Type 1 DiabetesNCT01398995
Managing Insulin Pumps for Exercise (Study 2)
A study testing Reduction of basal insulin infusion to 50% of normal in people with Type 1 Diabetes, run by Buckinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but problems with metabolism and blood glucose control can make this difficult. Some people with T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous insulin infusion (CSII) therapy, in which a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Reduction of basal insulin infusion to 50% of normal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Sep 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 65 years
- Diagnosed with Type 1 diabetes mellitus
- Treated with CSII for at least 3 months
- Exercises regularly for more than 1 hour per week
Who cannot join
- People with any one of the following complications of diabetes:
- stage 2+ diabetic retinopathy
- renal impairment (with creatinine >150micromol/l)
- known history or symptoms of cardiovascular disease
- foot ulceration
- peripheral vascular disease
Show all 10Show fewer
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
- Treatment with drugs known to interfere with glucose metabolism
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wycombe Hospital
High Wycombe, Buckinghamshire, HP11 2TT
About this study
Official title: To Consider the Effect of the Timing of a Reduction in Basal Insulin Infusion Rate to 50% of Normal Prior to Exercise on Glycaemic Control in People With Type 1 Diabetes Treated With CSII
People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but problems with metabolism and blood glucose control can make this difficult. Some people with T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous insulin infusion (CSII) therapy, in which a background or basal level of insulin is constantly infused under the skin by a special pump, with bolus doses of insulin given to accompany food. Clinical experience suggests that this may be particularly useful for managing diabetes for exercise, but there is limited experimental evidence to support this. The aim of this research , which is divided into three parts, is to investigate the hypothesis that the physiological response to sub-maximal (moderate) exercise of a person with type 1 diabetes treated with CSII, can be made to approximate more closely to the physiological response of a healthy individual by a prior reduction of their basal insulin infusion rate. Evidence from children demonstrates that reducing the basal insulin infusion rate to 50% of normal at the beginning of exercise can reduce rates of low blood glucose (hypoglycaemia) during exercise. However, reducing the insulin infusion rate will not have an immediate effect on levels of insulin in the body, and evidence from adults suggests that the level of insulin in the bloodstream at the start of exercise is an important factor in whether hypoglycaemia develops during exercise. This suggests that reducing the basal insulin infusion rate some time before exercise may be useful. The aim of this study is to compare the effect of a basal insulin reduction on blood glucose levels between visits when this reduction is made at the start of exercise, 30 minutes before, 60 minutes before and 90 minutes before. The null hypothesis to be tested is that there is no difference between these conditions.
Read the detailed description
Participants recruited will have type 1 diabetes treated with CSII. Each participant will be required to attend on 5 separate occasions. The first visit can take place at any time of day. At this first visit formal, written consent will be obtained for participation in the trial. Following this an assessment will be made of VO2 MAX(maximal oxygen uptake during exercise) using the Balke-Ware treadmill protocol. Once this is finished the first visit will be completed.
The other 4 visits will all take place 2 hours following a lunch containing 60 grams of carbohydrate. Advice will be given about how this can be achieved. On arrival a cannula will be inserted in the dorsum of a hand and blood samples taken. The hand will be armed to allow the taking of arterialised blood samples. Further blood samples will be taken after 30, 60 and 90 minutes and then exercise will commence. Participants will be asked to reduce their basal insulin infusion rate to 50% of usual either immediately after the cannula has been inserted or 30 minutes later (1 hour prior to exercise), 60 minutes later (30 minutes prior to exercise) or 90 minutes later (at the start of exercise). These four conditions will be presented to each participant in a randomised order. Participants will exercise for 60 minutes at 50% VO2 MAX on an electronically braked cycle ergometer. At the end of exercise a set of blood samples will be taken. Participants will then rest for 30 minutes and a final set of blood samples will be taken. After this the cannula will be removed and the study visit will be complete. A snack will be offered.
In the event of hypoglycaemia identified on point of care testing a blood sample will be taken for laboratory confirmation. Participants will be given 15 grams of carbohydrate but permitted to continue exercising unless they feel that the exercise has become significantly more difficult, they feel unwell or the investigator has any concerns. Participants will be given 15 grams of rapid acting carbohydrate, repeated every 10-15 minutes until blood glucose levels rise above 4mmol/l.
