Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes

NCT03093636 | Completed Results FDA Device

• 3 other identifiers: 19634DP3DK101055U1111-1191-3911
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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). 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.

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)

Outcome Measures

Primary Outcomes (1)

• % Time Within Target Range

  The primary efficacy outcome is increased % time within target range defined as CGM readings of 70-180 mg/dL.

  12 weeks

Study Arms (2)

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.

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.

Other: Continuous Glucose Monitor (CGM) alone

Interventions

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)+Decision Support System (DSS)

Continuous Glucose Monitor (CGM) alone OTHER

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.

Continuous Glucose Monitor (CGM) alone

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• a. 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.
• 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.

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• University of Virginia: lead
• TypeZero Technologies: collaborator
• Novo Nordisk A/S: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• DexCom, Inc.: collaborator

Study Sites (3)

Stanford University

Stanford, California, 94304, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 34794973 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring; Single Person

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Limitations and Caveats

Target enrollment was not reached. Experienced larger-than-expected attrition and, therefore, did not achieve the originally intended statistical power.

Results Point of Contact

• Title: Marc Breton, PhD
• Organization: University of Virginia Center for Diabetes Technology

MB6NT@uvahealth.org

(434) 982-6484

Study Officials

• Stacey M. Anderson, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: April 17, 2017
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: November 18, 2022
• Results First Posted: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (3)