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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
139
The LTHome study arm will receive insulin glargine titration instructions from the LTHome web-based tool
Individual diabetes education, detailed instructions on the use of the blood glucose monitor and unlimited availability of blood glucose monitoring supplies.
LMC Diabetes & Endocrinology
Toronto, Ontario, Canada
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).
Time frame: 12 weeks
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.
Time frame: 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)
Time frame: 12 weeks
Fasting plasma glucose
Fasting plasma glucose values over the entire study period will be summarized by mean and standard deviation
Time frame: 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.
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
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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
Time frame: 12 weeks
Frequency of contact with physician/HCP
The number of times subjects contacted their physician/HCP during the study
Time frame: 12 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
A questionnaire to assess subject's overall satisfaction with their diabetes treatment
Time frame: 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
Time frame: 12 weeks
WHO-5 Well-Being Index
A questionnaire to measure emotional well-being to screening for likely depression in subjects with diabetes
Time frame: 12 weeks
Diabetes Distress Scale
A questionnaire to assess diabetes-related emotional distress
Time frame: 12 weeks
LTHome Patient Satisfaction Survey
LTHome arm only; a questionnaire to measure satisfaction of the use of the LTHome
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
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
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Serious adverse events
Time frame: 12 weeks