- Conditions
- Type 1 Diabetes
- Being tested
- Reduction of basal insulin infusion to 50% of normal
- Keywords
- Type 1 Diabetes, Exercise, continuous subcutaneous insulin infusion
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of basal insulin infusion to 50% of normalOther
Each participant in this cross-over trial will participate in the 4 arms of the trial. They will be presented with the four conditions in randomised order - reducing their basal insulin infusion rate to 50% of normal at the four time points specified. A comparison will be made between the conditions.
| Study group | Role | What they receive |
|---|---|---|
| 90 minutes | Experimental | Basal insulin infusion reduced to 50% of normal 90 minutes prior to exercise Receives: Other: Reduction of basal insulin infusion to 50% of normal |
| 60 minutes | Experimental | Basal insulin infusion reduced to 50% of normal 60 minutes prior to exercise Receives: Other: Reduction of basal insulin infusion to 50% of normal |
| 30 minutes | Experimental | Basal insulin infusion reduced to normal 30 minutes prior to exercise Receives: Other: Reduction of basal insulin infusion to 50% of normal |
| Start | Experimental | Basal insulin infusion reduced to 50% of normal at the start of exercise Receives: Other: Reduction of basal insulin infusion to 50% of normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of glucose excursion (change in blood glucose) between baseline and the end of exercise between the four conditions.
Measured: Samples taken on arrival and at the end of exercise
Secondary outcomes (4)
Comparison between the four conditions of change in blood glucose levels between baseline and the beginning of exercise, and between the beginning and end of exercise.
Measured: Samples taken at baseline, beginning and end of exercise
Levels of NEFA and lactate will be compared between the four conditions
Samples will be taken in each condition at baseline (90 minutes prior to exercise), after 30 minutes (60 minutes prior to exercise), after 60 minutes (30 minutes prior to exercise), after 90 minutes (at the start of exercise), after 150 minutes (at the end of 1 hour of exercise) and at 180 minutes (30 minutes after the end of exercise)
Measured: Samples will be taken at the 6 time points detailed below
Correlation between levels of NEFA and lactate and blood glucose will be considered.
Samples will be taken in each condition at baseline (90 minutes prior to exercise), after 30 minutes (60 minutes prior to exercise), after 60 minutes (30 minutes prior to exercise), after 90 minutes (at the start of exercise), after 150 minutes (at the end of 1 hour of exercise) and at 180 minutes (30 minutes after the end of exercise)
Measured: Samples will be taken at the time points detailed below
Ratio of respiratory quotient (RQ) at the beginning of exercise to RQ at the end of exercise compared between the four conditions.
Measured: Breath by breath data will be recorded for 2 minutes at the start and the end of the exercise period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Recruitment was terminated due to elevated levels of hypoglycaemia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Animas Corporation
- Investigators
- Ian W Gallen, MD FRCP, Principal investigator, Buckinghamshire Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398995
- Sponsor's protocol ID
- RXQ404
- Status last verified
- Jul 2011
- First submitted
- 20 Jul 2011
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Consider the Effect of the Timing of a Reduction in Basal Insulin Infusion Rate to 50% of Normal Prior to Exercise on Glycaemic Control in People With Type 1 Diabetes Treated With CSII
- ClinicalTrials.gov ID
- NCT01398995
- Acronym / sponsor ID
- RXQ404
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Exercise, continuous subcutaneous insulin infusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was terminated due to elevated levels of hypoglycaemia
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Buckinghamshire Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Animas Corporation
- Study start
- May 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 21 Jul 2011 (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.
People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but problems with metabolism and blood glucose control can make this difficult. Some people with T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous insulin infusion (CSII) therapy, in which a background or basal level of insulin is constantly infused under the skin by a special pump, with bolus doses of insulin given to accompany food. Clinical experience suggests that this may be particularly useful for managing diabetes for exercise, but there is limited experimental evidence to support this. The aim of this research , which is divided into three parts, is to investigate the hypothesis that the physiological response to sub-maximal (moderate) exercise of a person with type 1 diabetes treated with CSII, can be made to approximate more closely to the physiological response of a healthy individual by a prior reduction of their basal insulin infusion rate. Evidence from children demonstrates that reducing the basal insulin infusion rate to 50% of normal at the beginning of exercise can reduce rates of low blood glucose (hypoglycaemia) during exercise. However, reducing the insulin infusion rate will not have an immediate effect on levels of insulin in the body, and evidence from adults suggests that the level of insulin in the bloodstream at the start of exercise is an important factor in whether hypoglycaemia develops during exercise. This suggests that reducing the basal insulin infusion rate some time before exercise may be useful. The aim of this study is to compare the effect of a basal insulin reduction on blood glucose levels between visits when this reduction is made at the start of exercise, 30 minutes before, 60 minutes before and 90 minutes before. The null hypothesis to be tested is that there is no difference between these conditions.
