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

July 25, 2017 updated by: Erik Serne, Amsterdam UMC, location VUmc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081
        • VU University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
45 weeks
Glycemia variables
Time Frame: 45 weeks
Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges
45 weeks
Hypoglycemic episodes
Time Frame: 45 weeks
The incidence and duration of hypoglycemic episodes
45 weeks
Changes in hypoglycemia awareness score
Time Frame: 45 weeks
Changes in hypoglycemia awareness score according to Gold et al.
45 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose variability
Time Frame: 45 weeks
RT-CGM derived measures of glucose variability, e.g. SD, MODD, CONGA
45 weeks
ANS balance
Time Frame: 45 weeks
The autonomic nervous system balance
45 weeks
Sensor wear duration
Time Frame: 45 weeks
The duration of wear of the RT-CGM device
45 weeks
Therapy adjustments
Time Frame: 45 weeks
The therapy adjustments made by patients during the interventions
45 weeks
Hypoglycemia awareness score
Time Frame: 45 weeks
Hypoglycemia awareness scores according to Clarke et al.
45 weeks
RT-CGM satisfaction
Time Frame: 45 weeks
Satisfaction with use of CGM
45 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Erik H Serné, MD PhD, Amsterdam Umc, Location Vumc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC2012INCONTROL01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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