Diabetes Mellitus, Type 1NCT01890954
Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents
A study testing Diabetes Assistant (DiAs) in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's ability to significantly improve blood glucose levels when an insulin bolus is omitted for a 30 gram carbohydrate snack and when insulin bolus… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Diabetes Assistant (DiAs)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2014
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≥13 and ≤18 years old
- Clinical diagnosis of type 1 diabetes mellitus for at least 2 years as noted by the following:
- Criteria for documented hyperglycemia (at least 1 criterion must be met):
- Fasting glucose ≥126 mg/dL - confirmed
- Two-hour Oral Glucose Tolerance Test (OGTT) ≥200 mg/dL - confirmed
- Hemoglobin A1c (HbA1c) ≥6.5% documented by history - confirmed
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- Random glucose ≥200 mg/dL with symptoms
- No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):
- Participant required insulin at diagnosis and continually thereafter
- Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually
- Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with Latent Autoimmune Diabetes in Adults (LADA) and did require insulin eventually and used continually
- Use of an insulin pump to treat his/her diabetes for at least 6 months
- Actively using a carbohydrate (CHO) /insulin ratio for insulin bolus adjustments in order to keep blood glucose in a predefined range
- Tanner stage II or greater based on physician exam
- HbA1c between <10.5% as measured with DCA2000 or equivalent device
- Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
- Demonstration of proper mental status and cognition for the study
- Willingness to avoid consumption of acetaminophen-containing products during the study visits involving DexCom use
- Self-reported behavior of snacking without insulin coverage or under bolus for meals
- Willingness to consume a 30 grams snack without insulin coverage and willingness to bolus 75 % of usual treatment for an 80 grams lunch during both admissions
- Willingness to remove home CGM for admissions if the subject typically wears a CGM
- Medication stability in the preceding two months if taking antihypertensive, thyroid, anti-depressant or lipid lowering medication
- Reported history of missed or inaccurate bolus treatments at meal time
Who cannot join
- Diabetic ketoacidosis (DKA) within the 6 months prior to enrollment
- In adherence with the One Touch Ultra 2 User Guide, subjects with hematocrit levels below 30% or above 55% will be excluded. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy; breast feeding, or intention of becoming pregnant
- Uncontrolled arterial hypertension (based on resting blood pressure > 95 percentile as listed according to age and height percentile in the Harriet Lane Handbook of Pediatrics)
- Conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented electrocardiogram (EKG) changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation
- History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
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- History of arrythmia
- Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the DexCom CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
- Anticoagulant therapy other than aspirin
- Oral steroids
- Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for for 24 hours before CGM insertions until the end of each the study admissions.
- Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment)
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Known current or recent alcohol or drug abuse
- Medical conditions that would make operating a CGM, the DiAs cell phone, or insulin pump difficult (e.g. blindness, severe arthritis, immobility)
- Any skin condition that prevents sensor or pump placement on the abdomen or arm (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
- Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥ three times the upper reference limit
- Impaired renal function measured as creatinine >1.2 times above the upper limit of normal
- Uncontrolled microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment
- Active gastroparesis requiring current medical therapy
- Uncontrolled thyroid disease
- Known bleeding diathesis or dyscrasia
- Known allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor
- Active enrollment in another clinical trial
- Use of anti-diabetic agents other than continuous subcutaneous insulin infusion (CSII) including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 agonists and alpha-glucosidase inhibitors
- Subjects with basal rates less than 0.01 units/hour
- RESTRICTIONS ON USE OF OTHER DRUGS OR TREATMENTS
- Use of anti-diabetic agents other than CSII including long-acting insulin, intermediate-acting insulin, metformin, sulfonylureas, meglitinides, thiazolidinediones, DPP-4, inhibitors, glucagon-like peptide 1 agonists, and alpha-glucosidase inhibitors.
- Acetaminophen will be restricted 24 hours before the insertion of not be allowed while the continuous glucose monitor is in use.
- Medications that block symptoms of hypoglycemia, including but not limited to beta blockers.
