Type 1 DiabetesNCT02047643
Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol
A study testing Computer algorithm to initiate pump suspension in people with Type 1 Diabetes, run by Stanford University at 1 site in United States.
Trial summary
Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Computer algorithm to initiate pump suspension
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2014to 1 May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for 1-20 years. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 8 to 25 years old.
- On daily use of an insulin pump and not anticipating a change prior to the subject's completion of the study.
- Willingness to allow for CGM insertion (if not already using a study-designated CGM) for use during the study.
- HbA1c <10%.
- Parent/guardian and subject understand the study protocol and agree to comply with it.
- Informed Consent Form signed by the parent/guardian and Child Assent Form signed.
Who cannot join
- A history of recent injury to body or limb, Addison's disease, muscular disorder, organ/bone marrow transplant, heart disease, or use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- Current use of glucocorticoid medication (by any route of administration).
- Current use of a beta blocker medication.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the four weeks prior to sports camp (if a severe episode occurs after the first but prior to the scheduled second admission, the visit will be deferred).
- Active infection (if at the time of the planned second visit an infection is present, the visit will be deferred).
Trial locations and contacts
1 site in 1 country.
About this study
Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D). However, since patients with T1D often do not make exercise-related adjustments to their insulin regimen, our group has developed an algorithm to initiate pump suspension in a user-independent manner upon projecting exercise-associated hypoglycemia. The current study seeks to test the efficacy of this algorithm by asking users to participate in a sports camp while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which will communicate electronically to a pump shutoff algorithm. On one of the days the algorithm will be used, while on the other day their normal insulin rate will continue for comparative purposes.
The investigators hypothesize that the use of an accelerometer-augmented computer algorithm for insulin pump suspension during exercise will result in significantly fewer episodes of hypoglycemia (both during exercise and in post-exercise monitoring) than in exercise without a pump suspension algorithm.
Read the detailed description
Regular aerobic exercise confers a plethora of health benefits to all individuals and is considered an essential component of the management of type 1 diabetes (T1D) [1]. However, in contrast to non-diabetic subjects - in whom the increased muscle energy requirement during exercise leads to suppression of endogenous insulin secretion - patients with T1D are dependent upon exogenous insulin and are thus at risk for exercise-associated hypoglycemia [1]. Exercise-associated hypoglycemia is the most frequently reported adverse event related to exercise in diabetes [2] and hypoglycemia can occur during exercise or several hours afterwards [3,4]. Although previous research has shown that pre-meal dose reduction of subcutaneous insulin can be effective at decreasing the incidence of exercise-associated hypoglycemia [5], patients with T1D often do not perform such adjustments [6,7].
In contrast to subcutaneous insulin injections, which are reliant upon the patient or caretaker to determine dosage, the insulin pump provides a unique opportunity to avoid hypoglycemia via user-independent, computer-based algorithms for determining insulin delivery. Previous research conducted here at Stanford has demonstrated that algorithms based on continuous glucose monitor (CGM) data can prevent hypoglycemia in the sedentary setting by inducing insulin pump suspension [8-10]. In addition, a study of children and adolescents conducted at Stanford (as a center in the DirecNet group) demonstrated that suspending an insulin pump at the beginning of a period of moderate aerobic exercise reduces the risk of hypoglycemia during that exercise period and subsequently overnight [11]. Thus, by utilizing exercise-detecting accelerometers and an algorithm to initiate pump suspension during exercise, it is likely possible that people with diabetes could avoid exercise-associated hypoglycemia even if they failed to manually alter their pump settings. However, to date, no published studies have utilized accelerometer-derived data in an insulin pump suspension algorithm during exercise.
Accelerometers are light-weight motion-sensing devices that can be worn to provide information about the intensity and duration of physical activity [12]. They are small, inexpensive, and could easily be incorporated into current sensors and "patch" pumps. They can also be used independently or combined with a heart rate monitor (HRM) [13], although most commercially available HRMs currently require a chest strap that can be uncomfortable to wear. Previous studies evaluating the effect of physical activity on insulin sensitivity have utilized accelerometers (worn on a belt at the small of the back, the right side of the trunk in the mid-axillary line, or the left side of the chest) with and without HRMs for activity recognition during subjects' everyday lives. These data were used to classify activity as sedentary, light, moderate, or vigorous based on acceleration signal counts measured over one-minute intervals [13-17]. One study investigated four different accelerometers in a clinical research setting and found each to be very accurate in assessing the intensity of physical activity, regardless of subjects' body habitus [18]. Thus, these devices can provide a reliable means by which the onset, duration, and intensity of exercise can be recognized and reported in real-time to the other components of an artificial pancreas. When combined with CGM and insulin delivery data, this exercise information is a valuable tool in designing an algorithm to decrease or stop insulin delivery in order to decrease the risk of exercise-associated hypoglycemia.
