A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes

Study Overview
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Brief Summary
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Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming.

Detailed Description
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Diabetes is arguably the most urgent healthcare challenge of the 21st century. Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming. The Insulclock's real time memory and alert system are likely to improve treatment adherence, patient's satisfaction, and quality of life measures, which may improve glycemic control in insulin treated patients with Type 2 Diabetes.

Official Title
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A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Device: Insulclock with feedback
* Device: Insulclock without feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 80 years Diagnosis of T2D Screening HbA1c ≥ 7.5% to ≤ 11% Continuous treatment with one or more oral antidiabetic agents, for at least 2 months Continuous treatment with daily basal insulin (NPH, glargine U100 or detemir), for at least 2 months, (insulin dose ≤0.5U/Kg/day) If patients are on combination therapy of basal insulin and GLP1-RA, the dose of GLP-1 RA should be stable for the past three months. Owns a smartphone - Apple iPhone, Samsung Galaxy models Signed, informed consent and HIPAA documentation Subjects' ability to self-administer insulin, use the device and complete subject reported outcomes instruments Subjects' ability & willingness to adhere to and be compliant with study protocol Exclusion Criteria: Refusal or inability to give informed consent to participate in the study Subject is currently taking or was treated with glargine U300 insulin, degludec, insulin dose greater than 0.5 U/kg/day during the previous three months Subject treated with prandial insulin or premixed formulations during the previous three months Impaired renal function as shown by, but not limited to, eGFR < 30 ml/min. Muscle weakness or hemiparesis related to previous stroke or myelopathy resulting in incoordination, muscle weakness and inability to use pen device for insulin administration History of diabetic ketoacidosis during the previous 6 months Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of the normal range History of hypoglycemia unawareness Pregnancy or lactation Known hypersensitivity to insulin glargine or any of the components Any malignancy within the last 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ Current drug addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years Diagnosis of dementia Severe gastrointestinal diseases including gastroparesis Cardiac status NYHA III-IV Acute infection Patients on or planning to receive long term oral or injectable steroid treatment for greater than 10 days Patient schedule to undergo general surgery during the next 6 months Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulclock with feedback (Group A)<br>Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm. | Device: Insulclock with feedback<br>* Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.<br>|
| Active Comparator: Insulclock without feedback (Group B)<br>Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. | Device: Insulclock without feedback<br>* Not feedback on insulin administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Insulin Injection Irregularities. | Number of insulin injection irregularities (omission, mistiming and dosing) will be registered on the Insulclock device, and data will be retrieved during each clinic visit to monitor treatment adherence. | Week 0 through week 24. | 
| Number of Participants Experiencing Insulclock Device Malfunctions | Number of participants experiencing Insulclock device malfunctions are reported | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score. | The amplitude of the score on the DTSQc gives the degree of change in satisfaction while the direction (positive or negative) will provide guidance on the preference of one device over the other. DTSQc contains eight items scored on 7-point scales; scores range from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change. | Baseline, 24 weeks | 
| Change in Diabetes Related Quality of Life (DRQoL) Scores. | DRQoL is a composite score, consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), and Problem Areas in Diabetes (PAID) questionnaire score. ITEQ includes 7 domains: leisure activities (4 items), psychological barriers (2 items), handling (5 items), diabetes control (6 items), dependence (5 items), weight control (3 items), sleep (2 items); + 1 additional item assigned to assess overall satisfaction with current insulin therapy regimen. The PAID contains 20 items that describe negative emotions related to diabetes commonly experienced by patients with diabetes. Each question has five possible answers with a value from 0 to 4, with 0 representing no problem and 4 a serious problem. The scores are added up and multiplied by 1.25, generating a total score between 0 - 100. | Baseline, 24 weeks | 
| Change in Mean HbA1c. | HbA1c is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The test is limited to a three-month average because the lifespan of a red blood cell is four months (120 days). Change in mean HbA1cas will be measure and recorded to monitor glycemic control. | Baseline, 24 weeks | 
| Number of Episodes of Hypoglycemia. | Number of episodes of hypoglycemia will be recorded. For this study, symptomatic hypoglycemia is defined as an event with typical symptoms (i.e., sweating, palpitation, and feeling of hunger) with or without confirmation by plasma glucose <54 mg/dl (3.9 mmol/L). | Week 0 through week 24. | 
| Number of Episodes of Severe Hypoglycemia. | Number of episodes of severe hypoglycemia will be recorded.Severe hypoglycemia is defined as episodes necessitating assistance and associated with measured plasma glucose < 40 mg/dl (2.2 mmol/L), or with prompt recovery after administration of carbohydrates, glucagon, or other resuscitative actions. | Week 0 through week 24. | 
| Change in Daily Fasting Glucose Profile Averages. | Daily fasting glucose profile averages will be recorded to monitor glycemic control. | Week 0 through week 24. | 
| Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile. | SMBG refers to home blood glucose testing for people with diabetes. 7-point SMBG profile include fasting, before meals, 2 hours after meals, and bedtime. | 3 to 5 days prior to randomization, up to 24 weeks. | 
| Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score | The DQLCTQ-R is a 57-item scale that comprises 8 dimensions: physical function, energy/fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility, and frequency of symptoms. | Baseline, 24 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncontrolled Type 2 Diabetes, Insulclock, Electronic device, Alarm system