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The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA (IN CONTROL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by VU University Medical Center
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
M. Diamant, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01787903
First received: February 6, 2013
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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 Intervention
Type 1 Diabetes Mellitus
Impaired Hypoglycemia Awareness
Hypoglycemia Unawareness
Device: Real-time continuous glucose monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Time spent in the euglycemic range [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    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:
  • Quality of life [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    (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 ] [ Designated as safety issue: No ]
    Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges

  • Hypoglycemic episodes [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    The incidence and duration of hypoglycemic episodes

  • Changes in hypoglycemia awareness score [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    Changes in hypoglycemia awareness score according to Gold et al.


Other Outcome Measures:
  • Glucose variability [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    RT-CGM derived measures of glucose variability, e.g. SD, MODD, CONGA

  • ANS balance [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    The autonomic nervous system balance

  • Sensor wear duration [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    The duration of wear of the RT-CGM device

  • Therapy adjustments [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    The therapy adjustments made by patients during the interventions

  • Hypoglycemia awareness score [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    Hypoglycemia awareness scores according to Clarke et al.

  • RT-CGM satisfaction [ Time Frame: 45 weeks ] [ Designated as safety issue: No ]
    Satisfaction with use of CGM


Estimated Enrollment: 52
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real-time continuous glucose monitor
16 weeks use of a real-time continuous glucose monitor
Device: Real-time continuous glucose monitor
Other Name: MiniMed Paradigm® Veo™-system
Placebo Comparator: Continuous glucose monitor
16 weeks use of a (blinded, retrospective) continuous glucose monitor

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787903

Contacts
Contact: Susanne J Kleijer, MD +31 20 4444588 s.kleijer@vumc.nl
Contact: Michaela Diamant, MD PHD FRCPE +31 20 4440534 m.diamant@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081
Sub-Investigator: Susanne J Kleijer, MD         
Principal Investigator: Michaela Diamant, MD PHD         
Sponsors and Collaborators
VU University Medical Center
Eli Lilly and Company
Investigators
Principal Investigator: Michaela Diamant, MD PhD FRCPE VU University Medical Center
  More Information

No publications provided

Responsible Party: M. Diamant, MD PhD FRCPE, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01787903     History of Changes
Other Study ID Numbers: DC2012INCONTROL01
Study First Received: February 6, 2013
Last Updated: March 6, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
Type 1 diabetes mellitus
Impaired hypoglycemia awareness
Hypoglycemia unawareness
Real-time continuous glucose monitoring
Glucose control

Additional relevant MeSH terms:
Hypoglycemia
Diabetes Mellitus
Diabetes Mellitus, Type 1
Unconsciousness
Autoimmune Diseases
Consciousness Disorders
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014