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Trial record 1 of 1 for:    NCT01787903
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The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA (INCONTROL)

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ClinicalTrials.gov Identifier: NCT01787903
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Erik Serne, VU University Medical Center

Tracking Information
First Submitted Date  ICMJE February 6, 2013
First Posted Date  ICMJE February 11, 2013
Last Update Posted Date July 26, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Time spent in the euglycemic range [ Time Frame: 45 weeks ]
The mean difference in time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), expressed as hours/day between the two 16-week intervention periods, i.e. RT-CGM versus masked CGM in patients with T1DM and IHA.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
  • Quality of life [ Time Frame: 45 weeks ]
    (diabetes-specific) markers of QoL, covering diabetes-related emotional distress (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D) and emotional well-being (WHO-5)
  • Glycemia variables [ Time Frame: 45 weeks ]
    Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges
  • Hypoglycemic episodes [ Time Frame: 45 weeks ]
    The incidence and duration of hypoglycemic episodes
  • Changes in hypoglycemia awareness score [ Time Frame: 45 weeks ]
    Changes in hypoglycemia awareness score according to Gold et al.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 6, 2013)
  • Glucose variability [ Time Frame: 45 weeks ]
    RT-CGM derived measures of glucose variability, e.g. SD, MODD, CONGA
  • ANS balance [ Time Frame: 45 weeks ]
    The autonomic nervous system balance
  • Sensor wear duration [ Time Frame: 45 weeks ]
    The duration of wear of the RT-CGM device
  • Therapy adjustments [ Time Frame: 45 weeks ]
    The therapy adjustments made by patients during the interventions
  • Hypoglycemia awareness score [ Time Frame: 45 weeks ]
    Hypoglycemia awareness scores according to Clarke et al.
  • RT-CGM satisfaction [ Time Frame: 45 weeks ]
    Satisfaction with use of CGM
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA
Official Title  ICMJE The Effects of Real-time Continuous Glucose Monitoring on Glycemia and Quality of Life in Patients With Type 1 Diabetes Mellitus and Impaired Hypoglycemia Awareness
Brief Summary The purpose of this study is to determine what the effects are of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired hypoglycemia awareness.
Detailed Description

The investigators hypothesize that the use of RT-CGM, relative to a control intervention using masked CGM, will result in improvement of various measures of glycemia and indicators of quality of life, reduce the occurrence of hypoglycemia and hyperglycemia and restore hypoglycemia awareness in T1DM patients with IHA. We will test this hypothesis by addressing the following research questions:

What is the effect of 16 weeks of RT-CGM use, versus 16 weeks of CGM use, in patients with T1DM and IHA on

  1. (primary objective:) time spent in euglycemia
  2. (secondary objectives:)

    • (diabetes-specific) markers of QoL, covering diabetes-related emotional distress (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D) and emotional well-being (WHO-5)
    • other glycemia variables, including HbA1c and time spent in hypo- and - hyperglycemia ranges
    • the incidence and duration of hypoglycemic episodes
    • changes in hypoglycemia awareness score according to Gold et al.,
  3. (tertiary objectives:)

    • measures of glucose variability
    • the autonomic nervous system balance
    • the duration of wear of the RT-CGM device
    • patients' therapy adjustments during the interventions
    • hypoglycemia awareness scores according to Clarke et al.
    • satisfaction with use of CGM
    • the number of contact moments not planned according to the study schedule
    • absence of work of patient (and spouse)
    • the global estimated costs of use of health care
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes Mellitus
  • Hypoglycemia Unawareness
Intervention  ICMJE Device: Real-time continuous glucose monitor
Active Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked)
Other Names:
  • MiniMed Paradigm® Veo™-system
  • iPro™2 Continuous Glucose Monitor
Study Arms  ICMJE
  • Active Comparator: Real-time continuous glucose monitor
    16 weeks use of a real-time continuous glucose monitor
    Intervention: Device: Real-time continuous glucose monitor
  • Placebo Comparator: Continuous glucose monitor
    16 weeks use of a (blinded, retrospective) continuous glucose monitor
    Intervention: Device: Real-time continuous glucose monitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2013)
52
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • T1DM, diagnosed according to ADA criteria regardless duration
  • Use of multiple daily injections of insulin (with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion
  • Any HbA1c
  • Age between 18 and 70 years old (inclusive)
  • IHA according to the questionnaire by Gold et al.
  • Performing at least 3 SMBG/day or 21 SMBG/week

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • History of (recent) major renal, liver, or (ischemic) heart disease (including cardiac conduction disorders)
  • Current untreated proliferative diabetic retinopathy
  • Current (treatment for) malignancy
  • Current use of non-selective beta-blockers
  • Current psychiatric disorders, including schizophrenia, bipolar disorder, anorexia nervosa or bulimia nervosa
  • Substance abuse or alcohol abuse (men >21 units/week, women >14 units/week)
  • Current pregnancy or intention to conceive
  • Current use of RT-CGM other than for short term (i.e. diagnostic use or use shorter than 3 consecutive months)
  • Hearing or vision impairment hindering perceiving of glucose display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion of the investigator
  • Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding of the purpose and instructions of the study
  • Participation in another clinical study
  • Known or suspected allergy to trial product or related products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01787903
Other Study ID Numbers  ICMJE DC2012INCONTROL01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erik Serne, VU University Medical Center
Study Sponsor  ICMJE VU University Medical Center
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Erik H Serné, MD PhD VU University Medical Center
PRS Account VU University Medical Center
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP