Type 1 Diabetes MellitusNCT03674281
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
A study testing SAP and CLC in people with Type 1 Diabetes Mellitus and Cognitive Change, run by University of Virginia at 1 site in United States.
Trial summary
The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Cognitive Change
- What is being tested?
- SAP and CLC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year, using insulin for at least 1 year and using an insulin pump for at least 6 months.
- Familiarity and use of a carbohydrate ratio for meal boluses by participants and families participating.
- Age 6-10 years old or 65 years or older
- Hemoglobin A1c <10%
- For females of child-bearing potential, not currently known to be pregnant:
- A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
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- For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
- Willing to disable any automated insulin delivery functionality on a personal insulin pump during study, such as Medtronic 670G in auto mode. Predictive low blood glucose suspend, such as Tandem insulin pump with Basal-IQ, will be allowed.
- Investigator has confidence that the participant and family can successfully operate all study devices and is capable of adhering to the protocol.
- Willingness to switch to lispro (Humalog) or aspart (Novolog) and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
- Total daily insulin dose (TDD) at least 10 U/day.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
Who cannot join
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
- Diagnosis of Diabetic Ketoacidosis in the 12 months prior to enrollment.
- Uncontrolled cardiac disease (e.g. recent myocardial infarction, severe congestive heart failure).
- Cerebrovascular accident in the 12 months prior to enrollment.
- Uncontrolled resting arterial hypertension (>160/90 mm Hg).
- Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility).
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- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.
Read the detailed description
This study will evaluate up to 15 subjects in each age group for a period of 8-10 weeks performing neurocognitive tests before and after each intervention. The first study phase will be up to 2 weeks of a training period to allow participants to get acquainted with the use of the CGM if they are not familiar with the use of the device. This training period will be followed by a 4-week sensor-augmented pump (SAP) period using a study CGM and the subject's personal insulin pump. The subjects will return to clinic at the completion of the SAP period and will be trained on the Tandem t:slim X2 with Control-IQ and G6 CGM. At the completion of the system training session, subjects will begin 4-weeks of Closed-Loop Control (CLC). Questionnaires will be completed by the study subject at screening, after completion of SAP and after completion of CLC. Ecological Momentary Assessments (EMAs) and actigraphy data will be collected in the last 14 days of the SAP and CLC periods.
A parent/guardian of the enrolled children will also be asked to participate in all trainings, complete parental Patient-Report Outcomes (PRO) Questionnaires, and collect sleep patterns while wearing the actigraph watch.
- Conditions
- Type 1 Diabetes Mellitus, Cognitive Change
- Being tested
- SAP, CLC
- Keywords
- Closed-Loop Control (CLC), Sensor-Augmented Therapy (SAP), Insulin Pump, Artificial Pancreas (AP), Continuous Glucose Monitor (CGM)
- 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.
SAPDevice
Also called Sensor-augmented Pump
Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
CLCDevice
Also called Tandem t:slim X2 with Control-IQ and Dexcom G6 CGM
The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.
| Study group | Role | What they receive |
|---|---|---|
| Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC) | Experimental | SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period. Receives: Device: SAP; Device: CLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time of Blood Glucose in Range 70-180 mg/dL
Percentage of time of blood glucose in range 70-180 mg/dL as measured by the continuous glucose monitor.
Measured: One month during each study period (sensor augmented pump and closed loop control)
Secondary outcomes (2)
Ecological Momentary Assessments
Positive Moods were assessed using Ecological Momentary Assessments. Participants were asked a question on positive moods and answered on a Likert scale from 0 to 4 with a higher score indicating more positive mood. Scores were averaged from all evaluable completed assessment that were completed in the final 14 days of each study period.
Measured: Assessments will be administered during the final 14 days of each study period (sensor-augmented pump and closed-loop control).
Sleep Patterns
Pittsburgh Sleep Quality Index (PSQI): a 10-item questionnaire assessment of sleep quality disturbances over the last month. Individual Items are rated on a 4 point Likert scale ranging from 0 to 3, which are then used to calculate a Global Score which can range from 0 to 21 with higher scores reflecting worse sleep quality. Parents completed the questionnaire for the young children cohort.
