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

NCT03224234 | Completed Results DMC FDA Device

• 1 other identifier: IRB00094393
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Uncontrolled Type 2 Diabetes; Insulclock; Electronic device; Alarm system

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.

  Baseline, 24 weeks

• Change in Diabetes Related Quality of Life (DRQoL) Scores.

  Baseline, 24 weeks

• Change in Mean HbA1c.

  Baseline, 24 weeks

• Number of Episodes of Hypoglycemia.

  Week 0 through week 24.

• Number of Episodes of Severe Hypoglycemia.

  Week 0 through week 24.

Study Arms (2)

Insulclock with feedback (Group A)

EXPERIMENTAL

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

Insulclock without feedback (Group B)

ACTIVE COMPARATOR

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

Interventions

Insulclock with feedback DEVICE

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

Insulclock with feedback (Group A)

Insulclock without feedback DEVICE

Not feedback on insulin administration.

Insulclock without feedback (Group B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Insulcloud S.L.: collaborator

Study Sites (1)

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

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Umpierrez
• Organization: Emory University

geumpie@emory.edu

404-251-8957

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: November 29, 2017
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)