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Trial record 1 of 2 for:    insulclock | diabetes
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A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03224234
Recruitment Status : Completed
First Posted : July 21, 2017
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Insulcoud S.L.
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

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.

Condition or disease Intervention/treatment Phase
Diabetes Device: Insulclock with feedback Device: Insulclock without feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : September 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
Device: Insulclock without feedback
Not feedback on insulin administration.




Primary Outcome Measures :
  1. Number of Insulin Injection Irregularities. [ Time Frame: Week 0 through week 24. ]
    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.

  2. Number of Participants Experiencing Insulclock Device Malfunctions [ Time Frame: Up to 12 weeks ]
    Number of participants experiencing Insulclock device malfunctions are reported


Secondary Outcome Measures :
  1. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score. [ Time Frame: Baseline, 24 weeks ]
    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.

  2. Change in Diabetes Related Quality of Life (DRQoL) Scores. [ Time Frame: Baseline, 24 weeks ]
    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.

  3. Change in Mean HbA1c. [ Time Frame: Baseline, 24 weeks ]
    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.

  4. Number of Episodes of Hypoglycemia. [ Time Frame: Week 0 through week 24. ]
    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).

  5. Number of Episodes of Severe Hypoglycemia. [ Time Frame: Week 0 through week 24. ]
    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.

  6. Change in Daily Fasting Glucose Profile Averages. [ Time Frame: Week 0 through week 24. ]
    Daily fasting glucose profile averages will be recorded to monitor glycemic control.

  7. Change in 7-point Self Monitoring of Blood Glucose (SMBG) Profile. [ Time Frame: 3 to 5 days prior to randomization, up to 24 weeks. ]
    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.

  8. Change in Diabetes Quality of Life Clinical Trial Questionnaire-Revised (DQLCTQ-R) Score [ Time Frame: Baseline, 24 weeks. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224234


Locations
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United States, Georgia
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, 30322
Sponsors and Collaborators
Emory University
Insulcoud S.L.
Investigators
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Principal Investigator: Guillermo Umpierrez, MD Emory University
  Study Documents (Full-Text)

Documents provided by Guillermo Umpierrez, MD, Emory University:
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Responsible Party: Guillermo Umpierrez, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT03224234    
Other Study ID Numbers: IRB00094393
First Posted: July 21, 2017    Key Record Dates
Results First Posted: January 22, 2021
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guillermo Umpierrez, MD, Emory University:
Uncontrolled Type 2 Diabetes
Insulclock
Electronic device
Alarm system
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases