A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT03224234|
Recruitment Status : Completed
First Posted : July 21, 2017
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: Insulclock with feedback Device: Insulclock without feedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|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)|
|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|
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.
- 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.
- Number of Participants Experiencing Insulclock Device Malfunctions [ Time Frame: Up to 12 weeks ]Number of participants experiencing Insulclock device malfunctions are reported
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Guillermo Umpierrez, MD||Emory University|