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

NCT02540486 | Completed

• 1 other identifier: INNOVATE
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes; T2DM

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Secondary Outcomes (20)

• Number of days to first reach fasting plasma glucose target

  12 weeks

• Number of days in target range after reaching fasting plasma glucose target

  12 weeks

• Fasting plasma glucose

  12 weeks

• Hemoglobin A1c (HbA1c)

  12 weeks

• Rate of documented hypoglycemia in subjects that reach target

  12 weeks

Other Outcomes (2)

• Body weight (kg)

  12 weeks

• List of concomitant medications initiated after randomization

  12 weeks

Study Arms (2)

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.

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.

Other: Diabetes Education

Interventions

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

LTHome web tool

Diabetes Education OTHER

Individual diabetes education, detailed instructions on the use of the blood glucose monitor and unlimited availability of blood glucose monitoring supplies.

Enhanced Usual Therapy (EUT); LTHome web tool

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• Sanofi: collaborator

Study Sites (1)

LMC Diabetes & Endocrinology

Toronto, Ontario, M4G 3E8, Canada

Location

Related Publications (17)

• 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.

  PMID: 15855602 BACKGROUND

• 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.

  PMID: 19885117 BACKGROUND

• 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.

  PMID: 21949161 BACKGROUND

• 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.

  PMID: 18945920 BACKGROUND

• 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.

  PMID: 12136392 BACKGROUND

• 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.

  PMID: 16306561 BACKGROUND

• Briscoe VJ, Davis SN. Hypoglycemia in type 1 and type 2 diabetes: physiology, pathophysiology, and management. Clinical Diabetes 24(3): 115-121, 2006.

  BACKGROUND

• 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.

  PMID: 22179956 BACKGROUND

• 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.

  PMID: 19875560 BACKGROUND

• 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.

  PMID: 21791495 BACKGROUND

• Epidemiology of severe hypoglycemia in the diabetes control and complications trial. The DCCT Research Group. Am J Med. 1991 Apr;90(4):450-9.

  PMID: 2012085 BACKGROUND

• 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.

  PMID: 17927832 BACKGROUND

• 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.

  PMID: 3677982 BACKGROUND

• 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.

  PMID: 23072401 BACKGROUND

• 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.

  PMID: 15735199 BACKGROUND

• Petznick A. Insulin management of type 2 diabetes mellitus. Am Fam Physician. 2011 Jul 15;84(2):183-90.

  PMID: 21766768 BACKGROUND

• Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.

  PMID: 24070926 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Ronnie Aronson, MD

  LMC Diabetes & Endocrinology Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, FACE

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 4, 2015
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

CA (1)