Type 1 DiabetesPhase 3NCT00554281
Using Glucose Sensors to Prevent Hypoglycemia
A Phase 3 study testing Use of glucose sensor (Paradigm Guardian) in people with Type 1 Diabetes and Hypoglycemia, run by University of Alberta at 2 sites in Canada.
Trial summary
Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who strive for good glycemic control. In some patients there is a loss of awareness of hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Use of glucose sensor (Paradigm Guardian)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2006to Aug 2008
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 Diabetes Mellitus confirmed by C-peptide <0.10 nmol/L
- age 18 - 70 yrs.
- HYPO score >423
- normal TSH, serum cortisol and anti-transglutaminase (ATTG)
Who cannot join
- current diagnosis of cancer
- planning a pregnancy
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
University of Alberta
Edmonton, Alberta, T6G 2S2
About this study
Official title: Paradigm Real Time Continuous Glucose Monitoring Device for the Prevention of Hypoglycemia
Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who strive for good glycemic control. In some patients there is a loss of awareness of hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Such a situation may carry risks that the patient may harm him or her self. Medtronic has recently developed a continuous glucose sensor that determines the glucose level every 3 minutes using a subcutaneous sensor and transmits the information to a remote device (Paradigm RT) that may be worn or left close by eg on a bedside table. The device may be programmed to alarm for a rapidly falling glucose or for low glucose levels.
We propose to use this in 16 patients with severe hypoglycemia as evidenced by a high HYPO score and see if we can decrease the number of hypoglycemic reactions and document this improvement with a better HYPO score.
Read the detailed description
Sixteen patients with Type 1 diabetes (as defined by: onset under the age of 25, lean at time of onset, continuous insulin use, and/or history of ketoacidosis and C-peptide negative), with a HYPO score over the seventy-fifth percentile (>423), will be approached and offered the study.
The study will be conducted over a three month time-frame. The first month will be a run-in period for participants to collect four weeks of glucose readings and information about their hypoglycemic events. These records will be used to calculate the baseline modified HYPO score. Patients will be screened during the first month for thyroid disease, celiac disease and Addison's disease.
During the second month they will meet with the study nurse for an intensive instruction period on the use of the Paradigm RT sensor. They will spend this month practicing to use the sensor and confirming they can use it adequately.
During the final month they will wear the sensor and collect glucose and hypoglycemia records for calculation of the final modified HYPO score.
The end point will be the change from the baseline modified HYPO score to the final four week HYPO score and this would be used to identify any improvement.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Use of glucose sensor (Paradigm Guardian)
- Keywords
- Type 1 diabetes, Hypoglycemia, Glucose sensor
- 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.
Use of glucose sensor (Paradigm Guardian)Device
Also called Paradigm Guardian glucose sensor
Use glucose sensor to prevent episodes of severe hypoglycemia
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Run in period |
| B | Experimental | Not described Receives: Device: Use of glucose sensor (Paradigm Guardian) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in HYPO score
Measured: 3 months
Secondary outcomes (2)
Number of episodes of severe hypoglycemia
Measured: 3 months
Number of patients who decide to continue using the device
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionAug 2008
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 Type 1 DiabetesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edmond A Ryan, University of Alberta
- Investigators
- Edmond A Ryan, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554281
- Sponsor's protocol ID
- UAHREB6344
- Status last verified
- Sep 2011
- First submitted
- 2 Nov 2007
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ryan EA, Germsheid J. Use of continuous glucose monitoring system in the management of severe hypoglycemia. Diabetes Technol Ther. 2009 Oct;11(10):635-9. doi: 10.1089/dia.2009.0042.
PubMed 19821755
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paradigm Real Time Continuous Glucose Monitoring Device for the Prevention of Hypoglycemia
- ClinicalTrials.gov ID
- NCT00554281
- Acronym / sponsor ID
- UAHREB6344
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- Type 1 diabetes, Hypoglycemia, Glucose sensor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Nov 2007 (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.
Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who strive for good glycemic control. In some patients there is a loss of awareness of hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Such a situation may carry risks that the patient may harm him or her self. Medtronic has recently developed a continuous glucose sensor that determines the glucose level every 3 minutes using a subcutaneous sensor and transmits the information to a remote device (Paradigm RT) that may be worn or left close by eg on a bedside table. The device may be programmed to alarm for a rapidly falling glucose or for low glucose levels.
We propose to use this in 16 patients with severe hypoglycemia as evidenced by a high HYPO score and see if we can decrease the number of hypoglycemic reactions and document this improvement with a better HYPO score.
Detailed description
Sixteen patients with Type 1 diabetes (as defined by: onset under the age of 25, lean at time of onset, continuous insulin use, and/or history of ketoacidosis and C-peptide negative), with a HYPO score over the seventy-fifth percentile (>423), will be approached and offered the study.
The study will be conducted over a three month time-frame. The first month will be a run-in period for participants to collect four weeks of glucose readings and information about their hypoglycemic events. These records will be used to calculate the baseline modified HYPO score. Patients will be screened during the first month for thyroid disease, celiac disease and Addison's disease.
During the second month they will meet with the study nurse for an intensive instruction period on the use of the Paradigm RT sensor. They will spend this month practicing to use the sensor and confirming they can use it adequately.
During the final month they will wear the sensor and collect glucose and hypoglycemia records for calculation of the final modified HYPO score.
The end point will be the change from the baseline modified HYPO score to the final four week HYPO score and this would be used to identify any improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Run in period |
| B | Experimental | Device: Use of glucose sensor (Paradigm Guardian) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 Diabetes Mellitus confirmed by C-peptide <0.10 nmol/L
- age 18 - 70 yrs.
- HYPO score >423
- normal TSH, serum cortisol and anti-transglutaminase (ATTG)
Key exclusion criteria (3 listed)
- current diagnosis of cancer
- planning a pregnancy
- Inability to give informed consent
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 |
|---|---|---|
| Use of glucose sensor (Paradigm Guardian)Also: Paradigm Guardian glucose sensorUse glucose sensor to prevent episodes of severe hypoglycemia | Device | B |
Primary outcome
Decrease in HYPO score
Time frame: 3 months
2 secondary outcomes
Number of episodes of severe hypoglycemia
Time frame: 3 months
Number of patients who decide to continue using the device
Time frame: 3 months
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 13 Sep 2011.
- Results publication: PubMed 19821755Ryan EA, Germsheid J. Use of continuous glucose monitoring system in the management of severe hypoglycemia. Diabetes Technol Ther. 2009 Oct;11(10):635-9. doi: 10.1089/dia.2009.0042.
Related trials for Type 1 Diabetes
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
Diabetes Mellitus, Type 1
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
RecruitingPhase 4
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
Chronic Kidney Diseases, Type 2 Diabetes Mellitus
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.
Edmond A Ryan, MD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Use of glucose sensor (Paradigm Guardian) in people with Type 1 Diabetes and Hypoglycemia, run by University of Alberta at 2 sites in Canada.
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 3 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 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decrease in HYPO score (time frame: 3 months). 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 NCT00554281, 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 13 Sep 2011; AzTrials last refreshed its copy on 29 Oct 2026.