In the first phase of this study (in press), 22 subjects with type 1 diabetes went about their everyday lives while wearing an insulin pump, CGM, and accelerometer/heart rate monitor. After the monitoring period, the devices were downloaded and the data were used to augment an existing predictive low glucose suspend (PLGS) algorithm to incorporate activity. In a computer simulator, the PLGS algorithm reduced hypoglycemia by 64%, compared to 73% and 76% reductions for the accelerometer-augmented and HRM-augmented algorithms, respectively.
In the next phase of this study, we seek to test the newly developed algorithm in a real-life setting in the form of a structured sports (soccer) camp to further see if modifications to the algorithm are required.
- Conditions
- Type 1 Diabetes
- Being tested
- Computer algorithm to initiate pump suspension
- Keywords
- Type 1 diabetes, Hypoglycemia, Accelerometer
- 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.
Computer algorithm to initiate pump suspensionDevice
Also called Augmented predictive low glucose suspend algorithm
If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump
| Study group | Role | What they receive |
|---|---|---|
| On-algorithm first, then Off-algorithm | Experimental | Users will participate in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm is turned on; on the other day, the algorithm is turned off. Receives: Device: Computer algorithm to initiate pump suspension |
| Off-algorithm first, then On-algorithm | Experimental | Users will participate in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm is turned on; on the other day, the algorithm is turned off. Receives: Device: Computer algorithm to initiate pump suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise
The primary outcome will be a hypoglycemic event defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia
Measured: Measurements occurring during exercise (up to 8 hours)
Secondary outcomes (1)
Count of Participants With Hypoglycemia in the Post Exercise Period
A hypoglycemic event was defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia
Measured: In the time following exercise until the following morning (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study start12 Mar 2014
- Primary completion1 May 2014
- Study completion1 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Model description
- randomized crossover design. Subjects with type 1 diabetes participated in a structured soccer session on two separate dates at least one week apart. During one session a subject's basal insulin rate was continued ("off-algorithm"), while during the other session the algorithm (see "algorithm monitoring" below) was in effect ("on-algorithm"); the order of on- versus off-algorithm was chosen at random. The rate of hypoglycemia during exercise were compared between each group. Hypoglycemia was defined as (1) any meter blood glu cose (BG) reading of =60 mg/dl, (2) two consecutive meter BG readings =70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia (regardless of corre sponding meter BG reading).
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Buckingham, Stanford University
- Investigators
- Bruce A Buckingham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047643
- Sponsor's protocol ID
- 29205
- Status last verified
- Dec 2019
- First submitted
- 17 Jan 2014
- Last updated
- 27 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
American Diabetes Association. Physical activity/exercise and diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S58-62. doi: 10.2337/diacare.27.2007.s58. No abstract available.
PubMed 14693927Sonnenberg GE, Kemmer FW, Berger M. Exercise in type 1 (insulin-dependent) diabetic patients treated with continuous subcutaneous insulin infusion. Prevention of exercise induced hypoglycaemia. Diabetologia. 1990 Nov;33(11):696-703. doi: 10.1007/BF00400572.
PubMed 2076801MacDonald MJ. Postexercise late-onset hypoglycemia in insulin-dependent diabetic patients. Diabetes Care. 1987 Sep-Oct;10(5):584-8. doi: 10.2337/diacare.10.5.584.
PubMed 3677976Tuominen JA, Karonen SL, Melamies L, Bolli G, Koivisto VA. Exercise-induced hypoglycaemia in IDDM patients treated with a short-acting insulin analogue. Diabetologia. 1995 Jan;38(1):106-11. doi: 10.1007/BF02369359.
PubMed 7744214Rabasa-Lhoret R, Bourque J, Ducros F, Chiasson JL. Guidelines for premeal insulin dose reduction for postprandial exercise of different intensities and durations in type 1 diabetic subjects treated intensively with a basal-bolus insulin regimen (ultralente-lispro). Diabetes Care. 2001 Apr;24(4):625-30. doi: 10.2337/diacare.24.4.625.
