Clinical Drug Experience Knowledgebase

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