Type 1 Diabetes MellitusPhase 4NCT00360984
Prevention of Severe Hypoglycemia in Type 1 Diabetes
A Phase 4 study testing insulin glargine and continuous subcutaneous insulin infusion in people with Type 1 Diabetes Mellitus, run by Newcastle University at 1 site in United Kingdom.
Trial summary
Severe hypoglycaemia leading to collapse without warning is one of the most-feared complications for those with Type 1 diabetes. The aim of this study is to determine whether detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous insulin regime or continuous insulin regime can… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- insulin glargine and continuous subcutaneous insulin infusion
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2003to Sep 2004
- Phase
- Phase 4
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 1 diabetes
- recurrent severe hypoglycemia within the preceding 6 months
- attending the Newcastle Diabetes Centre
Who cannot join
- previous use of rapid- and long-acting insulin analogs used in an multiple daily insulin injection regimen
- previous use of continuous subcutaneous insulin infusion pump
- alcohol or drug abuse
- seizures unrelated to hypoglycemia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle Diabetes Centre
Newcastle, Tyne and Wear, NE4 6BE
About this study
Official title: Can Hypoglycaemia Awareness Be Restored in Individuals With Type 1 Diabetes and Severe Hypoglycaemia Employing Optimised Subcutaneous Insulin Regime or Continuous Subcutaneous Insulin Infusion Pump
Severe hypoglycaemia leading to collapse without warning is one of the most-feared complications for those with Type 1 diabetes. The aim of this study is to determine whether detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1 diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia; or continuous subcutaneous insulin infusion. Symptomatic experience and severity of hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals, response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It is envisaged that successful prevention of hypoglycaemia by one or more interventions may reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.
Read the detailed description
The unifying objective of the proposed unblinded randomized prospective study is to determine whether hypoglycaemia awareness in Type 1 diabetes can be restored by rigorous avoidance of hypoglycaemia addressed by one of the following interventions:
- A non-targeted approach whereby pre-prandial glycaemic targets are raised from 4.5-7mmol/L to 7.2-8.3mmol/L and hypoglycaemia is rigorously avoided without specific alterations in subcutaneous insulin regime5
- Optimisation of subcutaneous insulin regime employing pre-prandial short-acting insulin analogue in combination with once daily insulin Glargine targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
- Insulin delivery by external pump (continuous subcutaneous insulin infusion) targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- insulin glargine, continuous subcutaneous insulin infusion
- Keywords
- CSII, insulin analog, severe hypoglycaemia, altered hypoglycaemia awareness, diabetes quality of life, CGMS
- 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.
insulin glargineDrug
continuous subcutaneous insulin infusionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of severe hypoglycemia
Secondary outcomes (6)
incidence of mild symptomatic hypoglycemia
HbA1C
Continuous Subcutaneous Glucose Monitoring System profiles
Altered Hypoglycemia Awareness survey
Hypoglycemia Fear Survey
Diabetes Quality Of Life of questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startMay 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360984
- Sponsor's protocol ID
- 4044
- Status last verified
- Jul 2006
- First submitted
- 4 Aug 2006
- Last updated
- 7 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Hypoglycaemia Awareness Be Restored in Individuals With Type 1 Diabetes and Severe Hypoglycaemia Employing Optimised Subcutaneous Insulin Regime or Continuous Subcutaneous Insulin Infusion Pump
- ClinicalTrials.gov ID
- NCT00360984
- Acronym / sponsor ID
- 4044
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- CSII, insulin analog, severe hypoglycaemia, altered hypoglycaemia awareness, diabetes quality of life, CGMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle Primary Care Trust, Sanofi, Medtronic
- Study start
- May 2003
- Study completion
- Sep 2004
- First posted
- 7 Aug 2006 (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.
Severe hypoglycaemia leading to collapse without warning is one of the most-feared complications for those with Type 1 diabetes. The aim of this study is to determine whether detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1 diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia; or continuous subcutaneous insulin infusion. Symptomatic experience and severity of hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals, response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It is envisaged that successful prevention of hypoglycaemia by one or more interventions may reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.
Detailed description
The unifying objective of the proposed unblinded randomized prospective study is to determine whether hypoglycaemia awareness in Type 1 diabetes can be restored by rigorous avoidance of hypoglycaemia addressed by one of the following interventions:
- A non-targeted approach whereby pre-prandial glycaemic targets are raised from 4.5-7mmol/L to 7.2-8.3mmol/L and hypoglycaemia is rigorously avoided without specific alterations in subcutaneous insulin regime5
- Optimisation of subcutaneous insulin regime employing pre-prandial short-acting insulin analogue in combination with once daily insulin Glargine targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
- Insulin delivery by external pump (continuous subcutaneous insulin infusion) targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 1 diabetes
- recurrent severe hypoglycemia within the preceding 6 months
- attending the Newcastle Diabetes Centre
Key exclusion criteria (4 listed)
- previous use of rapid- and long-acting insulin analogs used in an multiple daily insulin injection regimen
- previous use of continuous subcutaneous insulin infusion pump
- alcohol or drug abuse
- seizures unrelated to hypoglycemia.
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 |
|---|---|---|
| insulin glargine | Drug | – |
| continuous subcutaneous insulin infusion | Device | – |
Primary outcome
prevention of severe hypoglycemia
6 secondary outcomes
incidence of mild symptomatic hypoglycemia
HbA1C
Continuous Subcutaneous Glucose Monitoring System profiles
Altered Hypoglycemia Awareness survey
Hypoglycemia Fear Survey
Diabetes Quality Of Life of questionnaires.
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 7 Aug 2006.
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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.
James AM Shaw, MD; PhD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin glargine and continuous subcutaneous insulin infusion in people with Type 1 Diabetes Mellitus, run by Newcastle University at 1 site in United Kingdom.
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 3 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 7 Aug 2006. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
prevention of severe hypoglycemia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2006.