NCT00824148

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 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

January 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

January 15, 2009

Last Update Submit

February 23, 2017

Conditions

Diabetes Mellitus, Type 1

Keywords

Real-time glucose monitoring systemHbA1cQuality of lifeHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Level of HbA1c concentration

    1 and 3 months post intervention.

Secondary Outcomes (2)

  • Quality of life assessed by SF-36, DTSQs and DTSQc

    1 and 3 months post intervention

  • Number of hypoglycemic events

    1 and 3 months post intervention

Study Arms (2)

Real-time glucose monitoring

EXPERIMENTAL

Use of Guardian REAL-Time Continuous Glucose Monitoring System, (Medtronic Minimed, Northridge, CA) for 1 month, followed by observation for 2 months.

Device: Guardian REAL-Time Continuous Glucose Monitoring System

Self-monitoring of plasma glucose

ACTIVE COMPARATOR

Conventional self-monitoring of plasma glucose by finger-prick sampling for 1 month, followed by 1 month observation.

Other: Conventional self-monitoring of plasma glucose

Interventions

Guardian REAL-Time Continuous Glucose Monitoring SystemDEVICE

One group will use the glucose monitoring system for 1 month

Real-time glucose monitoring
Conventional self-monitoring of plasma glucoseOTHER

Finger prick blood glucose measurements

Self-monitoring of plasma glucose

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetes Mellitus, Type 1 \> 3 years.
  • For practical reasons patients should live in Trondheim, Malvik, Melhus or Klæbu.
  • 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)
  • 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.

You may not qualify if:

  • 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.
  • Patients who are not able to learn how to use the continuous glucose monitoring system given a reasonable amount of effort.
  • Patients who are not able to do the glucose measurements, insulin dose change and diary notes which the study demands.
  • Unsuited for participating from any other cause.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, St. Olavs Hospital

Trondheim, N-7006, Norway

Location

Related Publications (1)

  • 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.

    PMID: 22805265RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kristian J Fougner, MD

    Departement of Endocrinology St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

NO(1)