Diabetes Mellitus, Type 1NCT01973413
Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
A study testing Diabetes Assistant (DiAs), Tandem t:slim Insulin Pump and Dexcom G4 Platinum sensor in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
Trial summary
The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data. Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Diabetes Assistant (DiAs), Tandem t:slim Insulin Pump and Dexcom G4 Platinum sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2013
- 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 10 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and a Medtronic, Animas or Tandem insulin infusion pump for at least 3 months
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide levels and antibody determinations are not required.
- Age 10.0 - 35 years
- Willingness to use a Sure-T or Contact Detach infusion set while at camp
Who cannot join
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- Using an OmniPod insulin infusion pump
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
Show all 16Show fewer
- Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- History of ongoing renal disease (other than microalbuminuria).
- Insulin pump users who supplement with injected intermediate or long acting insulin.
- Subjects who take other anti-diabetic medications other than insulin..
- Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal disorder
- Abuse of alcohol
- Pregnancy (verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned).
- Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.
Read the detailed description
The first phase of this study will test the feasibility of initializing the DiAs CTR system in a clinical research center. We will test the procedures that will occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We will also test how the system performs using the same calibration and blood glucose monitoring that will be done at camp. In the inpatient study we will mimic some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies will be reviewed by the Data Safety Monitoring Board (DSMB) before we proceed with the Phase 2 summer camp studies.
The second phase of this proposal is the "in-camp" studies. The same health care providers that conducted the inpatient studies will be conducting the camp studies. They will be monitoring all campers on closed-loop control in real-time. Participants will be randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Those assigned to DiAs CTR control will be remotely monitored throughout the night. Those assigned to the control group will not have remote monitoring overnight, but they will be wearing a Dexcom G4Platinum sensor with active low and high sensor glucose alarms. Initial studies will be done at a camp with older children and camp staff who are aged 15-35 years of age, with at least 5 subjects between 15 to 18 years old. If these studies are safe (after DSMB review) we will do additional camps and include children 10-14 years old.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Diabetes Assistant (DiAs), Tandem t:slim Insulin Pump, Dexcom G4 Platinum sensor
- Keywords
- Artificial Pancreas Project, Diabetes Mellitus, Type 1, Insulin pump therapy, Continuous Glucose Monitors (CGM), Juvenile-Onset Diabetes, Autoimmune Diabetes, Closed-to-Range, Diabetes Assistant (DiAs)
- 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.
Diabetes Assistant (DiAs)Device
The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range.
Tandem t:slim Insulin PumpDevice
FDA, market-approved insulin pump.
Dexcom G4 Platinum sensorDevice
FDA, market-approved continuous glucose monitor (CGM)
| Study group | Role | What they receive |
|---|---|---|
| Closed-Loop Control with DiAs System | Experimental | Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time. Receives: Device: Diabetes Assistant (DiAs); Device: Tandem t:slim Insulin Pump; Device: Dexcom G4 Platinum sensor |
| Control Group, Sensor-Augmented Pump Therapy | Placebo comparator | Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring. Receives: Device: Tandem t:slim Insulin Pump; Device: Dexcom G4 Platinum sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Time Near Normoglycemia
Percent of time in a glucose target range of 70-150 mg/dl during camp study.
Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group.
Measured: 6 nights
Secondary outcomes (2)
Overnight Glucose
Mean overnight glucose during camp study.
Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group.
Measured: 6 nights
Glycemic Events
Number of nights with >= 1 hypo- and hyperglycemic event occurring overnight during the camp study.
Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group.
Measured: 6 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionAug 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Marc Breton, University of Virginia
- Investigators
- Bruce Buckingham, MD, Principal investigator, Stanford UniversityMarc Breton, PhD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973413
- Sponsor's protocol ID
- 001-Stanford
- Status last verified
- Apr 2015
- First submitted
- 24 Oct 2013
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ly TT, Breton MD, Keith-Hynes P, De Salvo D, Clinton P, Benassi K, Mize B, Chernavvsky D, Place J, Wilson DM, Kovatchev BP, Buckingham BA. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Care. 2014 Aug;37(8):2310-6. doi: 10.2337/dc14-0147. Epub 2014 May 30.
PubMed 24879841
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Assistant (DiAs) Control-to-Range (CTR) Nocturnal Closed-Loop Camp Study
- ClinicalTrials.gov ID
- NCT01973413
- Acronym / sponsor ID
- 001-Stanford
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Artificial Pancreas Project, Diabetes Mellitus, Type 1, Insulin pump therapy, Continuous Glucose Monitors (CGM), Juvenile-Onset Diabetes, Autoimmune Diabetes, Closed-to-Range, Diabetes Assistant (DiAs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.
Detailed description
The first phase of this study will test the feasibility of initializing the DiAs CTR system in a clinical research center. We will test the procedures that will occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We will also test how the system performs using the same calibration and blood glucose monitoring that will be done at camp. In the inpatient study we will mimic some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies will be reviewed by the Data Safety Monitoring Board (DSMB) before we proceed with the Phase 2 summer camp studies.
The second phase of this proposal is the "in-camp" studies. The same health care providers that conducted the inpatient studies will be conducting the camp studies. They will be monitoring all campers on closed-loop control in real-time. Participants will be randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Those assigned to DiAs CTR control will be remotely monitored throughout the night. Those assigned to the control group will not have remote monitoring overnight, but they will be wearing a Dexcom G4Platinum sensor with active low and high sensor glucose alarms. Initial studies will be done at a camp with older children and camp staff who are aged 15-35 years of age, with at least 5 subjects between 15 to 18 years old. If these studies are safe (after DSMB review) we will do additional camps and include children 10-14 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-Loop Control with DiAs System | Experimental | Device: Diabetes Assistant (DiAs), Device: Tandem t:slim Insulin Pump, Device: Dexcom G4 Platinum sensorSubjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time. |
| Control Group, Sensor-Augmented Pump Therapy | Placebo comparator | Device: Tandem t:slim Insulin Pump, Device: Dexcom G4 Platinum sensorSubjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring. |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and a Medtronic, Animas or Tandem insulin infusion pump for at least 3 months
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide levels and antibody determinations are not required.
- Age 10.0 - 35 years
- Willingness to use a Sure-T or Contact Detach infusion set while at camp
Key exclusion criteria (16 listed)
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- Using an OmniPod insulin infusion pump
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
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 |
|---|---|---|
| Diabetes Assistant (DiAs)The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range. | Device | Closed-Loop Control with DiAs System |
| Tandem t:slim Insulin PumpFDA, market-approved insulin pump. | Device | Closed-Loop Control with DiAs System, Control Group, Sensor-Augmented Pump Therapy |
| Dexcom G4 Platinum sensorFDA, market-approved continuous glucose monitor (CGM) | Device | Closed-Loop Control with DiAs System, Control Group, Sensor-Augmented Pump Therapy |
Primary outcome
Percent Time Near Normoglycemia
Time frame: 6 nights
Percent of time in a glucose target range of 70-150 mg/dl during camp study. Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group.
2 secondary outcomes
Overnight Glucose
Time frame: 6 nights
Glycemic Events
Time frame: 6 nights
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24879841Ly TT, Breton MD, Keith-Hynes P, De Salvo D, Clinton P, Benassi K, Mize B, Chernavvsky D, Place J, Wilson DM, Kovatchev BP, Buckingham BA. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Care. 2014 Aug;37(8):2310-6. doi: 10.2337/dc14-0147. Epub 2014 May 30.
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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 Buckingham, MD principal investigator
Stanford University
Marc Breton, PhD principal investigator
University of Virginia Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Assistant (DiAs), Tandem t:slim Insulin Pump and Dexcom G4 Platinum sensor in people with Diabetes Mellitus, Type 1, 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 4 inclusion and 16 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 24 Apr 2015. 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. Some participants in this study may receive a placebo. 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 15 Aug 2014). 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?
Percent Time Near Normoglycemia (time frame: 6 nights). 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 NCT01973413, 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 24 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.