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

Type 1 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787903
• Other study ID #: DC2012INCONTROL01
• Status: Completed
• Phase: N/A
• First received: February 6, 2013
• Last updated: July 25, 2017
• Start date: February 2013
• Est. completion date: April 2016

Study information

• Verified date: July 2017
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Hypoglycemia Unawareness
• Type 1 Diabetes Mellitus
• Unconsciousness

Intervention

Device:
• Real-time continuous glucose monitor
Active Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked)

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
VU University Medical Center	Eli Lilly and Company

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glucose variability	RT-CGM derived measures of glucose variability, e.g. SD, MODD, CONGA	45 weeks
Other	ANS balance	The autonomic nervous system balance	45 weeks
Other	Sensor wear duration	The duration of wear of the RT-CGM device	45 weeks
Other	Therapy adjustments	The therapy adjustments made by patients during the interventions	45 weeks
Other	Hypoglycemia awareness score	Hypoglycemia awareness scores according to Clarke et al.	45 weeks
Other	RT-CGM satisfaction	Satisfaction with use of CGM	45 weeks
Primary	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	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)	45 weeks
Secondary	Glycemia variables	Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges	45 weeks
Secondary	Hypoglycemic episodes	The incidence and duration of hypoglycemic episodes	45 weeks
Secondary	Changes in hypoglycemia awareness score	Changes in hypoglycemia awareness score according to Gold et al.	45 weeks