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

Primary Purpose

Type 1 Diabetes Mellitus, Hypoglycemia Unawareness

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Real-time continuous glucose monitor
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes mellitus, Hypoglycemia unawareness, Real-time continuous glucose monitoring, Glucose control

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VU University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Real-time continuous glucose monitor

Continuous glucose monitor

Arm Description

16 weeks use of a real-time continuous glucose monitor

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life
(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
Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges
Hypoglycemic episodes
The incidence and duration of hypoglycemic episodes
Changes in hypoglycemia awareness score
Changes in hypoglycemia awareness score according to Gold et al.

Full Information

First Posted
February 6, 2013
Last Updated
July 25, 2017
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01787903
Brief Title
The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA
Acronym
INCONTROL
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 Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 (primary objective:) time spent in euglycemia (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., (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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Hypoglycemia Unawareness
Keywords
Type 1 diabetes mellitus, Hypoglycemia unawareness, Real-time continuous glucose monitoring, Glucose control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time continuous glucose monitor
Arm Type
Active Comparator
Arm Description
16 weeks use of a real-time continuous glucose monitor
Arm Title
Continuous glucose monitor
Arm Type
Placebo Comparator
Arm Description
16 weeks use of a (blinded, retrospective) continuous glucose monitor
Intervention Type
Device
Intervention Name(s)
Real-time continuous glucose monitor
Other Intervention Name(s)
MiniMed Paradigm® Veo™-system, iPro™2 Continuous Glucose Monitor
Intervention Description
Active Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked)
Primary Outcome Measure Information:
Title
Time spent in the euglycemic range
Description
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.
Time Frame
45 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
(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)
Time Frame
45 weeks
Title
Glycemia variables
Description
Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges
Time Frame
45 weeks
Title
Hypoglycemic episodes
Description
The incidence and duration of hypoglycemic episodes
Time Frame
45 weeks
Title
Changes in hypoglycemia awareness score
Description
Changes in hypoglycemia awareness score according to Gold et al.
Time Frame
45 weeks
Other Pre-specified Outcome Measures:
Title
Glucose variability
Description
RT-CGM derived measures of glucose variability, e.g. SD, MODD, CONGA
Time Frame
45 weeks
Title
ANS balance
Description
The autonomic nervous system balance
Time Frame
45 weeks
Title
Sensor wear duration
Description
The duration of wear of the RT-CGM device
Time Frame
45 weeks
Title
Therapy adjustments
Description
The therapy adjustments made by patients during the interventions
Time Frame
45 weeks
Title
Hypoglycemia awareness score
Description
Hypoglycemia awareness scores according to Clarke et al.
Time Frame
45 weeks
Title
RT-CGM satisfaction
Description
Satisfaction with use of CGM
Time Frame
45 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik H Serné, MD PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27641781
Citation
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.
Results Reference
derived
PubMed Identifier
26292721
Citation
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.
Results Reference
derived

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

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