Optimizing Closed-Loop Control of Type 1 Diabetes Mellitus in Adolescents

NCT01890954 | Completed Results

• 1 other identifier: 16890
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes Mellitus (T1DM); Closed Loop Control (CLC); Diabetes Assistant (DiAs); Continuous Glucose Monitor (CGM)

Outcome Measures

Primary Outcomes (1)

• 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).

  8 hours

Study Arms (2)

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

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.

Interventions

Diabetes Assistant (DiAs) DEVICE

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

Also known as: Closed-Loop system

DiAs-closed-loop system

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≥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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• 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.

  PMID: 25348683 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

BG values followed 4 h after the unannounced meals, risk for hypoglycemia could have been detected if followed longer

Results Point of Contact

• Title: Daniel Chernavvsky
• Organization: University of Virginia

drc2v@virginia.edu

434-243-1395

Study Officials

• Daniel R. Chernavvsky, MD, CRC

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Mark DeBoer, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 13, 2022
• Results First Posted: April 15, 2015

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)