Clinical trial NCT00824148: Use of Real-time Continuous Glucose Monitoring System in Patients With Type 1 Diabetes Mellitus
Official title: Use of Real-time Continuous Glucose Monitoring System to Control Blood Glucose in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Real-time glucose monitoring system
HbA1c
Quality of life
Hypoglycemia
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Diabetes Association
First posted: 2009-01-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a real-time continuous glucose monitoring system is able to improve HbA1c in patients suffering from type 1 diabetes compared to conventional finger prick glucose measurements. In addition it will investigate whether number of episodes with serious hypoglycemia is changed in those same patients, and whether quality of life (health status and treatment satisfaction) increases.


Eligibility criteria: Inclusion Criteria:

1. Diabetes Mellitus, Type 1 \> 3 years.
2. For practical reasons patients should live in Trondheim, Malvik, Melhus or Klæbu.
3. Level of HbA1c (measured by DCA 2000) between 7 and 10 % and/or experience blood glucose \< 3 mmol/L (verified by finger-prick measurement) at least once a week and/or at least one episode with serious hypoglycemia the previous half a year.(Defined as need of help from others)
4. Only patients who use insulin pumps or multi-injection regime (=3 daily injections with short term acting insulin or insulin analogue + at lest one daily injection with NPH-insulin or long term acting insulin analogue.

Exclusion Criteria:

1. Patients with other diseases such as untreated hypothyroidism, adrenal gland failure, celiac disease, renal failure, unstable coronary heart disease, serious psychiatric disorder, or mental retardation.
2. Patients who are not able to learn how to use the continuous glucose monitoring system given a reasonable amount of effort.
3. Patients who are not able to do the glucose measurements, insulin dose change and diary notes which the study demands.
4. Unsuited for participating from any other cause.

Primary outcomes:
measure: Level of HbA1c concentration
timeFrame: 1 and 3 months post intervention.
Secondary outcomes:
measure: Quality of life assessed by SF-36, DTSQs and DTSQc
timeFrame: 1 and 3 months post intervention
measure: Number of hypoglycemic events
timeFrame: 1 and 3 months post intervention
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Endocrinology, St. Olavs Hospital
Study officials:
affiliation: Departement of Endocrinology St. Olavs Hospital
name: Kristian J Fougner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langeland LB, Salvesen O, Selle H, Carlsen SM, Fougner KJ. Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial. Int J Clin Pract. 2012 Aug;66(8):741-747. doi: 10.1111/j.1742-1241.2012.02947.x.