Diabetes Mellitus, Type 1NCT00824148
Use of Real-time Continuous Glucose Monitoring System in Patients With Type 1 Diabetes Mellitus
A study testing Guardian REAL-Time Continuous Glucose Monitoring System and Conventional self-monitoring of plasma glucose in people with Diabetes Mellitus, Type 1, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Guardian REAL-Time Continuous Glucose Monitoring System and Conventional self-monitoring of plasma glucose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2009to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Real-time Continuous Glucose Monitoring System to Control Blood Glucose in Patients With Type 1 Diabetes Mellitus
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Guardian REAL-Time Continuous Glucose Monitoring System, Conventional self-monitoring of plasma glucose
- Keywords
- Real-time glucose monitoring system, HbA1c, Quality of life, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian REAL-Time Continuous Glucose Monitoring SystemDevice
One group will use the glucose monitoring system for 1 month
Conventional self-monitoring of plasma glucoseOther
Finger prick blood glucose measurements
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional self-monitoring of plasma glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of HbA1c concentration
Measured: 1 and 3 months post intervention.
Secondary outcomes (2)
Quality of life assessed by SF-36, DTSQs and DTSQc
Measured: 1 and 3 months post intervention
Number of hypoglycemic events
Measured: 1 and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Kristian J Fougner, MD, Principal investigator, Departement of Endocrinology St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824148
- Sponsor's protocol ID
- 4.2008.1607
- Other IDs
- 19637
- Status last verified
- Feb 2017
- First submitted
- 15 Jan 2009
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22805265
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Real-time Continuous Glucose Monitoring System to Control Blood Glucose in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00824148
- Acronym / sponsor ID
- 4.2008.1607
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Real-time glucose monitoring system, HbA1c, Quality of life, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Diabetes Association
- Study start
- Jan 2009 (actual)
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time glucose monitoring | Experimental | Device: Guardian REAL-Time Continuous Glucose Monitoring SystemUse of Guardian REAL-Time Continuous Glucose Monitoring System, (Medtronic Minimed, Northridge, CA) for 1 month, followed by observation for 2 months. |
| Self-monitoring of plasma glucose | Active comparator | Other: Conventional self-monitoring of plasma glucoseConventional self-monitoring of plasma glucose by finger-prick sampling for 1 month, followed by 1 month observation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guardian REAL-Time Continuous Glucose Monitoring SystemOne group will use the glucose monitoring system for 1 month | Device | Real-time glucose monitoring |
| Conventional self-monitoring of plasma glucoseFinger prick blood glucose measurements | Other | Self-monitoring of plasma glucose |
Primary outcome
Level of HbA1c concentration
Time frame: 1 and 3 months post intervention.
2 secondary outcomes
Quality of life assessed by SF-36, DTSQs and DTSQc
Time frame: 1 and 3 months post intervention
Number of hypoglycemic events
Time frame: 1 and 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Results publication: PubMed 22805265Langeland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian J Fougner, MD principal investigator
Departement of Endocrinology St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardian REAL-Time Continuous Glucose Monitoring System and Conventional self-monitoring of plasma glucose in people with Diabetes Mellitus, Type 1, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of HbA1c concentration (time frame: 1 and 3 months post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00824148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.