- Subjects on amylin analogs will be asked to withhold the medication during the outpatient admissions.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22904
About this study
The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's ability to significantly improve blood glucose levels when an insulin bolus is omitted for a 30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of carbohydrates consumed for a meal. The primary objective of this study is to use a closed-loop Control-to-Range (CTR) system to significantly reduce the post-prandial blood glucose excursion in adolescents with type 1 diabetes who omit and/or under-bolus insulin for either snacks or meals. Up to 20 subjects aged ≥13 and ≤18 years old will be tested.
Read the detailed description
The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's ability to significantly improve blood glucose levels when an insulin bolus is omitted for a 30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of carbohydrates consumed for a meal. The CTR system is comprised of two algorithmic layers: (i) A Safety Supervision Module (SSM) which contains a predictive insulin request dampener (or brakes); (ii) a Range Correction Module (RCM), consisting in (a) a Hyperglycemia Mitigation System, and (b) Insulin on Board controller. Both modules will receive continuous glucose monitoring (CGM) and historical insulin delivery data. The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia. The RCM will be responsible for optimizing blood glucose (BG) control and mitigating postprandial hyperglycemic excursions through a mix of increased basal rate and, potentially, isolated insulin boluses. To run CTR, we will use our wearable artificial pancreas platform, known as DiAs (Diabetes Assistant) which consists of a smart phone running CTR and connected to standard insulin delivery and CGM devices.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Diabetes Assistant (DiAs)
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Closed Loop Control (CLC), Diabetes Assistant (DiAs), 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.
Diabetes Assistant (DiAs)Device
Also called Closed-Loop system
Diabetes Assistance (DiAs) is a software residing in a Smartphone that contains the algorithms to regulate and control insulin deliveries (insulin bolus for: Basal rate, meal insulin and correction bolus) with inputs glucose values from a CGM and outputs insulin infusion by an insulin pump
| Study group | Role | What they receive |
|---|---|---|
| DiAs-closed-loop system | Active comparator | eight hours using Closed Loop Control (DiAs) under both, miss insulin bolus for 30 grams of carbohydrates snack or under bolus for an 80 grams of carbohydrates lunch Receives: Device: Diabetes Assistant (DiAs) |
| Sensor Augmented Pump | No intervention | 8 hours observational under both, missed insulin bolus for 30 gr carbohydrates snack and under bolus for an 80 gr carbohydrates lunch. Sensor augmented pump used the patients own insulin settings (basal rate, meal boluses and correction boluses) and a CGM provided by the study team to be used during admission. No DiAs use during this admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Time Spent Near Normoglycemia
Percentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel R. Chernavvsky, MD, CRC, Principal investigator, University of VirginiaMark DeBoer, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890954
- Sponsor's protocol ID
- 16890
- Status last verified
- Aug 2022
- First submitted
- 27 Jun 2013
- Last updated
- 13 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will make de-identified individual participant data (IPD) collected in this study available to other researchers at the end of the study. Paper published in Pediatric Diabetes
Publications
Chernavvsky DR, DeBoer MD, Keith-Hynes P, Mize B, McElwee M, Demartini S, Dunsmore SF, Wakeman C, Kovatchev BP, Breton MD. Use of an artificial pancreas among adolescents for a missed snack bolus and an underestimated meal bolus. Pediatr Diabetes. 2016 Feb;17(1):28-35. doi: 10.1111/pedi.12230. Epub 2014 Oct 27.
PubMed 25348683
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents
- ClinicalTrials.gov ID
- NCT01890954
- Acronym / sponsor ID
- 16890
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Closed Loop Control (CLC), Diabetes Assistant (DiAs), Continuous Glucose Monitor (CGM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Posted 15 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's ability to significantly improve blood glucose levels when an insulin bolus is omitted for a 30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of carbohydrates consumed for a meal. The primary objective of this study is to use a closed-loop Control-to-Range (CTR) system to significantly reduce the post-prandial blood glucose excursion in adolescents with type 1 diabetes who omit and/or under-bolus insulin for either snacks or meals. Up to 20 subjects aged ≥13 and ≤18 years old will be tested.
