroy, Australia, 3065 | |
| Principal Investigator: David O'Neal | |
| The Royal Melbourne Hospital | Not yet recruiting |
| Patkville, Australia, 3050 | |
| Principal Investigator: Peter Colman | |
| Denmark | |
| Herlev Hospital | Not yet recruiting |
| Herlev, Denmark | |
| Contact: Lise Frost | |
| Principal Investigator: Birthe Susanne Olsen | |
| Spain | |
| Barcelona University Hospital | Not yet recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Xavier Navarro | |
| Principal Investigator: Ignacio Conget | |
| United Kingdom | |
| King's College London | Not yet recruiting |
| London, United Kingdom, SE5 9NU | |
| Contact: Sharon Reid | |
| Principal Investigator: Pratik Choudhary, MBBS, MRCP | |
| University College Hospital | Not yet recruiting |
| London, United Kingdom, NW1 2PG | |
| Contact: Sharon Reid | |
| Principal Investigator: Peter Hindmarsh | |
| Principal Investigator: | Pratik Choudhary, MBBS, MRCP | King's College London |
More Information
No publications provided
| Responsible Party: | Medtronic Diabetes |
| ClinicalTrials.gov Identifier: | NCT01726621 History of Changes |
| Other Study ID Numbers: | CEP267 |
| Study First Received: | November 8, 2012 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013