NCT02424500

Brief Summary

Hygieia Research seeks to conduct a prospective randomized clinical study involving adult subjects with uncontrolled Type-2 diabetes requiring insulin. The study seeks to demonstrate that the clinical application of the d-Nav will achieve metabolic control in a safe and effective manner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

April 9, 2015

Last Update Submit

February 25, 2019

Conditions

Diabetes Mellitus, Type 2Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Reduction in HbA1C

    To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.

    6 months

Secondary Outcomes (4)

  • Comparison Percent Reduction HbA1c

    6 months

  • Number of Glucose Readings <70 mg/dl

    3 and 6 months

  • Change in Rate of Hypoglycemia

    6 months

  • Comparison Percent Reduction HbA1c w/out Hypoglycemia

    6 months

Study Arms (2)

d-Nav Device

EXPERIMENTAL

d-Nav Device: daily use to provide insulin dosage updates weekly - or sooner when needed based on analyzes and evaluates the historical blood glucose patterns. Insulin dosage is adjusted as required

Device: d-Nav

Blood Glucose Monitoring System

ACTIVE COMPARATOR

Patient's personal Over the Counter Blood Glucose Monitoring System (OTC BGMS) for daily glucose testing to determine insulin dosage needed. Insulin dosage is adjusted as required

Device: Blood Glucose Monitoring System

Interventions

d-NavDEVICE

Insulin dosage is adjusted as required

d-Nav Device
Blood Glucose Monitoring SystemDEVICE

Insulin dosage is adjusted as required

Blood Glucose Monitoring System

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years of age
  • If female, must be of non-childbearing potential or have a negative urine pregnancy test at screening and using adequate method of contraception throughout conduct of the study
  • Clinical diagnosis of Type-2 diabetes for at least 1-year
  • HbA1c 7.5% to 11% inclusive
  • Total daily dose of insulin of 25 units or more (10 units if on Lantus® alone) using one of these insulin regimens:
  • Regimen 1 - a single injection of the long-acting insulin analog Lantus® (Glargine) per day (limited to a daily dose that is no more than 0.7 units per kg of body weight);
  • Regimen 2 - twice daily biphasic insulin (i.e., Humalog® Mix 75/25, NovoLog® Mix 70/30) or pre-mixed insulin (i.e., Humulin® 70/30, Novolin® 70/30);
  • Regimen 3 - a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and are treated with a single injection of the long-acting insulin analog Lantus® (Glargine) per day and do not utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses; or
  • Regimen 4 - with a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and a single injection of the long-acting insulin analog Lantus® (Glargine) per day and utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses.
  • On same insulin regimen for the previous 3-months
  • May be using other diabetes agents at a stable dose for the last 3-months
  • Signed and dated informed consent document, which contains HIPAA waiver information informing about all of the aspects of the clinical study;
  • Will regularly conduct Self-Monitored Blood Glucose. Prior to randomization must meet the following .
  • Minimum number of tests required from all subjects:
  • Basal insulin subjects at least 4 fasting glucose readings/wk
  • +8 more criteria

You may not qualify if:

  • History \>2 episodes of severe hypoglycemia (see definition below) in the past year, or hypoglycemic unawareness when glucose levels are ≤ 50 mg/dl;
  • Significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol at the discretion of the PI;
  • Splitting Lantus and taking Lantus twice a day
  • Severe cardiovascular disease including a history of congestive heart failure, unstable angina, myocardial infarction or stroke within the 6-months preceding enrollment;
  • Active anemia w/ hematocrit ≤ 25% in women or 30% in men;
  • Advanced kidney disease Stage 4 (eGFR \< 30 ml/min) and above
  • Active cancer or cancer in the past 2-years (except non-melanoma skin cancer)
  • History of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values).
  • BMI \> 45 kg/m2
  • Are pregnant, plan to become pregnant during the study period, or are breastfeeding.
  • Have a BGMS that cannot be downloaded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park Nicollet Institute / International Diabetes Center, Minneapolis, MN

Minneapolis, Minnesota, 55416-2699, United States

Location

Related Publications (1)

  • Bergenstal RM, Johnson M, Passi R, Bhargava A, Young N, Kruger DF, Bashan E, Bisgaier SG, Isaman DJM, Hodish I. Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial. Lancet. 2019 Mar 16;393(10176):1138-1148. doi: 10.1016/S0140-6736(19)30368-X. Epub 2019 Feb 23.

    PMID: 30808512DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Richard M Bergenstal, MD

    Executive Director International Diabetes Center

    PRINCIPAL INVESTIGATOR

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

April 9, 2015

First Posted

April 23, 2015

Study Start

January 1, 2015

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

US(1)