Diabetes Mellitus, Type 2NCT02424500
Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy
A study testing d-Nav and Blood Glucose Monitoring System in people with Diabetes Mellitus, Type 2 and Hypoglycemia, run by Hygieia Research LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypoglycemia
- What is being tested?
- d-Nav and Blood Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 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);
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- 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
- Premixed insulin subjects at least 8 readings/wk
- Basal-bolus insulin therapy subjects at least 16 total readings/wk
- Willing and able to comply with the scheduled clinical study activities and glucose testing:
- Basal insulin subjects at least 5 fasting glucose readings/wk
- Premixed insulin subjects at least 5 pre-breakfast and 5 pre-evening meal readings/wk
- Basal-bolus insulin therapy subjects at least 20 total readings/wk which include 5 readings before each of the following time points: breakfast, lunch, evening meal and bedtime.
- Note: All subjects may be asked to test during the night if clinically indicated.
- Participant must have a primary care provider
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Institute / International Diabetes Center, Minneapolis, MN
Minneapolis, Minnesota, 55416-2699
About this study
Official title: Prospective, Open-Label, Randomized, Controlled, Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device
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.
Read the detailed description
The purpose of this study is to demonstrate that the use of d-Nav (d-Nav group) is superior to titration of insulin dosage relying on data from glucose meters with health care provider support (Control) in the management of insulin treated diabetes, by randomizing 200 insulin treated subjects with type 2 diabetes.
Primary Objective: To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Being tested
- d-Nav, Blood Glucose Monitoring System
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-NavDevice
Insulin dosage is adjusted as required
Blood Glucose Monitoring SystemDevice
Insulin dosage is adjusted as required
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Blood Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Comparison Percent Reduction HbA1c
To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c < 7.0%, < 8.0%, and >9.0% at 6 months
Measured: 6 months
Number of Glucose Readings <70 mg/dl
To determine the difference between the Control and d-Nav group in the number of glucose readings <70 mg/dl (symptomatic or asymptomatic) utilizing the documented downloaded glucose values.
Measured: 3 and 6 months
Change in Rate of Hypoglycemia
To determine change (if any) in rate of hypoglycemia, during the study for d-Nav users in the secondary cohort
Measured: 6 months
Comparison Percent Reduction HbA1c w/out Hypoglycemia
To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c < 7.0%, < 8.0% without a severe hypoglycemia event at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJan 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hygieia Research LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard M Bergenstal, MD, Principal investigator, Executive Director International Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424500
- Sponsor's protocol ID
- PD004-1
- Other IDs
- 5R42DK085974-03
- Status last verified
- Feb 2019
- First submitted
- 9 Apr 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30808512
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Randomized, Controlled, Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device
- ClinicalTrials.gov ID
- NCT02424500
- Acronym / sponsor ID
- PD004-1
- Conditions
- Diabetes Mellitus, Type 2, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Hygieia Research LLCUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2015
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to demonstrate that the use of d-Nav (d-Nav group) is superior to titration of insulin dosage relying on data from glucose meters with health care provider support (Control) in the management of insulin treated diabetes, by randomizing 200 insulin treated subjects with type 2 diabetes.
Primary Objective: To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| d-Nav Device | Experimental | Device: d-Navd-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 |
| Blood Glucose Monitoring System | Active comparator | Device: Blood Glucose Monitoring SystemPatient'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 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 21 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:
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| d-NavInsulin dosage is adjusted as required | Device | d-Nav Device |
| Blood Glucose Monitoring SystemInsulin dosage is adjusted as required | Device | Blood Glucose Monitoring System |
Primary outcome
Reduction in HbA1C
Time frame: 6 months
To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
4 secondary outcomes
Comparison Percent Reduction HbA1c
Time frame: 6 months
Number of Glucose Readings <70 mg/dl
Time frame: 3 and 6 months
Change in Rate of Hypoglycemia
Time frame: 6 months
Comparison Percent Reduction HbA1c w/out Hypoglycemia
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 30808512Bergenstal 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.
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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.
Richard M Bergenstal, MD principal investigator
Executive Director International Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing d-Nav and Blood Glucose Monitoring System in people with Diabetes Mellitus, Type 2 and Hypoglycemia, run by Hygieia Research LLC at 1 site 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 23 inclusion and 11 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in HbA1C (time frame: 6 months). 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 NCT02424500, 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 27 Feb 2019.