Type 1 Diabetes MellitusNCT01401127
Managing Insulin Pumps for Exercise - Study 1
An observational study of Type 1 Diabetes Mellitus, 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Aug 2011
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with Type 1 Diabetes treated with insulin pump therapy who exercise for at least 1 hour each week and comparable participants without diabetes mellitus
Who may be able to join
- For participants with Type 1 Diabetes Mellitus
- 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
Show all 10Show fewer
- For participants without Type 1 Diabetes Mellitus
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged between 18 and 65 years
- Exercises regularly for more than 1 hour per week
Who cannot join
- For participants with type 1 Diabetes Mellitus
- 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
Show all 16Show fewer
- peripheral vascular disease
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
- Treatment with drugs known to interfere with glucose metabolism
- For participants without Type 1 Diabetes Mellitus
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Diagnosis of impaired fasting glucose, impaired glucose tolerance or diabetes mellitus
- 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: A Comparison of Metabolism During Moderate Exercise Between Healthy Volunteers and People With T1DM Treated With CSII Using 70% of Their Usual Insulin Basal Rate
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. This first part of the research is designed to compare metabolic response to exercise between people without diabetes and people with T1DM running there insulin pump at the usual basal rate.
Read the detailed description
For the first part of the study, participants will be either people with type 1 diabetes treated with insulin pump therapy or volunteers without diabetes. The 2 groups will be matched as far as possible by age, body mass index and usual level of activity. Participants will attend an exercise laboratory on 2 occasions. On the first occasion, which can take place at any time of day, formal written consent will be obtained for participation in the study. Participants will then undergo measurement of maximal exercise capacity (VO2 MAX). On the second occasion they will attend 2 hours after a lunch containing 60 grams of carbohydrate (advice will be given on how this can be achieved). A cannula will be inserted on arrival and blood samples obtained. Arterialised samples will be obtained by using a heated hand technique. Once the cannula has been inserted participants with type 1 diabetes will be asked to reduce the basal insulin infusion rate on their insulin pump to 70% of normal until the end of the study visit. After 30 minutes a further set of blood samples will be obtained, and participants will then start to exercise for 1 hour at 50% VO2 MAX. A further set of blood samples will be obtained at the end of the hour of exercise. Participants will then rest for 30 minutes before a final set of blood samples is taken. At this point the cannula will be removed and the study visit ends. Participants with diabetes will be given the choice to return basal insulin infusion rate to normal at this point. A snack will be offered.
Blood glucose will be monitored every 10 minutes and also if a participant feels symptoms of hypoglycaemia. If hypoglycaemia occurs the protocol will be stopped and carbohydrate given until the blood glucose level returns to the normal range.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Exercise, Continuous Subcutaneous Insulin Infusion, CSII, Insulin Pump Therapy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | Participants with type 1 Diabetes running their insulin pump at 70% of usual basal rate | |
| Participants without diabetes | Participants without diabetes or evidence of impaired glucose regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose excursion
The primary outcome measure is change in blood glucose (glucose excursion) between the start and the end of exercise
Measured: Glucose will be measured at the start and end of 1 hour of exercise at 50% VO2 MAX during the second study visit
Secondary outcomes (10)
Comparison between the two groups of levels of lactate
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Multiple correlation between blood glucose values and values of lactate, NEFA, betahydroxybutyrate, catecholamines, glucagon, insulin, C-peptide, human growth hormone and cortisol
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Ratio of respiratory quotient (RQ) at the beginning of exercise to RQ at the end of exercise, compared between the two groups, which will give information about fuel use during exercise.
