Type 2 Diabetes MellitusINNOVATENCT02540486

Long Acting Insulin Glargine Titration Web Tool (LTHome) vs Enhanced Usual Therapy of Glargine Titration

A study testing Long-acting insulin glargine titration web tool (LTHome) and Diabetes Education in people with Type 2 Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Evaluating patients with type 2 diabetes either starting once daily basal insulin or requiring increased basal titrations in order to compare the LTHome web based tool with the usual standard of practice for insulin glargine dosing adjustment. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Long-acting insulin glargine titration web tool (LTHome) and Diabetes Education
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 1 siteCanada
Study dates: Dec 2013to Mar 2015
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient with type 2 diabetes mellitus (T2DM) between 18 and 75 years old (inclusively) with BMI ≤ 45 kg/m2.
Signed written informed consent
Patients scheduled to: initiate basal insulin treatment or increase their dose of current basal insulin therapy, independently of study participation, because of :
inadequate blood glucose control
If on basal therapy at screening, must be using a stable dose of insulin glargine x 1 week prior to randomization
Patients with poor blood glucose control defined by:

Show all 10Show fewer

HbA1c level between > 7% at screening AND
mean FPG > 7 mmol/l as determined by most recent self-measured blood glucose in 3 of 7 days prior to randomization
Patients proficient in computer literacy
Patient is able and willing to monitor glucose with a home glucose monitor, and consistently record his/her blood glucose and insulin doses in a patient diary/web tool.

Who cannot join

Any technical/administrative reason that makes it impossible to include the patient in the study, including closing enrollment due to full enrollment
Patient who has previously participated in any clinical trial investigating the LTHome algorithm
Patient who withdraws consent during screening (starting from signed informed consent form)
Use of systemic steroids in the last 90 days
Conditions/situations:
Patients with short life expectancy (less than 1 year)

Show all 17Show fewer

Type 1 diabetes mellitus
Patients with conditions/concomitant diseases making them non-evaluable for the primary efficacy endpoint
Clinically significant cardiac disease, retinopathy, hepatic, renal dysfunction or relevant other major diseases as determined by Principal Investigator or designee.
Unstable oral antihyperglycemic drugs and/or Glucagon-Like Peptide Receptor (GLP-1R) Agonists therapy during the 4 week period prior to screening
Impossibility to meet specific protocol requirements (e.g. ability to perform blood glucose measurements, manage their own insulin glargine administration or deemed unlikely to safely manage insulin dosage on guidance by their HCP)
Patient is a primary relative of the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, or other staff or is directly involved in the conduct of the protocol
Patients with hypoglycemia unawareness, severe hypoglycemic episode in the last 90 days or hospitalization (for any reason) in the last 30 days
Cognitive disorder, dementia or any neurologic disorder, that would affect patient's ability to participate in the study, or patients who have no legal capacity or are under guardianship
Pregnant or breastfeeding women, or women of child-bearing potential not protected by highly effective method(s) of birth control (as defined in the informed consent form and/or in a local protocol addendum) and who are unwilling or unable to be tested for pregnancy.
Patients who are using, or need to start using, mealtime (Bolus) insulin during the timeframe of the study.
Night shift workers

Trial locations and contacts

1 site in 1 country.

Canada1 site

LMC Diabetes & Endocrinology
Toronto, Ontario, M4G 3E8

Other trials in Canada

About this study

Official title: A 12 Week, Parallel, Open-label, Randomized, Multi-center Study Evaluating Use, Safety and Effectiveness of a Web Based Tool vs. Enhanced Usual Therapy of Glargine Titration in T2DM Patients With a 4 Week Safety Extension

Read the detailed description

INNOVATE is a 12 week, parallel, open-label, randomized, multi-center study evaluating use, safety and effectiveness of a web based tool (LTHome) vs. enhanced usual therapy (EUT) of glargine titration in T2DM patients.

The primary objective of this study is to compare the effectiveness LTHome versus EUT of glargine titration in people with T2DM patients on basal insulin not meeting local targets or patients requiring basal initiation. Success will be measured by the percentage of subjects reaching Canadian Diabetes Association (CDA) guideline targets.

The efficacy objective is to demonstrate that the percentage (%) of subjects to reach FPG target by titration of insulin glargine using the LTHome tool with dose adjustment advice is not inferior to the % of subjects to reach FPG target using Enhanced Usual Therapy glargine titration during study participation (LTHome vs. EUT treatments).

The secondary objectives of this study are to assess safety, effectiveness, satisfaction and adherence of LTHome use versus Enhanced Usual Therapy glargine titration.

