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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224234
• Other study ID #: IRB00094393
• Status: Completed
• Phase: N/A
• Start date: November 29, 2017
• Est. completion date: September 18, 2019

Study information

• Verified date: January 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Insulclock with feedback
Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
• Insulclock without feedback
Not feedback on insulin administration.

Locations

Country	Name	City	State
United States	Emory Clinic, Emory University Hospital (non-CRN), Emory University Hospital Clinical Research Network, Emory University Hospital Midtown, Grady Health System (non-CRN)	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Insulcoud S.L.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Number of Participants Experiencing Insulclock Device Malfunctions	Number of participants experiencing Insulclock device malfunctions are reported	Up to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	Change in Daily Fasting Glucose Profile Averages.	Daily fasting glucose profile averages will be recorded to monitor glycemic control.	Week 0 through week 24.
Secondary	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.
Secondary	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.