NCT01787903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

3.2 years

First QC Date

February 6, 2013

Last Update Submit

July 25, 2017

Conditions

Type 1 Diabetes MellitusHypoglycemia Unawareness

Keywords

Type 1 diabetes mellitusHypoglycemia unawarenessReal-time continuous glucose monitoringGlucose control

Outcome Measures

Primary Outcomes (1)

  • Time spent in the euglycemic range

    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 Outcomes (4)

  • Quality of life

    45 weeks

  • Glycemia variables

    45 weeks

  • Hypoglycemic episodes

    45 weeks

  • Changes in hypoglycemia awareness score

    45 weeks

Other Outcomes (6)

  • Glucose variability

    45 weeks

  • ANS balance

    45 weeks

  • Sensor wear duration

    45 weeks

  • +3 more other outcomes

Study Arms (2)

Real-time continuous glucose monitor

ACTIVE COMPARATOR

16 weeks use of a real-time continuous glucose monitor

Device: Real-time continuous glucose monitor

Continuous glucose monitor

PLACEBO COMPARATOR

16 weeks use of a (blinded, retrospective) continuous glucose monitor

Device: Real-time continuous glucose monitor

Interventions

Real-time continuous glucose monitorDEVICE

Active Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked)

Also known as: MiniMed Paradigm® Veo™-system, iPro™2 Continuous Glucose Monitor
Continuous glucose monitorReal-time continuous glucose monitor

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081, Netherlands

Location

Related Publications (2)

  • van Beers CA, DeVries JH, Kleijer SJ, Smits MM, Geelhoed-Duijvestijn PH, Kramer MH, Diamant M, Snoek FJ, Serne EH. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial. Lancet Diabetes Endocrinol. 2016 Nov;4(11):893-902. doi: 10.1016/S2213-8587(16)30193-0. Epub 2016 Sep 15.

    PMID: 27641781DERIVED

  • van Beers CA, Kleijer SJ, Serne EH, Geelhoed-Duijvestijn PH, Snoek FJ, Kramer MH, Diamant M. Design and rationale of the IN CONTROL trial: the effects of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired awareness of hypoglycemia. BMC Endocr Disord. 2015 Aug 21;15:42. doi: 10.1186/s12902-015-0040-3.

    PMID: 26292721DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Erik H Serné, MD PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 11, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

NL(1)