Diabetes Mellitus, Type 1NCT02750267
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
A study testing Diabetes Assistant (DiAs) with Closed-Loop in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
Trial summary
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Diabetes Assistant (DiAs) with Closed-Loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2016
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of type 1 diabetes,
- The diagnosis of type 1 diabetes is based on the investigator's judgment
- C peptide levels and antibody determinations are not required
- Daily insulin therapy for ≥ 12 months
- Insulin pump therapy for ≥ 3 months
- Age ≥5 - ≤8 years old
- Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
- Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
Who cannot join
- The presence of any of the following is an exclusion for the study:
- 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)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
Show all 14Show fewer
- Current use of oral 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).
- Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
- Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
- 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 insufficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.
Read the detailed description
Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies. Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues. During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery. However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use). These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings. It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents. In this sense, young children require a device that is not user-centered as much as family-centered. A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Diabetes Assistant (DiAs) with Closed-Loop
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC), Continuous Glucose Monitor, Pediatric, Insulin Pump
- 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) with Closed-LoopDevice
All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission. Receives: Device: Diabetes Assistant (DiAs) with Closed-Loop |
| Group B | Experimental | Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission. Receives: Device: Diabetes Assistant (DiAs) with Closed-Loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Sensor Glucose Readings Between 70-180 mg/dL
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 68 hours
Secondary outcomes (16)
Percent of Time Sensor Glucose Readings Are <70 mg/dL
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 68 hours
Percent of Time Sensor Glucose Readings Are >150 mg/dL
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Percent of Time Sensor Glucose Readings Are >180 mg/dL
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 68 hours
Percent of Time Sensor Glucose Readings Are >250 mg/dL
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 68 hours
Percent of Time Sensor Glucose Readings Are >400 mg/dL
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Distribution of Sensor and Meter Glucose Values (Maximum)
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Distribution of Sensor and Meter Glucose Values (Minimum)
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Mean BG (as Measured by CGM)
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 68 hours
Hypoglycemia Area Under the Curve <60
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Hypoglycemia Area Under the Curve <70 mg/dL
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Hyperglycemia Area Under the Curve >180
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Hyperglycemia Area Under the Curve >250 mg/dL
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
Measured: 68 hours
End of Night Blood Glucose
All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016
- Study completionMay 2016
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Mark DeBoer, MD, University of Virginia
- Investigators
- Mark D. DeBoer, MD, Principal investigator, University of Virginia, Pediatrics, Endocrinology/Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750267
- Sponsor's protocol ID
- 18888
- Status last verified
- Jun 2017
- First submitted
- 15 Apr 2016
- Last updated
- 24 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Not yet determined
Publications
DeBoer MD, Breton MD, Wakeman C, Schertz EM, Emory EG, Robic JL, Kollar LL, Kovatchev BP, Chernavvsky DR. Performance of an Artificial Pancreas System for Young Children with Type 1 Diabetes. Diabetes Technol Ther. 2017 May;19(5):293-298. doi: 10.1089/dia.2016.0424. Epub 2017 Apr 20.
PubMed 28426239
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
- ClinicalTrials.gov ID
- NCT02750267
- Acronym / sponsor ID
- 18888
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC), Continuous Glucose Monitor, Pediatric, Insulin Pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 23 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.
Detailed description
Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies. Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues. During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery. However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use). These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings. It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents. In this sense, young children require a device that is not user-centered as much as family-centered. A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Diabetes Assistant (DiAs) with Closed-LoopIn this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission. |
| Group B | Experimental | Device: Diabetes Assistant (DiAs) with Closed-LoopGroup B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Clinical diagnosis of type 1 diabetes,
- Daily insulin therapy for ≥ 12 months
- Insulin pump therapy for ≥ 3 months
- Age ≥5 - ≤8 years old
- Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
Key exclusion criteria (14 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)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- Cystic fibrosis
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) with Closed-LoopAll subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours. | Device | Group A, Group B |
Primary outcome
Percent of Sensor Glucose Readings Between 70-180 mg/dL
Time frame: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
16 secondary outcomes
Percent of Time Sensor Glucose Readings Are <70 mg/dL
Time frame: 68 hours
Percent of Time Sensor Glucose Readings Are >150 mg/dL
Time frame: 72 hours
Percent of Time Sensor Glucose Readings Are >180 mg/dL
Time frame: 68 hours
Percent of Time Sensor Glucose Readings Are >250 mg/dL
Time frame: 68 hours
Percent of Time Sensor Glucose Readings Are >400 mg/dL
Time frame: 72 hours
Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Time frame: 72 hours
Distribution of Sensor and Meter Glucose Values (Maximum)
Time frame: 72 hours
Distribution of Sensor and Meter Glucose Values (Minimum)
Time frame: 72 hours
Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
Time frame: 72 hours
Mean BG (as Measured by CGM)
Time frame: 68 hours
Hypoglycemia Area Under the Curve <60
Time frame: 72 hours
Hypoglycemia Area Under the Curve <70 mg/dL
Time frame: 72 hours
Hyperglycemia Area Under the Curve >180
Time frame: 72 hours
Hyperglycemia Area Under the Curve >250 mg/dL
Time frame: 72 hours
Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
Time frame: 68 hours
End of Night Blood Glucose
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28426239DeBoer MD, Breton MD, Wakeman C, Schertz EM, Emory EG, Robic JL, Kollar LL, Kovatchev BP, Chernavvsky DR. Performance of an Artificial Pancreas System for Young Children with Type 1 Diabetes. Diabetes Technol Ther. 2017 May;19(5):293-298. doi: 10.1089/dia.2016.0424. Epub 2017 Apr 20.
- Use of an AP in young children was safe and resulted in improved mean BG without increased hypoglycemia. This suggests that AP use in young children is safe and improves overall diabetes control.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Not yet determined
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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.
Mark D. DeBoer, MD principal investigator
University of Virginia, Pediatrics, Endocrinology/Diabetes
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) with Closed-Loop 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 8 inclusion and 14 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 Jul 2017. 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 23 Jun 2017). 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 of Sensor Glucose Readings Between 70-180 mg/dL (time frame: 68 hours). 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 NCT02750267, 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 Jul 2017.