Measured: Respiratory quotient will be calculated using a breath by breath analyser using 2 minutes of data from the start at the end of exercise
Comparison between the two groups of levels of non-esterified fatty acids (NEFA)
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of beta-hydroxybutyrate
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of circulating catecholamines
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of glucagon
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of circulating insulin
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of human growth hormone
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of cortisol
Measured: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Animas Corporation
- Responsible party
- Sponsor
- Investigators
- Ian W Gallen, MD FRCP, Principal investigator, Buckinghamshire Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401127
- Sponsor's protocol ID
- RXQ404(1)
- Status last verified
- Nov 2011
- First submitted
- 20 Jul 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Metabolism During Moderate Exercise Between Healthy Volunteers and People With T1DM Treated With CSII Using 70% of Their Usual Insulin Basal Rate
- ClinicalTrials.gov ID
- NCT01401127
- Acronym / sponsor ID
- RXQ404(1)
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Exercise, Continuous Subcutaneous Insulin Infusion, CSII, Insulin Pump Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Buckinghamshire Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Animas Corporation
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 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. This first part of the research is designed to compare metabolic response to exercise between people without diabetes and people with T1DM running there insulin pump at the usual basal rate.
Detailed description
For the first part of the study, participants will be either people with type 1 diabetes treated with insulin pump therapy or volunteers without diabetes. The 2 groups will be matched as far as possible by age, body mass index and usual level of activity. Participants will attend an exercise laboratory on 2 occasions. On the first occasion, which can take place at any time of day, formal written consent will be obtained for participation in the study. Participants will then undergo measurement of maximal exercise capacity (VO2 MAX). On the second occasion they will attend 2 hours after a lunch containing 60 grams of carbohydrate (advice will be given on how this can be achieved). A cannula will be inserted on arrival and blood samples obtained. Arterialised samples will be obtained by using a heated hand technique. Once the cannula has been inserted participants with type 1 diabetes will be asked to reduce the basal insulin infusion rate on their insulin pump to 70% of normal until the end of the study visit. After 30 minutes a further set of blood samples will be obtained, and participants will then start to exercise for 1 hour at 50% VO2 MAX. A further set of blood samples will be obtained at the end of the hour of exercise. Participants will then rest for 30 minutes before a final set of blood samples is taken. At this point the cannula will be removed and the study visit ends. Participants with diabetes will be given the choice to return basal insulin infusion rate to normal at this point. A snack will be offered.
Blood glucose will be monitored every 10 minutes and also if a participant feels symptoms of hypoglycaemia. If hypoglycaemia occurs the protocol will be stopped and carbohydrate given until the blood glucose level returns to the normal range.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | – | –Participants with type 1 Diabetes running their insulin pump at 70% of usual basal rate |
| Participants without diabetes | – | –Participants without diabetes or evidence of impaired glucose regulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Type 1 Diabetes treated with insulin pump therapy who exercise for at least 1 hour each week and comparable participants without diabetes mellitus
Key inclusion criteria (10 listed)
- For participants with Type 1 Diabetes Mellitus
- 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
Key exclusion criteria (16 listed)
- For participants with type 1 Diabetes Mellitus
- People with any one of the following complications of diabetes:
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose excursion
Time frame: Glucose will be measured at the start and end of 1 hour of exercise at 50% VO2 MAX during the second study visit
The primary outcome measure is change in blood glucose (glucose excursion) between the start and the end of exercise
10 secondary outcomes
Comparison between the two groups of levels of lactate
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Multiple correlation between blood glucose values and values of lactate, NEFA, betahydroxybutyrate, catecholamines, glucagon, insulin, C-peptide, human growth hormone and cortisol
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Ratio of respiratory quotient (RQ) at the beginning of exercise to RQ at the end of exercise, compared between the two groups, which will give information about fuel use during exercise.
Time frame: Respiratory quotient will be calculated using a breath by breath analyser using 2 minutes of data from the start at the end of exercise
Comparison between the two groups of levels of non-esterified fatty acids (NEFA)
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of beta-hydroxybutyrate
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of circulating catecholamines
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of glucagon
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of circulating insulin
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of human growth hormone
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of cortisol
Time frame: Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
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 8 Nov 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?
An observational study of Type 1 Diabetes Mellitus, 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 10 inclusion and 16 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 8 Nov 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 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?
Glucose excursion (time frame: Glucose will be measured at the start and end of 1 hour of exercise at 50% VO2 MAX during the second study visit). 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 8 Nov 2011.