Diabetes Mellitus, Type 1NCT04823312
Evaluation of Medtronic DUO Extended Set
A study testing Experimental prospective single arm evaluating the Medtronic Duo Extended Set in people with Diabetes Mellitus, Type 1, run by Atlanta Diabetes Associates at 1 site in United States.
Trial summary
This study is a single-center, non-randomized, prospective single arm study of adult subjects with type 1 diabetes utilizing 670G insulin pump therapy with Continuous Glucose Monitoring (CGM). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Experimental prospective single arm evaluating the Medtronic Duo Extended Set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 1 Nov 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has type 1 diabetes for more than one year.
- Subject is on the MiniMed 670G insulin pump therapy within1 year prior to screening.
- Subject is currently using Auto Mode at least 75% of the time and willing to utilize Auto Mode and Duo device during the study.
- Subject is willing and able to perform study procedures as per investigator discretion.
- Subject is willing to take one of the following two insulins: Humalog or Novolog
Who cannot join
- 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.
- Subject is female and has a positive pregnancy screening test.
- Subject is female of childbearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator.
- Subject is female and plans to become pregnant during the study.
- Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening.
- Subject has had a history of 1 or more episodes of severe hypoglycemia.
Show all 23Show fewer
- Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
- Subject is unable to tolerate tape adhesive in the area of Duo™ Extended set or sensor.
- Subject has any unresolved adverse skin condition, including infection, in the area of Duo™ Extended set or sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
- Subject is currently abusing illicit drugs.
- Subject is currently abusing alcohol.
- Subject has history of adrenal disorder.
- Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening.
- Subject has any condition that the Investigator believes would interfere with study participation.
- Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
- Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
- Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
- Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening.
- Subject has been diagnosed with chronic kidney disease, having an estimated glomerular filtration rate (eGFR)< 60mL/min/1.73 m2, requiring dialysis, or resulting in chronic anemia.
- Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
- Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit.
- Subject plans to have medical imagining (e.g., MRI, diathermy services, CT scans, etc.) over the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Melody L Cantrell, PharmD, 404-355-4393 ext. 850, mcantrell@atlantadiabetes.com
Betsy Childs, RN, 404-355-4393, bchilds@atlantadiabetes.com
About this study
Official title: Early Feasibility Study: Evaluation of Medtronic Duo Extended Set With 670G Pump Therapy
This study is a single-center, non-randomized, prospective single arm study of adult subjects with type 1 diabetes utilizing 670G insulin pump therapy with Continuous Glucose Monitoring (CGM). These subjects will be using 4 DUO Extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.
Read the detailed description
Up to 20 adult subjects will be enrolled at the research center. Atlanta Diabetes Associates (ADA), with at least 15 subjects meeting the eligibility criteria. Eligibility criteria will be assessed at the screening visit and confirmed prior to Visit 2. At Visit 2, subjects will be provided supplies, including the DUO device, and will be trained on insertion. Each subject will wear their own MiniMed 670G insulin system including Guardian sensor (new sensor with transmitter will be provided for the study) and a DUO Extended set. The infusion set in the DUO Extended will be used for insulin infusion and the sensor in the DUO Extended will be blinded with a specific recorder connected to each sensor.
Guardian Sensor (3) and the SMBG measurements will be used for making therapy decisions as approved for the 670G system. Subjects will upload their pump, Contour meter and GS3 sensor data each week, which will be reviewed by an investigator. Subjects will wear the DUO device for a total of four weeks. At Visit 6, subjects will come to the site to have devices uploaded, to return the investigational devices, to have a skin assessment and for labs to be drawn.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Experimental prospective single arm evaluating the Medtronic Duo Extended Set
- Keywords
- Diabetes Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental prospective single arm evaluating the Medtronic Duo Extended SetDevice
Also called Medtronic DUO Extended Set with 670G Pump Therapy
Subjects will be using 4 Duo extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Duo Extended Set | Experimental | These subjects will be using 4 Duo Extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set. Receives: Device: Experimental prospective single arm evaluating the Medtronic Duo Extended Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Duo Extended set failures due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Unexplained hyperglycemia
Measured: 7 days
Secondary outcomes (1)
Number of subjects with a rate of infusion set survival of 7 days or greater, excluding those that kinked on insertion or accidentally pulled out.
Infusion set survival
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start18 Mar 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlanta Diabetes Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Bruce W Bode, MD, Principal investigator, Atlanta Diabetes Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823312
- Sponsor's protocol ID
- ADA-001
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study: Evaluation of Medtronic Duo Extended Set With 670G Pump Therapy
- ClinicalTrials.gov ID
- NCT04823312
- Acronym / sponsor ID
- ADA-001
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Atlanta Diabetes AssociatesUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 30 Mar 2021 (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.
This study is a single-center, non-randomized, prospective single arm study of adult subjects with type 1 diabetes utilizing 670G insulin pump therapy with Continuous Glucose Monitoring (CGM). These subjects will be using 4 DUO Extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.
Detailed description
Up to 20 adult subjects will be enrolled at the research center. Atlanta Diabetes Associates (ADA), with at least 15 subjects meeting the eligibility criteria. Eligibility criteria will be assessed at the screening visit and confirmed prior to Visit 2. At Visit 2, subjects will be provided supplies, including the DUO device, and will be trained on insertion. Each subject will wear their own MiniMed 670G insulin system including Guardian sensor (new sensor with transmitter will be provided for the study) and a DUO Extended set. The infusion set in the DUO Extended will be used for insulin infusion and the sensor in the DUO Extended will be blinded with a specific recorder connected to each sensor.
Guardian Sensor (3) and the SMBG measurements will be used for making therapy decisions as approved for the 670G system. Subjects will upload their pump, Contour meter and GS3 sensor data each week, which will be reviewed by an investigator. Subjects will wear the DUO device for a total of four weeks. At Visit 6, subjects will come to the site to have devices uploaded, to return the investigational devices, to have a skin assessment and for labs to be drawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medtronic Duo Extended Set | Experimental | Device: Experimental prospective single arm evaluating the Medtronic Duo Extended SetThese subjects will be using 4 Duo Extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has type 1 diabetes for more than one year.
- Subject is on the MiniMed 670G insulin pump therapy within1 year prior to screening.
- Subject is currently using Auto Mode at least 75% of the time and willing to utilize Auto Mode and Duo device during the study.
- Subject is willing and able to perform study procedures as per investigator discretion.
- Subject is willing to take one of the following two insulins: Humalog or Novolog
Key exclusion criteria (23 listed)
- 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.
- Subject is female and has a positive pregnancy screening test.
- Subject is female of childbearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator.
- Subject is female and plans to become pregnant during the study.
- Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental prospective single arm evaluating the Medtronic Duo Extended SetAlso: Medtronic DUO Extended Set with 670G Pump TherapySubjects will be using 4 Duo extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set. | Device | Medtronic Duo Extended Set |
Primary outcome
Number of subjects with Duo Extended set failures due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Time frame: 7 days
Unexplained hyperglycemia
1 secondary outcome
Number of subjects with a rate of infusion set survival of 7 days or greater, excluding those that kinked on insertion or accidentally pulled out.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Bruce W Bode, MD principal investigator
Atlanta Diabetes Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental prospective single arm evaluating the Medtronic Duo Extended Set in people with Diabetes Mellitus, Type 1, run by Atlanta Diabetes Associates 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 5 inclusion and 23 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 30 Mar 2021. 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 Melody L Cantrell, PharmD (404-355-4393 ext. 850, mcantrell@atlantadiabetes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Duo Extended set failures due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2021.