Detailed description
Participants recruited will have type 1 diabetes treated with CSII. Each participant will be required to attend on 5 separate occasions. The first visit can take place at any time of day. At this first visit formal, written consent will be obtained for participation in the trial. Following this an assessment will be made of VO2 MAX(maximal oxygen uptake during exercise) using the Balke-Ware treadmill protocol. Once this is finished the first visit will be completed.
The other 4 visits will all take place 2 hours following a lunch containing 60 grams of carbohydrate. Advice will be given about how this can be achieved. On arrival a cannula will be inserted in the dorsum of a hand and blood samples taken. The hand will be armed to allow the taking of arterialised blood samples. Further blood samples will be taken after 30, 60 and 90 minutes and then exercise will commence. Participants will be asked to reduce their basal insulin infusion rate to 50% of usual either immediately after the cannula has been inserted or 30 minutes later (1 hour prior to exercise), 60 minutes later (30 minutes prior to exercise) or 90 minutes later (at the start of exercise). These four conditions will be presented to each participant in a randomised order. Participants will exercise for 60 minutes at 50% VO2 MAX on an electronically braked cycle ergometer. At the end of exercise a set of blood samples will be taken. Participants will then rest for 30 minutes and a final set of blood samples will be taken. After this the cannula will be removed and the study visit will be complete. A snack will be offered.
In the event of hypoglycaemia identified on point of care testing a blood sample will be taken for laboratory confirmation. Participants will be given 15 grams of carbohydrate but permitted to continue exercising unless they feel that the exercise has become significantly more difficult, they feel unwell or the investigator has any concerns. Participants will be given 15 grams of rapid acting carbohydrate, repeated every 10-15 minutes until blood glucose levels rise above 4mmol/l.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 90 minutes | Experimental | Other: Reduction of basal insulin infusion to 50% of normalBasal insulin infusion reduced to 50% of normal 90 minutes prior to exercise |
| 60 minutes | Experimental | Other: Reduction of basal insulin infusion to 50% of normalBasal insulin infusion reduced to 50% of normal 60 minutes prior to exercise |
| 30 minutes | Experimental | Other: Reduction of basal insulin infusion to 50% of normalBasal insulin infusion reduced to normal 30 minutes prior to exercise |
| Start | Experimental | Other: Reduction of basal insulin infusion to 50% of normalBasal insulin infusion reduced to 50% of normal at the start of exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 65 years
- Diagnosed with Type 1 diabetes mellitus
- Treated with CSII for at least 3 months
- Exercises regularly for more than 1 hour per week
Key exclusion criteria (10 listed)
- People with any one of the following complications of diabetes:
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
- Treatment with drugs known to interfere with glucose metabolism
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 |
|---|---|---|
| Reduction of basal insulin infusion to 50% of normalEach participant in this cross-over trial will participate in the 4 arms of the trial. They will be presented with the four conditions in randomised order - reducing their basal insulin infusion rate to 50% of normal at the four time points specified. A comparison will be made between the conditions. | Other | 30 minutes, 60 minutes, 90 minutes, Start |
Primary outcome
Comparison of glucose excursion (change in blood glucose) between baseline and the end of exercise between the four conditions.
Time frame: Samples taken on arrival and at the end of exercise
4 secondary outcomes
Comparison between the four conditions of change in blood glucose levels between baseline and the beginning of exercise, and between the beginning and end of exercise.
Time frame: Samples taken at baseline, beginning and end of exercise
Levels of NEFA and lactate will be compared between the four conditions
Time frame: Samples will be taken at the 6 time points detailed below
Correlation between levels of NEFA and lactate and blood glucose will be considered.
Time frame: Samples will be taken at the time points detailed below
Ratio of respiratory quotient (RQ) at the beginning of exercise to RQ at the end of exercise compared between the four conditions.
Time frame: Breath by breath data will be recorded for 2 minutes at the start and the end of the exercise period
Results and safety
The study was stopped early (reason given: Recruitment was terminated due to elevated levels of hypoglycaemia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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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.
Ian W Gallen, MD FRCP principal investigator
Buckinghamshire Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction of basal insulin infusion to 50% of normal in people with Type 1 Diabetes, run by Buckinghamshire Healthcare NHS Trust 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 21 Jul 2011. 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment was terminated due to elevated levels of hypoglycaemia). Results are not available in the source record.
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?
Comparison of glucose excursion (change in blood glucose) between baseline and the end of exercise between the four conditions. (time frame: Samples taken on arrival and at the end of exercise). 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 21 Jul 2011.