Conditions: Type 2 Diabetes Mellitus
Being tested: Long-acting insulin glargine titration web tool (LTHome), Diabetes Education
Keywords: Type 2 diabetes, T2DM
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Long-acting insulin glargine titration web tool (LTHome)Other
The LTHome study arm will receive insulin glargine titration instructions from the LTHome web-based tool
Diabetes EducationOther
Individual diabetes education, detailed instructions on the use of the blood glucose monitor and unlimited availability of blood glucose monitoring supplies.

Study groups in NCT02540486
Study group	Role	What they receive
LTHome web tool	Experimental	The long-acting insulin glargine titration web tool (LTHome) will provide insulin glargine titration suggestions based on user inputted blood glucose readings. Receives: Other: Long-acting insulin glargine titration web tool (LTHome); Other: Diabetes Education
Enhanced Usual Therapy (EUT)	Active comparator	The Enhanced Usual Therapy arm will receive insulin glargine titration instructions that are the usual therapy provided by the physician/HCP, in addition to diabetes education. Receives: Other: Diabetes Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of subjects reaching fasting plasma glucose (FPG) target
The primary outcome is defined as all of the following
- At least 4 out of 7 FPG readings done within a 10 day period are within the target range of 5-7.2 mmol/L
- Mean glucose for three consecutive prior FPG values is between 5-7.2 mmol/L
- There is no severe hypoglycemia during the 7-10 day period (Severe hypoglycemia is defined as third party intervention in management of the hypoglycemia).
Measured: 12 weeks

Secondary outcomes (20)

Number of days to first reach fasting plasma glucose target
The number of days in the study until the first day the target is reached.
Measured: 12 weeks
Number of days in target range after reaching fasting plasma glucose target
The number of days after reaching target where the FPG was between 5.0 and 7.2 mmol/L (inclusive)
Measured: 12 weeks
Fasting plasma glucose
Fasting plasma glucose values over the entire study period will be summarized by mean and standard deviation
Measured: 12 weeks
Hemoglobin A1c (HbA1c)
The change in HbA1c will be evaluated as an expression of overall glycemic control in the two treatment arms and compared.
Measured: 12 weeks
Rate of documented hypoglycemia in subjects that reach target
Measured: 12 weeks
Rate of documented hypoglycemia in subjects that do not reach target
Measured: 12 weeks
Proportion of all patients with hypoglycemia
A summary of any hypoglycemia, severe hypoglycemia, nocturnal hypoglycemia, day-time hypoglycemia, symptomatic hypoglycemia, probable symptomatic hypoglycemia, and asymptomatic hypoglycemia will be summarized
Measured: 12 weeks
Frequency of contact with physician/HCP
The number of times subjects contacted their physician/HCP during the study
Measured: 12 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
A questionnaire to assess subject's overall satisfaction with their diabetes treatment
Measured: 12 weeks
Hypoglycemia Fear Survey (HFS)
A questionnaire to assess the subject's behaviours to avoid hypoglycemia and to measure the subjects' worries about hypoglycemia and its consequences
Measured: 12 weeks
WHO-5 Well-Being Index
A questionnaire to measure emotional well-being to screening for likely depression in subjects with diabetes
Measured: 12 weeks
Diabetes Distress Scale
A questionnaire to assess diabetes-related emotional distress
Measured: 12 weeks
LTHome Patient Satisfaction Survey
LTHome arm only; a questionnaire to measure satisfaction of the use of the LTHome
Measured: 12 weeks
Number of days subjects self-monitored their fasting plasma glucose
Measured: 12 weeks
Number of dose recommendations prior to reaching target - LTHome only
Measured: 12 weeks
Number of dose recommendations after target is reached - LTHome only
Measured: 12 weeks
Number of days insulin glargine was taken - LTHome only
Measured: 12 weeks
Reasons for disregarding LTHome advice - LTHome only
A summary of the reasons that subjects gave for not taking the insulin glargine dose recommendation given by the LTHome web tool when the recommendation was not followed
Measured: 12 weeks
Adverse events
Measured: 12 weeks
Serious adverse events
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Mar 2015

First posted4 Sep 2015 (estimated)
Study startDec 2013
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02540486
Sponsor's protocol ID: INNOVATE
Acronym: INNOVATE
Status last verified: Sep 2015
First submitted: 21 Aug 2015
Last updated: 4 Sep 2015
Results posted: No
Data monitoring committee: No

