Type 1 Diabetes Mellitus | The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA
Type 1 Diabetes Mellitus research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type 1 Diabetes Mellitus
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Real-time continuous glucose monitorActive Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Real-time continuous glucose monitor16 weeks use of a real-time continuous glucose monitor
Continuous glucose monitor16 weeks use of a (blinded, retrospective) continuous glucose monitor
Start Date: February 2013
Completed Date: April 2016
Primary Outcome: Time spent in the euglycemic range
Secondary Outcome: Quality of life
Study sponsors, principal investigator, and references
Principal Investigator: Erik H Serné, MD PhD
Lead Sponsor: VU University Medical Center
Collaborator: Eli Lilly and Company