Detailed description
The purpose of this study is to use a closed-loop Control-to-Range (CTR) system in adolescents with type 1 diabetes in an outpatient setting, and to evaluate the CTR system's ability to significantly improve blood glucose levels when an insulin bolus is omitted for a 30 gram carbohydrate snack and when insulin bolus is insufficient for the amount of carbohydrates consumed for a meal. The CTR system is comprised of two algorithmic layers: (i) A Safety Supervision Module (SSM) which contains a predictive insulin request dampener (or brakes); (ii) a Range Correction Module (RCM), consisting in (a) a Hyperglycemia Mitigation System, and (b) Insulin on Board controller. Both modules will receive continuous glucose monitoring (CGM) and historical insulin delivery data. The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia. The RCM will be responsible for optimizing blood glucose (BG) control and mitigating postprandial hyperglycemic excursions through a mix of increased basal rate and, potentially, isolated insulin boluses. To run CTR, we will use our wearable artificial pancreas platform, known as DiAs (Diabetes Assistant) which consists of a smart phone running CTR and connected to standard insulin delivery and CGM devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DiAs-closed-loop system | Active comparator | Device: Diabetes Assistant (DiAs)eight hours using Closed Loop Control (DiAs) under both, miss insulin bolus for 30 grams of carbohydrates snack or under bolus for an 80 grams of carbohydrates lunch |
| Sensor Augmented Pump | No intervention | –8 hours observational under both, missed insulin bolus for 30 gr carbohydrates snack and under bolus for an 80 gr carbohydrates lunch. Sensor augmented pump used the patients own insulin settings (basal rate, meal boluses and correction boluses) and a CGM provided by the study team to be used during admission. No DiAs use during this admission. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (24 listed)
- ≥13 and ≤18 years old
- Clinical diagnosis of type 1 diabetes mellitus for at least 2 years as noted by the following:
- Use of an insulin pump to treat his/her diabetes for at least 6 months
- Actively using a carbohydrate (CHO) /insulin ratio for insulin bolus adjustments in order to keep blood glucose in a predefined range
- Tanner stage II or greater based on physician exam
Key exclusion criteria (31 listed)
- Diabetic ketoacidosis (DKA) within the 6 months prior to enrollment
- In adherence with the One Touch Ultra 2 User Guide, subjects with hematocrit levels below 30% or above 55% will be excluded. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy; breast feeding, or intention of becoming pregnant
- Uncontrolled arterial hypertension (based on resting blood pressure > 95 percentile as listed according to age and height percentile in the Harriet Lane Handbook of Pediatrics)
- Conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented electrocardiogram (EKG) changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation
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)Also: Closed-Loop systemDiabetes Assistance (DiAs) is a software residing in a Smartphone that contains the algorithms to regulate and control insulin deliveries (insulin bolus for: Basal rate, meal insulin and correction bolus) with inputs glucose values from a CGM and outputs insulin infusion by an insulin pump | Device | DiAs-closed-loop system |
Primary outcome
Percent of Time Spent Near Normoglycemia
Time frame: 8 hours
Percentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25348683Chernavvsky DR, DeBoer MD, Keith-Hynes P, Mize B, McElwee M, Demartini S, Dunsmore SF, Wakeman C, Kovatchev BP, Breton MD. Use of an artificial pancreas among adolescents for a missed snack bolus and an underestimated meal bolus. Pediatr Diabetes. 2016 Feb;17(1):28-35. doi: 10.1111/pedi.12230. Epub 2014 Oct 27.
- Individual participant dataSharing planned: Yes. We will make de-identified individual participant data (IPD) collected in this study available to other researchers at the end of the study. Paper published in Pediatric Diabetes
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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.
Daniel R. Chernavvsky, MD, CRC principal investigator
University of Virginia
Mark DeBoer, 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 Diabetes Assistant (DiAs) 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 24 inclusion and 31 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 13 Sep 2022. 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 15 Apr 2015). 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 Time Spent Near Normoglycemia (time frame: 8 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 NCT01890954, 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 13 Sep 2022.