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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Long-acting insulin glargine titration web tool (LTHome)
* Other: Diabetes Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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. Patients who are using, or need to start using, mealtime (Bolus) insulin during the timeframe of the study. Night shift workers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTHome web tool<br>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)<br>* The LTHome study arm will receive insulin glargine titration instructions from the LTHome web-based tool<br>Other: Diabetes Education<br>* Individual diabetes education, detailed instructions on the use of the blood glucose monitor and unlimited availability of blood glucose monitoring supplies.<br>|
| Active Comparator: Enhanced Usual Therapy (EUT)<br>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<br>* Individual diabetes education, detailed instructions on the use of the blood glucose monitor and unlimited availability of blood glucose monitoring supplies.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 12 weeks | 
| Fasting plasma glucose | Fasting plasma glucose values over the entire study period will be summarized by mean and standard deviation | 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. | 12 weeks | 
| Rate of documented hypoglycemia in subjects that reach target |  | 12 weeks | 
| Rate of documented hypoglycemia in subjects that do not reach target |  | 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 | 12 weeks | 
| Frequency of contact with physician/HCP | The number of times subjects contacted their physician/HCP during the study | 12 weeks | 
| Diabetes Treatment Satisfaction Questionnaire (DTSQ) | A questionnaire to assess subject's overall satisfaction with their diabetes treatment | 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 | 12 weeks | 
| WHO-5 Well-Being Index | A questionnaire to measure emotional well-being to screening for likely depression in subjects with diabetes | 12 weeks | 
| Diabetes Distress Scale | A questionnaire to assess diabetes-related emotional distress | 12 weeks | 
| LTHome Patient Satisfaction Survey | LTHome arm only; a questionnaire to measure satisfaction of the use of the LTHome | 12 weeks | 
| Number of days subjects self-monitored their fasting plasma glucose |  | 12 weeks | 
| Number of dose recommendations prior to reaching target - LTHome only |  | 12 weeks | 
| Number of dose recommendations after target is reached - LTHome only |  | 12 weeks | 
| Number of days insulin glargine was taken - LTHome only |  | 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 | 12 weeks | 
| Adverse events |  | 12 weeks | 
| Serious adverse events |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, T2DM