Publications

Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
PubMed 15855602
Strange P. Treat-to-target insulin titration algorithms when initiating long or intermediate acting insulin in type 2 diabetes. J Diabetes Sci Technol. 2007 Jul;1(4):540-8. doi: 10.1177/193229680700100412.
PubMed 19885117
Morrison F, Shubina M, Turchin A. Encounter frequency and serum glucose level, blood pressure, and cholesterol level control in patients with diabetes mellitus. Arch Intern Med. 2011 Sep 26;171(17):1542-50. doi: 10.1001/archinternmed.2011.400.
PubMed 21949161
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.
PubMed 18945920
Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia. 2002 Jul;45(7):937-48. doi: 10.1007/s00125-002-0822-9. Epub 2002 Apr 26.
PubMed 12136392
Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005 Dec;28(12):2948-61. doi: 10.2337/diacare.28.12.2948. No abstract available.
PubMed 16306561
Briscoe VJ, Davis SN. Hypoglycemia in type 1 and type 2 diabetes: physiology, pathophysiology, and management. Clinical Diabetes 24(3): 115-121, 2006.
Seaquist ER, Miller ME, Bonds DE, Feinglos M, Goff DC Jr, Peterson K, Senior P; ACCORD Investigators. The impact of frequent and unrecognized hypoglycemia on mortality in the ACCORD study. Diabetes Care. 2012 Feb;35(2):409-14. doi: 10.2337/dc11-0996. Epub 2011 Dec 16.
PubMed 22179956
Swinnen SG, Hoekstra JB, DeVries JH. Insulin therapy for type 2 diabetes. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S253-9. doi: 10.2337/dc09-S318. No abstract available.
PubMed 19875560
Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, Lafont S, Bergeonneau C, Kassai B, Erpeldinger S, Wright JM, Gueyffier F, Cornu C. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ. 2011 Jul 26;343:d4169. doi: 10.1136/bmj.d4169.
PubMed 21791495
Epidemiology of severe hypoglycemia in the diabetes control and complications trial. The DCCT Research Group. Am J Med. 1991 Apr;90(4):450-9.
PubMed 2012085
Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. doi: 10.1186/1477-7525-5-57.
PubMed 17927832
Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care. 1987 Sep-Oct;10(5):617-21. doi: 10.2337/diacare.10.5.617.
PubMed 3677982
Hajos TR, Pouwer F, Skovlund SE, Den Oudsten BL, Geelhoed-Duijvestijn PH, Tack CJ, Snoek FJ. Psychometric and screening properties of the WHO-5 well-being index in adult outpatients with Type 1 or Type 2 diabetes mellitus. Diabet Med. 2013 Feb;30(2):e63-9. doi: 10.1111/dme.12040.
PubMed 23072401
Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
PubMed 15735199

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12 Week, Parallel, Open-label, Randomized, Multi-center Study Evaluating Use, Safety and Effectiveness of a Web Based Tool vs. Enhanced Usual Therapy of Glargine Titration in T2DM Patients With a 4 Week Safety Extension
ClinicalTrials.gov ID: NCT02540486
Acronym / sponsor ID: INNOVATE / INNOVATE
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes, T2DM
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: LMC Diabetes & Endocrinology Ltd.University, hospital or other
Collaborators: Sanofi
Study start: Dec 2013
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 4 Sep 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.

Detailed description

The secondary objectives of this study are to assess safety, effectiveness, satisfaction and adherence of LTHome use versus Enhanced Usual Therapy glargine titration.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LTHome web tool	Experimental	Other: Long-acting insulin glargine titration web tool (LTHome), Other: Diabetes EducationThe long-acting insulin glargine titration web tool (LTHome) will provide insulin glargine titration suggestions based on user inputted blood glucose readings.
Enhanced Usual Therapy (EUT)	Active comparator	Other: Diabetes EducationThe Enhanced Usual Therapy arm will receive insulin glargine titration instructions that are the usual therapy provided by the physician/HCP, in addition to diabetes education.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patient with type 2 diabetes mellitus (T2DM) between 18 and 75 years old (inclusively) with BMI ≤ 45 kg/m2.
Signed written informed consent
Patients scheduled to: initiate basal insulin treatment or increase their dose of current basal insulin therapy, independently of study participation, because of :
If on basal therapy at screening, must be using a stable dose of insulin glargine x 1 week prior to randomization
Patients with poor blood glucose control defined by:

Key exclusion criteria (17 listed)

Any technical/administrative reason that makes it impossible to include the patient in the study, including closing enrollment due to full enrollment
Patient who has previously participated in any clinical trial investigating the LTHome algorithm
Patient who withdraws consent during screening (starting from signed informed consent form)
Use of systemic steroids in the last 90 days
Conditions/situations:

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
Long-acting insulin glargine titration web tool (LTHome)The LTHome study arm will receive insulin glargine titration instructions from the LTHome web-based tool	Other	LTHome web tool
Diabetes EducationIndividual diabetes education, detailed instructions on the use of the blood glucose monitor and unlimited availability of blood glucose monitoring supplies.	Other	Enhanced Usual Therapy (EUT), LTHome web tool

Primary outcome

Percentage of subjects reaching fasting plasma glucose (FPG) target
Time frame: 12 weeks
The primary outcome is defined as all of the following * At least 4 out of 7 FPG readings done within a 10 day period are within the target range of 5-7.2 mmol/L * Mean glucose for three consecutive prior FPG values is between 5-7.2 mmol/L * There is no severe hypoglycemia during the 7-10 day period (Severe hypoglycemia is defined as third party intervention in management of the hypoglycemia).

