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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Hypoglycemia Unawareness Device: Real-time continuous glucose monitor Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Real-time continuous glucose monitor
16 weeks use of a real-time continuous glucose monitor
 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
Placebo Comparator: Continuous glucose monitor
16 weeks use of a (blinded, retrospective) continuous glucose monitor
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Glycemia variables [ Time Frame: 45 weeks ]
    Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges

  3. Hypoglycemic episodes [ Time Frame: 45 weeks ]
    The incidence and duration of hypoglycemic episodes

  4. Changes in hypoglycemia awareness score [ Time Frame: 45 weeks ]
    Changes in hypoglycemia awareness score according to Gold et al.


Other Outcome Measures:
  1. Glucose variability [ Time Frame: 45 weeks ]
    RT-CGM derived measures of glucose variability, e.g. SD, MODD, CONGA

  2. ANS balance [ Time Frame: 45 weeks ]
    The autonomic nervous system balance

  3. Sensor wear duration [ Time Frame: 45 weeks ]
    The duration of wear of the RT-CGM device

  4. Therapy adjustments [ Time Frame: 45 weeks ]
    The therapy adjustments made by patients during the interventions

  5. Hypoglycemia awareness score [ Time Frame: 45 weeks ]
    Hypoglycemia awareness scores according to Clarke et al.

  6. RT-CGM satisfaction [ Time Frame: 45 weeks ]
    Satisfaction with use of CGM


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01787903


Locations
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Netherlands
VU University Medical Center
Amsterdam, Noord-Holland, Netherlands, 1081
Sponsors and Collaborators
VU University Medical Center
Eli Lilly and Company
Investigators
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Principal Investigator: Erik H Serné, MD PhD VU University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Erik Serne, MD PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01787903    
Other Study ID Numbers: DC2012INCONTROL01
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Keywords provided by Erik Serne, VU University Medical Center:
Type 1 diabetes mellitus
Hypoglycemia unawareness
Real-time continuous glucose monitoring
Glucose control
Additional relevant MeSH terms:
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Unconsciousness
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases