Type1 Diabetes MellitusDSSNCT03093636
Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes
A study testing Continuous Glucose Monitor (CGM)+Decision Support System (DSS) and Continuous Glucose Monitor (CGM) alone in people with Type1 Diabetes Mellitus, run by University of Virginia at 3 sites in United States.
Trial summary
The purpose of this study is to reduce the frequency of hypoglycemia and severe hypoglycemic events in subjects who use insulin pens to treat their Type 1 Diabetes Mellitus (T1DM). Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitor (CGM)+Decision Support System (DSS) and Continuous Glucose Monitor (CGM) alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Apr 2017to 19 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willingness to provide informed consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
- Using basal and meal insulin (NovoLog® [insulin aspart], Humalog® [insulin lispro] or Apidra® [insulin glulisine]) for Intensive Insulin Therapy including carbohydrate counting and use of pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor for at least 1 month.
- Acceptable basal insulin regimens include: i. Lantus® (insulin glargine) 100U/mL once or twice daily ii. Levemir® (insulin detemir) 100U/mL once or twice daily iii. Tresiba® (insulin degludec) 100U/mL once daily
- Age ≥15.0 years old
- Willingness to use the study basal insulin (Tresiba® [insulin degludec]) and meal insulin (NovoLog® [insulin aspart]) for the duration of the study.
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- Willingness to use the home or DSS-optimized carbohydrate counting parameters for all meal dosing and enter the information into the inControl APP (for CGM+DSS group).
- For females, not currently known to be pregnant
- If female and sexually active, must agree to use a highly effective form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Ability to access the Internet to provide data to the clinical team or to travel to the research center so that the study equipment can be downloaded.
- Ability to have 3G or Wi-Fi to be able to use the DSS smart bolus calculator and advice given (i.e. sleep, exercise).
- Demonstration of proper mental status and cognition for the study
- Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
- If on a non-insulin hyperglycemic therapy, stability on that therapy for the prior 3 months and willingness not to alter the therapy for the study duration.
Who cannot join
- Medical need for chronic acetaminophen
- Use of any medication that at the discretion of the clinical protocol chair is deemed to interfere with the trial.
- Current treatment of a seizure disorder.
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
- Hemophilia or any other bleeding disorder
- A known medical condition, which in the opinion of the investigator or designee, would put the participant or study at risk such as the following examples:
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- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- Abnormal liver function test results (Transaminase >3 times the upper limit of normal)
- Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2).
- Active gastroparesis requiring medical therapy
- Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L).
- Abuse of alcohol or recreational drugs
- 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).
- Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) 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.
- 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 l. Oral steroids m. Any other medication that the investigator believes is a contraindication to the subject's participation
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22903
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Stanford University
Stanford, California, 94304
About this study
The purpose of this study is to reduce the frequency of hypoglycemia and severe hypoglycemic events in subjects who use insulin pens to treat their Type 1 Diabetes Mellitus (T1DM). Hypoglycemia is the number one fear of many individuals and families with someone who has type 1 diabetes, and this fear often prevents optimal glycemic control. It is expected that this protocol will yield increased knowledge about using a decision support system to help control the glucose level.
Read the detailed description
This study is a 12-week parallel group multi-center randomized trial designed to compare CGM+DSS with CGM alone. The DSS to be implemented contains a "smart" bolus advisor that adjusts the size of correction insulin boluses based on short term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c.
inControl-Advice, a smart-phone based medical software platform, is designed to provide advice to users. It receives data from an insulin pen and then adjustments the insulin delivery every 5 minutes. The system provides a series of real-time alerts and on-demand advice, for both dosing of insulin and ingestion of carbohydrates, based on data collected from T1DM patients (i.e. carbohydrate consumption, insulin injected, CGM) and inConrol Cloud analytics.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Continuous Glucose Monitor (CGM)+Decision Support System (DSS), Continuous Glucose Monitor (CGM) alone
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI), Insulin Pen, inControl Advice, Decision Support System (DSS)
- 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.
Continuous Glucose Monitor (CGM)+Decision Support System (DSS)Device
Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App and a study CGM at home for 12 weeks. The DSS contains a "smart" bolus advisor that adjusts the size of the correction insulin boluses based on short-term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. Subjects will use study basal and bolus insulin during the study.
Continuous Glucose Monitor (CGM) aloneOther
Continuous Glucose Monitor (CGM) alone study participants will use a study CGM at home for 12 weeks. Subjects will use study basal and bolus insulin during the study.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor (CGM)+Decision Support System (DSS) | Experimental | Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App, study insulin, and study CGM at home for 12 weeks. Receives: Device: Continuous Glucose Monitor (CGM)+Decision Support System (DSS) |
| Continuous Glucose Monitor (CGM) alone | Placebo comparator | Continuous Glucose Monitor (CGM) alone study participants will use study insulin and the study CGM alone at home for 12 weeks. Receives: Other: Continuous Glucose Monitor (CGM) alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Time Within Target Range
The primary efficacy outcome is increased % time within target range defined as CGM readings of 70-180 mg/dL.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start17 Apr 2017
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- TypeZero Technologies, Novo Nordisk A/S, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Stacey M. Anderson, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093636
- Sponsor's protocol ID
- 19634
- Other IDs
- DP3DK101055, U1111-1191-3911
- Acronym
- DSS
- Status last verified
- Nov 2022
- First submitted
- 22 Mar 2017
- Last updated
- 18 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: pending
Publications
Bisio A, Anderson S, Norlander L, O'Malley G, Robic J, Ogyaadu S, Hsu L, Levister C, Ekhlaspour L, Lam DW, Levy C, Buckingham B, Breton MD. Impact of a Novel Diabetes Support System on a Cohort of Individuals With Type 1 Diabetes Treated With Multiple Daily Injections: A Multicenter Randomized Study. Diabetes Care. 2022 Jan 1;45(1):186-193. doi: 10.2337/dc21-0838.
PubMed 34794973
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes
- ClinicalTrials.gov ID
- NCT03093636
- Acronym / sponsor ID
- DSS / 19634
- Conditions
- Type1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus (T1DM), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI), Insulin Pen, inControl Advice, Decision Support System (DSS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- TypeZero Technologies, Novo Nordisk A/S, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Posted 18 Nov 2022
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 reduce the frequency of hypoglycemia and severe hypoglycemic events in subjects who use insulin pens to treat their Type 1 Diabetes Mellitus (T1DM). Hypoglycemia is the number one fear of many individuals and families with someone who has type 1 diabetes, and this fear often prevents optimal glycemic control. It is expected that this protocol will yield increased knowledge about using a decision support system to help control the glucose level.
Detailed description
This study is a 12-week parallel group multi-center randomized trial designed to compare CGM+DSS with CGM alone. The DSS to be implemented contains a "smart" bolus advisor that adjusts the size of correction insulin boluses based on short term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c.
inControl-Advice, a smart-phone based medical software platform, is designed to provide advice to users. It receives data from an insulin pen and then adjustments the insulin delivery every 5 minutes. The system provides a series of real-time alerts and on-demand advice, for both dosing of insulin and ingestion of carbohydrates, based on data collected from T1DM patients (i.e. carbohydrate consumption, insulin injected, CGM) and inConrol Cloud analytics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor (CGM)+Decision Support System (DSS) | Experimental | Device: Continuous Glucose Monitor (CGM)+Decision Support System (DSS)Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App, study insulin, and study CGM at home for 12 weeks. |
| Continuous Glucose Monitor (CGM) alone | Placebo comparator | Other: Continuous Glucose Monitor (CGM) aloneContinuous Glucose Monitor (CGM) alone study participants will use study insulin and the study CGM alone at home for 12 weeks. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Willingness to provide informed consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
- Using basal and meal insulin (NovoLog® [insulin aspart], Humalog® [insulin lispro] or Apidra® [insulin glulisine]) for Intensive Insulin Therapy including carbohydrate counting and use of pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor for at least 1 month.
- Age ≥15.0 years old
- Willingness to use the study basal insulin (Tresiba® [insulin degludec]) and meal insulin (NovoLog® [insulin aspart]) for the duration of the study.
Key exclusion criteria (20 listed)
- Medical need for chronic acetaminophen
- Use of any medication that at the discretion of the clinical protocol chair is deemed to interfere with the trial.
- Current treatment of a seizure disorder.
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
- Hemophilia or any other bleeding disorder
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 |
|---|---|---|
| Continuous Glucose Monitor (CGM)+Decision Support System (DSS)Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App and a study CGM at home for 12 weeks. The DSS contains a "smart" bolus advisor that adjusts the size of the correction insulin boluses based on short-term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. Subjects will use study basal and bolus insulin during the study. | Device | Continuous Glucose Monitor (CGM)+Decision Support System (DSS) |
| Continuous Glucose Monitor (CGM) aloneContinuous Glucose Monitor (CGM) alone study participants will use a study CGM at home for 12 weeks. Subjects will use study basal and bolus insulin during the study. | Other | Continuous Glucose Monitor (CGM) alone |
Primary outcome
% Time Within Target Range
Time frame: 12 weeks
The primary efficacy outcome is increased % time within target range defined as CGM readings of 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 18 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34794973Bisio A, Anderson S, Norlander L, O'Malley G, Robic J, Ogyaadu S, Hsu L, Levister C, Ekhlaspour L, Lam DW, Levy C, Buckingham B, Breton MD. Impact of a Novel Diabetes Support System on a Cohort of Individuals With Type 1 Diabetes Treated With Multiple Daily Injections: A Multicenter Randomized Study. Diabetes Care. 2022 Jan 1;45(1):186-193. doi: 10.2337/dc21-0838.
- Individual participant dataSharing planned: Yes. pending
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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.
Stacey M. Anderson, MD principal investigator
University of Virginia Center for Diabetes Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor (CGM)+Decision Support System (DSS) and Continuous Glucose Monitor (CGM) alone in people with Type1 Diabetes Mellitus, run by University of Virginia at 3 sites 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 14 inclusion and 20 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 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 18 Nov 2022). 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?
% Time Within Target Range (time frame: 12 weeks). 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 NCT03093636, 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 18 Nov 2022.