Measured: Assessments will be made at baseline and at the end of each study SAP (4 weeks) and CLC (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start24 Sep 2018
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Research Investment Fund, DexCom, Inc., Tandem Diabetes Care, Inc.
- Responsible party
- Principal investigator, Sue Brown, University of Virginia
- Investigators
- Sue Brown, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674281
- Sponsor's protocol ID
- 20964
- Other IDs
- VRIF-FY18-002
- Status last verified
- Dec 2020
- First submitted
- 14 Sep 2018
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
- ClinicalTrials.gov ID
- NCT03674281
- Acronym / sponsor ID
- 20964
- Conditions
- Type 1 Diabetes Mellitus, Cognitive Change
- Keywords
- Closed-Loop Control (CLC), Sensor-Augmented Therapy (SAP), Insulin Pump, Artificial Pancreas (AP), Continuous Glucose Monitor (CGM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Virginia Research Investment Fund, DexCom, Inc., Tandem Diabetes Care, Inc.
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.
Detailed description
This study will evaluate up to 15 subjects in each age group for a period of 8-10 weeks performing neurocognitive tests before and after each intervention. The first study phase will be up to 2 weeks of a training period to allow participants to get acquainted with the use of the CGM if they are not familiar with the use of the device. This training period will be followed by a 4-week sensor-augmented pump (SAP) period using a study CGM and the subject's personal insulin pump. The subjects will return to clinic at the completion of the SAP period and will be trained on the Tandem t:slim X2 with Control-IQ and G6 CGM. At the completion of the system training session, subjects will begin 4-weeks of Closed-Loop Control (CLC). Questionnaires will be completed by the study subject at screening, after completion of SAP and after completion of CLC. Ecological Momentary Assessments (EMAs) and actigraphy data will be collected in the last 14 days of the SAP and CLC periods.
A parent/guardian of the enrolled children will also be asked to participate in all trainings, complete parental Patient-Report Outcomes (PRO) Questionnaires, and collect sleep patterns while wearing the actigraph watch.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC) | Experimental | Device: SAP, Device: CLCSAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period. CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year, using insulin for at least 1 year and using an insulin pump for at least 6 months.
- Familiarity and use of a carbohydrate ratio for meal boluses by participants and families participating.
- Age 6-10 years old or 65 years or older
- Hemoglobin A1c <10%
- For females of child-bearing potential, not currently known to be pregnant:
Key exclusion criteria (12 listed)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
- Diagnosis of Diabetic Ketoacidosis in the 12 months prior to enrollment.
- Uncontrolled cardiac disease (e.g. recent myocardial infarction, severe congestive heart failure).
- Cerebrovascular accident in the 12 months prior to enrollment.
- Uncontrolled resting arterial hypertension (>160/90 mm Hg).
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 |
|---|---|---|
| SAPAlso: Sensor-augmented PumpSubjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6). | Device | Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC) |
| CLCAlso: Tandem t:slim X2 with Control-IQ and Dexcom G6 CGMThe Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM. | Device | Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC) |
Primary outcome
Percentage of Time of Blood Glucose in Range 70-180 mg/dL
Time frame: One month during each study period (sensor augmented pump and closed loop control)
Percentage of time of blood glucose in range 70-180 mg/dL as measured by the continuous glucose monitor.
2 secondary outcomes
Ecological Momentary Assessments
Time frame: Assessments will be administered during the final 14 days of each study period (sensor-augmented pump and closed-loop control).
Sleep Patterns
Time frame: Assessments will be made at baseline and at the end of each study SAP (4 weeks) and CLC (4 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
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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.
Sue Brown, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAP and CLC in people with Type 1 Diabetes Mellitus and Cognitive Change, run by University of Virginia 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 12 Jan 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?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time of Blood Glucose in Range 70-180 mg/dL (time frame: One month during each study period (sensor augmented pump and closed loop control)). 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 12 Jan 2021.