Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM

NCT02558491 | Completed Results

• 3 other identifiers: 183485R01DK051562-18G150172
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

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; Multiple Daily Injections (MDI)

Outcome Measures

Primary Outcomes (1)

• Glucose Variability (Coefficient of Variation)

  Assess effectiveness of glucose variability (GV) advisory system in reducing glucose variability in T1DM patient using an insulin pump.

  Duration of the 48 hour study admission

Secondary Outcomes (12)

• Low Blood Glucose Index (LBGI)

  48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am).

• Percent Below 50 mg/dL

  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

  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

  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

  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).

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Decision Support System DEVICE

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: 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.

Decision Support System

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A. Historical criteria for documented hyperglycemia (at least 1 must be met):
• i. 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.
• B. Historical criteria for requiring insulin at diagnosis (1 must be met):
• i. 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.
• iii. 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.
• 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.

You may not qualify if:

• 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:
• i. 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).
• x. Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg).
• xi. 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.

Sponsors & Collaborators

• Daniel Chernavvsky, MD: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• 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.

  PMID: 29979618 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Daniel R. Chernavvsky, MD
• Organization: University of Virginia Center for Diabetes Technology

mc7m@virginia.edu

434-982-0602

Study Officials

• Daniel Cherñavvsky, MD, CRC

  UVA Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 24, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 7, 2024
• Results First Posted: March 23, 2023

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)