20 secondary outcomes

Number of days to first reach fasting plasma glucose target
Time frame: 12 weeks
Number of days in target range after reaching fasting plasma glucose target
Time frame: 12 weeks
Fasting plasma glucose
Time frame: 12 weeks
Hemoglobin A1c (HbA1c)
Time frame: 12 weeks
Rate of documented hypoglycemia in subjects that reach target
Time frame: 12 weeks
Rate of documented hypoglycemia in subjects that do not reach target
Time frame: 12 weeks
Proportion of all patients with hypoglycemia
Time frame: 12 weeks
Frequency of contact with physician/HCP
Time frame: 12 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 12 weeks
Hypoglycemia Fear Survey (HFS)
Time frame: 12 weeks
WHO-5 Well-Being Index
Time frame: 12 weeks
Diabetes Distress Scale
Time frame: 12 weeks
LTHome Patient Satisfaction Survey
Time frame: 12 weeks
Number of days subjects self-monitored their fasting plasma glucose
Time frame: 12 weeks
Number of dose recommendations prior to reaching target - LTHome only
Time frame: 12 weeks
Number of dose recommendations after target is reached - LTHome only
Time frame: 12 weeks
Number of days insulin glargine was taken - LTHome only
Time frame: 12 weeks
Reasons for disregarding LTHome advice - LTHome only
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Serious adverse events
Time frame: 12 weeks

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 4 Sep 2015.
Background: PubMed 15855602Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
Background: PubMed 19885117Strange P. Treat-to-target insulin titration algorithms when initiating long or intermediate acting insulin in type 2 diabetes. J Diabetes Sci Technol. 2007 Jul;1(4):540-8. doi: 10.1177/193229680700100412.
Background: PubMed 21949161Morrison F, Shubina M, Turchin A. Encounter frequency and serum glucose level, blood pressure, and cholesterol level control in patients with diabetes mellitus. Arch Intern Med. 2011 Sep 26;171(17):1542-50. doi: 10.1001/archinternmed.2011.400.
Background: PubMed 18945920Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.
Background: PubMed 12136392Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia. 2002 Jul;45(7):937-48. doi: 10.1007/s00125-002-0822-9. Epub 2002 Apr 26.
Background: PubMed 16306561Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005 Dec;28(12):2948-61. doi: 10.2337/diacare.28.12.2948. No abstract available.
BackgroundBriscoe VJ, Davis SN. Hypoglycemia in type 1 and type 2 diabetes: physiology, pathophysiology, and management. Clinical Diabetes 24(3): 115-121, 2006.
Background: PubMed 22179956Seaquist ER, Miller ME, Bonds DE, Feinglos M, Goff DC Jr, Peterson K, Senior P; ACCORD Investigators. The impact of frequent and unrecognized hypoglycemia on mortality in the ACCORD study. Diabetes Care. 2012 Feb;35(2):409-14. doi: 10.2337/dc11-0996. Epub 2011 Dec 16.
Background: PubMed 19875560Swinnen SG, Hoekstra JB, DeVries JH. Insulin therapy for type 2 diabetes. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S253-9. doi: 10.2337/dc09-S318. No abstract available.
Background: PubMed 21791495Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, Lafont S, Bergeonneau C, Kassai B, Erpeldinger S, Wright JM, Gueyffier F, Cornu C. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ. 2011 Jul 26;343:d4169. doi: 10.1136/bmj.d4169.
Background: PubMed 2012085Epidemiology of severe hypoglycemia in the diabetes control and complications trial. The DCCT Research Group. Am J Med. 1991 Apr;90(4):450-9.
Background: PubMed 17927832Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. doi: 10.1186/1477-7525-5-57.

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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.

Ronnie Aronson, MD principal investigator

LMC Diabetes & Endocrinology Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Long-acting insulin glargine titration web tool (LTHome) and Diabetes Education in people with Type 2 Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.

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 10 inclusion and 17 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 4 Sep 2015. 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 Canada. 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?

Percentage of subjects reaching fasting plasma glucose (FPG) target (time frame: 12 weeks). 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 NCT02540486, which also lists 17 linked publications.

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 4 Sep 2015.