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

NCT ID: NCT03224234

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-29
• Study Completion Date: 2019-09-18

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulclock with feedback (Group A)

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.

Group Type: EXPERIMENTAL

Insulclock with feedback

Intervention Type: DEVICE

Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.

Insulclock without feedback (Group B)

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.

Group Type: ACTIVE_COMPARATOR

Insulclock without feedback

Intervention Type: DEVICE

Not feedback on insulin administration.

Interventions

Insulclock with feedback

Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.

Intervention Type: DEVICE

Insulclock without feedback

Not feedback on insulin administration.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insulcloud S.L.

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Clinic, Emory University Hospital (non-CRN), Emory University Hospital Clinical Research Network, Emory University Hospital Midtown, Grady Health System (non-CRN)

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00094393

Identifier Type: -

Identifier Source: org_study_id