Clinical trial NCT03224234: A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Official title: A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Uncontrolled Type 2 Diabetes
Insulclock
Electronic device
Alarm system
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Insulcloud S.L.
First posted: 2017-07-21
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Insulin Injection Irregularities.
timeFrame: Week 0 through week 24.
measure: Number of Participants Experiencing Insulclock Device Malfunctions
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.
timeFrame: Baseline, 24 weeks
measure: Change in Diabetes Related Quality of Life (DRQoL) Scores.
timeFrame: Baseline, 24 weeks
measure: Change in Mean HbA1c.
timeFrame: Baseline, 24 weeks
measure: Number of Episodes of Hypoglycemia.
timeFrame: Week 0 through week 24.
measure: Number of Episodes of Severe Hypoglycemia.
timeFrame: Week 0 through week 24.
measure: Change in Daily Fasting Glucose Profile Averages.
timeFrame: Week 0 through week 24.
measure: Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile.
timeFrame: 3 to 5 days prior to randomization, up to 24 weeks.
measure: Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score
timeFrame: Baseline, 24 weeks.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic, Emory University Hospital (non-CRN), Emory University Hospital Clinical Research Network, Emory University Hospital Midtown, Grady Health System (non-CRN)
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: