Type 1 Diabetes MellitusNCT02558491
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
A study testing Decision Support System in people with Type 1 Diabetes Mellitus, run by Daniel Chernavvsky, MD at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Decision Support System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Feb 2017
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis based on investigator assessment, of type 1 diabetes for at least one year and either using insulin pump therapy for at least 6 months or MDI therapy (consisting of a of Lantus [glargine], Tresiba [degludec], or Levemir [Detemir] plus rapid-acting meal insulin) for at least 6 months; 1-2 basal insulin injections per day, consistent in timing and amount.
- Historical criteria for documented hyperglycemia (at least 1 must be met):
- Fasting glucose ≥126 mg/dL. ii. Two-hour oral glucose tolerance test (OGTT) glucose ≥200 mg/dL. iii. Hemoglobin A1c ≥6.5% documented. iv. Random glucose ≥200 mg/dL with symptoms. v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes.
- Historical criteria for requiring insulin at diagnosis (1 must be met):
- Participant required insulin at diagnosis and continually thereafter. ii. 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.
Show all 38Show fewer
- Age 21- 65years old.
- Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
- Demonstration of proper mental status and cognition for the study
- MDI subjects should be administering the Lantus (glargine), Tresiba [degludec], or Levemir [Detemir] dose at approximately the same time each day.
- CSII subjects must currently be using the bolus calculator function of the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
- MDI users must currently be using Intensive Insulin Therapy including carbohydrate counting and use of pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
- Willing to use Humalog (lispro) or Novolog (aspart) insulin during the study procedures for MDI subjects.
- CSII subjects must be willing to use the current bolus calculator pump parameters and enter all carbohydrate intake into the pump during the 28 day data collection period.
- MDI users must be willing to use their carbohydrate counting parameters for all meal dosing and enter the information into the MySugr app.
- Ability to access the Internet to provide data to the clinical team or to travel to the research center so that the study equipment and personal pump can be downloaded.
- An understanding of and willingness to follow the protocol and sign the informed consent.
- Exclusion Criteria: The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
- Current treatment of a seizure disorder.
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
- Atrial or ventricular arrhythmias (benign premature atrial contractions [PACs] and premature ventricular contractions [PVCs] allowed)
- Cystic fibrosis.
- Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures.
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months ii. Presence of a known adrenal disorder iii. Abnormal liver function test results (Transaminase >2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function iv. Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty v. Active gastroparesis vi. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study vii. Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise viii. Abuse of alcohol or recreational drugs ix. Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >100 mmHg and/or systolic blood pressure >180 mmHg).
- Oral steroids xii. Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months.
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
- Basal Rates <0.01 units/hour for CSII subjects.
- More than one basal dose per day for MDI subjects
- Allergy for or intolerance of both Novolog (aspart) and Humalog (lispro) insulin for MDI subjects.
- Diagnosed food allergies.
- Current use of the following drugs and supplements:
- Regular acetaminophen user, or not willing to suspend acetaminophen 24 hours before and during the entire length of the trial ii. Any other medication that the investigator believes is a contraindication to the subject's participation
- Any reason for which the study MD considers the subject not properly fitted for the trial (i.e. insulin pump that does not record what is needed for the trial).
- Current enrollment in another clinical trial.
Who cannot join
None listed.
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 demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump.
Read the detailed description
The overall aim of this proposed research is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump. The system will be deployed on our portable medical application platform (DiAs) and will include insulin pump treatment parameters optimization and an exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
A second phase of the trial will enroll additional users of insulin pumps, and subjects who treat their T1DM with the use of multiple daily injections (MDI) of insulin. MDI users should be administering the Lantus (glargine) dose at approximately the same time each day and use only one basal rate per day. MDI users will also use MySugr app to count carbohydrates for all meals that require insulin treatment.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Decision Support System, Usual Care
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Insulin Pump, Continuous Glucose Monitor, Exercise, Glucose Variability, Decision Support System, Multiple Daily Injections (MDI)
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support SystemDevice
The purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing glucose variability in T1DM patient using an insulin pump or MDI. The system will be deployed on our portable medical application platform (DiAs) and will include the following elements:
- An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
- An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
- A smart bolus calculator based on CGM glucose measurements and insulin sensitivity estimation.
Usual CareOther
During the Control study admission, DiAs will be programmed with the home insulin dosing parameters. The study subject will use the home basal/bolus MDI or continuous subcutaneous insulin infusion (CSII) insulin regimen via the home insulin pens or pump and determine the amount of insulin to give for the entire admission per the subject's home carb counting parameters and as calculated by the DiAs meal screen.
| Study group | Role | What they receive |
|---|---|---|
| Decision Support System | Experimental | Blinded continuous glucose monitor (CGM) data will be collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters for each insulin pump and multiple daily injections (MDI) participant. These optimized parameters will be used during the Experimental Admission. Receives: Device: Decision Support System |
| Usual Care | Active comparator | Insulin pump and MDI participants will use their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Variability (Coefficient of Variation)
Assess effectiveness of glucose variability (GV) advisory system in reducing glucose variability in T1DM patient using an insulin pump.
Measured: Duration of the 48 hour study admission
Secondary outcomes (12)
Low Blood Glucose Index (LBGI)
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM (Insulin dependent diabetes mellitus): validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am).
Percent Below 50 mg/dL
CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Below 60 mg/dL
CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Below 70 mg/dL
CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Between 70 and 180 mg/dL
CGM measured blood sugar values between 70 abd 180 mg/dL are considered to be desirable. A higher percentage of time in this range is indicative of a desirable outcome.
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Above 180 mg/dL
CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Above 250 mg/dL
CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Above 300 mg/dL
CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Average Glycemia (mg/dL)
Average glycemia is a measure of the average CGM value in mg/dL during the 48 hour study admission. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Total Insulin Used
This measure is an average of the total amount of insulin (both basal and bolus) used by participants during the study admission.
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Basal Insulin Used
This measure is an average of the total amount of basal insulin used by participants during the study admission.
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Total Rescue Carbohydrates (CHO) (Grams)
The average of the total amount of rescue carbohydrates (grams) administered during the study admission under safety protocols. Administering fewer carbohydrates is a desirable outcome because it indicates better control.
Measured: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2017
- Study completionFeb 2017
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 Type 1 Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Chernavvsky, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Chernavvsky, MD, University of Virginia
- Investigators
- Daniel Cherñavvsky, MD, CRC, Principal investigator, UVA Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558491
- Sponsor's protocol ID
- 18348
- Other IDs
- 5R01DK051562-18, G150172
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2015
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: To be determined
Publications
Breton MD, Patek SD, Lv D, Schertz E, Robic J, Pinnata J, Kollar L, Barnett C, Wakeman C, Oliveri M, Fabris C, Chernavvsky D, Kovatchev BP, Anderson SM. Continuous Glucose Monitoring and Insulin Informed Advisory System with Automated Titration and Dosing of Insulin Reduces Glucose Variability in Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2018 Aug;20(8):531-540. doi: 10.1089/dia.2018.0079. Epub 2018 Jul 6.
PubMed 29979618
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
- ClinicalTrials.gov ID
- NCT02558491
- Acronym / sponsor ID
- 18348
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Insulin Pump, Continuous Glucose Monitor, Exercise, Glucose Variability, Decision Support System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Daniel Chernavvsky, MDUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Posted 23 Mar 2023
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 demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump.
Detailed description
The overall aim of this proposed research is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump. The system will be deployed on our portable medical application platform (DiAs) and will include insulin pump treatment parameters optimization and an exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.
A second phase of the trial will enroll additional users of insulin pumps, and subjects who treat their T1DM with the use of multiple daily injections (MDI) of insulin. MDI users should be administering the Lantus (glargine) dose at approximately the same time each day and use only one basal rate per day. MDI users will also use MySugr app to count carbohydrates for all meals that require insulin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Support System | Experimental | Device: Decision Support SystemBlinded continuous glucose monitor (CGM) data will be collected prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters for each insulin pump and multiple daily injections (MDI) participant. These optimized parameters will be used during the Experimental Admission. |
| Usual Care | Active comparator | Other: Usual CareInsulin pump and MDI participants will use their own insulin parameters, including basal rate, correction factor and carbohydrate-insulin ratio, and determine their own insulin usage during the Control Admission. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Clinical diagnosis based on investigator assessment, of type 1 diabetes for at least one year and either using insulin pump therapy for at least 6 months or MDI therapy (consisting of a of Lantus [glargine], Tresiba [degludec], or Levemir [Detemir] plus rapid-acting meal insulin) for at least 6 months; 1-2 basal insulin injections per day, consistent in timing and amount.
- Age 21- 65years old.
- Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
- Demonstration of proper mental status and cognition for the study
- MDI subjects should be administering the Lantus (glargine), Tresiba [degludec], or Levemir [Detemir] dose at approximately the same time each day.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Decision Support SystemThe purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing glucose variability in T1DM patient using an insulin pump or MDI. The system will be deployed on our portable medical application platform (DiAs) and will include the following elements: 1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data 2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment. 3. A smart bolus calculator based on CGM glucose measurements and insulin sensitivity estimation. | Device | Decision Support System |
| Usual CareDuring the Control study admission, DiAs will be programmed with the home insulin dosing parameters. The study subject will use the home basal/bolus MDI or continuous subcutaneous insulin infusion (CSII) insulin regimen via the home insulin pens or pump and determine the amount of insulin to give for the entire admission per the subject's home carb counting parameters and as calculated by the DiAs meal screen. | Other | Usual Care |
Primary outcome
Glucose Variability (Coefficient of Variation)
Time frame: Duration of the 48 hour study admission
Assess effectiveness of glucose variability (GV) advisory system in reducing glucose variability in T1DM patient using an insulin pump.
12 secondary outcomes
Low Blood Glucose Index (LBGI)
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am).
Percent Below 50 mg/dL
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Below 60 mg/dL
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Below 70 mg/dL
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Between 70 and 180 mg/dL
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Above 180 mg/dL
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Above 250 mg/dL
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Percent Above 300 mg/dL
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Average Glycemia (mg/dL)
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Total Insulin Used
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Basal Insulin Used
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Total Rescue Carbohydrates (CHO) (Grams)
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29979618Breton MD, Patek SD, Lv D, Schertz E, Robic J, Pinnata J, Kollar L, Barnett C, Wakeman C, Oliveri M, Fabris C, Chernavvsky D, Kovatchev BP, Anderson SM. Continuous Glucose Monitoring and Insulin Informed Advisory System with Automated Titration and Dosing of Insulin Reduces Glucose Variability in Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2018 Aug;20(8):531-540. doi: 10.1089/dia.2018.0079. Epub 2018 Jul 6.
- Individual participant dataSharing planned: Yes. To be 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.
Daniel Cherñavvsky, MD, CRC principal investigator
UVA 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 Decision Support System in people with Type 1 Diabetes Mellitus, run by Daniel Chernavvsky, MD 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 38 inclusion and 0 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 7 Aug 2024. 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 Mar 2023). 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?
Glucose Variability (Coefficient of Variation) (time frame: Duration of the 48 hour study admission). 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 NCT02558491, 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 7 Aug 2024.