Type 1 Diabetes MellitusNCT04329871
Medtronic 670G Insulin Pump and the Impact on Glycemic Control, Quality of Life, and Compliance
An observational study of Type 1 Diabetes Mellitus, run by Metabolic Research Institute, Inc. at 1 site in United States.
Trial summary
Analyze the Medtronic 670g pump on glycemic control Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2020to 23 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who enter the study at Visit 1 and meet all the inclusion criteria and none of the exclusion criteria will be eligible to sign informed consent to have their data collected and analyzed
Who may be able to join
- age 18 or older
- Documented History of Type 1 Diabetes Mellitus
- 3 months continuous use of the Medtronic 670g pump system
- given written informed consent
Who cannot join
- Less than 3 months use of the Medtronic 670g pump system
- Taking any other medication, other than the insulin used in the Medtronic 670g pump, to manage their diabetes
- having medical conditions or taking medications that would preclude subject involvement or affect the outcomes being measured, in the opinion of the Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Metabolic Research Institute
West Palm Beach, Florida, 33401
Paula Dear, 561-802-3060 ext. 8045, pdear@metabolic-institute.com
Adriana Donadio, 561-802-3060 ext. 8033, adonadio@metabolic-institute.com
About this study
Official title: An Analysis of Medtronic 670G Insulin Pump Use in Clinical Practice and the Impact on Glycemic Control, Quality of Life, and Compliance
Analyze the Medtronic 670g pump on glycemic control
Read the detailed description
An Analysis of the Medtronic 670g Insulin pump use in clinical practice and the impact on glycemic control , quality of life, and compliance
- Conditions
- Type 1 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control while using the Medtronic MiniMed 670g system
HbA1c, fructosamine, and glycomark will be compared between the participants last visit on previous insulin therapy and the last visit using the pump
Measured: through study completion, an average of 1 year.
Secondary outcomes (1)
Efficacy of Quality of Life and satisfaction while using the MiniMed 670g system
Diabetes Treatment Satisfaction, Diabetes-dependent Quality of Life, and Pump QOL vs Previous Therapy Questionnaires will be completed by each study participant
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start24 Mar 2020
- Primary completion23 Mar 2021 (estimated)
- Study completion23 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metabolic Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry S Horowitz, MD, Principal investigator, Metabolic Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329871
- Sponsor's protocol ID
- MetabolicRI
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An article will be written and submitted in a major journal.
Publications
There are no Citations
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Medtronic 670G Insulin Pump Use in Clinical Practice and the Impact on Glycemic Control, Quality of Life, and Compliance
- ClinicalTrials.gov ID
- NCT04329871
- Acronym / sponsor ID
- MetabolicRI
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Metabolic Research Institute, Inc.University, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 23 Mar 2021 (estimated)
- Study completion
- 23 Mar 2021 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analyze the Medtronic 670g pump on glycemic control
Detailed description
An Analysis of the Medtronic 670g Insulin pump use in clinical practice and the impact on glycemic control , quality of life, and compliance
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who enter the study at Visit 1 and meet all the inclusion criteria and none of the exclusion criteria will be eligible to sign informed consent to have their data collected and analyzed
Key inclusion criteria (4 listed)
- age 18 or older
- Documented History of Type 1 Diabetes Mellitus
- 3 months continuous use of the Medtronic 670g pump system
- given written informed consent
Key exclusion criteria (3 listed)
- Less than 3 months use of the Medtronic 670g pump system
- Taking any other medication, other than the insulin used in the Medtronic 670g pump, to manage their diabetes
- having medical conditions or taking medications that would preclude subject involvement or affect the outcomes being measured, in the opinion of the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glycemic control while using the Medtronic MiniMed 670g system
Time frame: through study completion, an average of 1 year.
HbA1c, fructosamine, and glycomark will be compared between the participants last visit on previous insulin therapy and the last visit using the pump
1 secondary outcome
Efficacy of Quality of Life and satisfaction while using the MiniMed 670g system
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- BackgroundThere are no Citations
- Company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. An article will be written and submitted in a major journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry S Horowitz, MD principal investigator
Metabolic Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Metabolic Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula M Dear (561-802-3060 ext. 8045, pdear@metabolic-institute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control while using the Medtronic MiniMed 670g system (time frame: through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04329871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.