PubMed 11315820Bernardini AL, Vanelli M, Chiari G, Iovane B, Gelmetti C, Vitale R, Errico MK. Adherence to physical activity in young people with type 1 diabetes. Acta Biomed. 2004 Dec;75(3):153-7.
PubMed 15796088Devadoss M, Kennedy L, Herbold N. Endurance athletes and type 1 diabetes. Diabetes Educ. 2011 Mar-Apr;37(2):193-207. doi: 10.1177/0145721710395782. Epub 2011 Feb 15.
PubMed 21325065Buckingham B, Cobry E, Clinton P, Gage V, Caswell K, Kunselman E, Cameron F, Chase HP. Preventing hypoglycemia using predictive alarm algorithms and insulin pump suspension. Diabetes Technol Ther. 2009 Feb;11(2):93-7. doi: 10.1089/dia.2008.0032.
PubMed 19848575Cengiz E, Swan KL, Tamborlane WV, Steil GM, Steffen AT, Weinzimer SA. Is an automatic pump suspension feature safe for children with type 1 diabetes? An exploratory analysis with a closed-loop system. Diabetes Technol Ther. 2009 Apr;11(4):207-10. doi: 10.1089/dia.2008.0102.
PubMed 19344194Buckingham B, Chase HP, Dassau E, Cobry E, Clinton P, Gage V, Caswell K, Wilkinson J, Cameron F, Lee H, Bequette BW, Doyle FJ 3rd. Prevention of nocturnal hypoglycemia using predictive alarm algorithms and insulin pump suspension. Diabetes Care. 2010 May;33(5):1013-7. doi: 10.2337/dc09-2303. Epub 2010 Mar 3.
PubMed 20200307Diabetes Research in Children Network (DirecNet) Study Group; Tsalikian E, Kollman C, Tamborlane WB, Beck RW, Fiallo-Scharer R, Fox L, Janz KF, Ruedy KJ, Wilson D, Xing D, Weinzimer SA. Prevention of hypoglycemia during exercise in children with type 1 diabetes by suspending basal insulin. Diabetes Care. 2006 Oct;29(10):2200-4. doi: 10.2337/dc06-0495.
PubMed 17003293Plasqui G, Westerterp KR. Physical activity assessment with accelerometers: an evaluation against doubly labeled water. Obesity (Silver Spring). 2007 Oct;15(10):2371-9. doi: 10.1038/oby.2007.281.
PubMed 17925461Gradmark A, Pomeroy J, Renstrom F, Steiginga S, Persson M, Wright A, Bluck L, Domellof M, Kahn SE, Mogren I, Franks PW. Physical activity, sedentary behaviors, and estimated insulin sensitivity and secretion in pregnant and non-pregnant women. BMC Pregnancy Childbirth. 2011 Jun 16;11:44. doi: 10.1186/1471-2393-11-44.
PubMed 21679399Balkau B, Mhamdi L, Oppert JM, Nolan J, Golay A, Porcellati F, Laakso M, Ferrannini E; EGIR-RISC Study Group. Physical activity and insulin sensitivity: the RISC study. Diabetes. 2008 Oct;57(10):2613-8. doi: 10.2337/db07-1605. Epub 2008 Jun 30.
PubMed 18591396Ekelund U, Griffin SJ, Wareham NJ. Physical activity and metabolic risk in individuals with a family history of type 2 diabetes. Diabetes Care. 2007 Feb;30(2):337-42. doi: 10.2337/dc06-1883.
PubMed 17259504
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol
- ClinicalTrials.gov ID
- NCT02047643
- Acronym / sponsor ID
- 29205
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Hypoglycemia, Accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Mar 2014 (actual)
- Primary completion
- 1 May 2014 (actual)
- Study completion
- 1 May 2014 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D). However, since patients with T1D often do not make exercise-related adjustments to their insulin regimen, our group has developed an algorithm to initiate pump suspension in a user-independent manner upon projecting exercise-associated hypoglycemia. The current study seeks to test the efficacy of this algorithm by asking users to participate in a sports camp while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which will communicate electronically to a pump shutoff algorithm. On one of the days the algorithm will be used, while on the other day their normal insulin rate will continue for comparative purposes.
The investigators hypothesize that the use of an accelerometer-augmented computer algorithm for insulin pump suspension during exercise will result in significantly fewer episodes of hypoglycemia (both during exercise and in post-exercise monitoring) than in exercise without a pump suspension algorithm.
Detailed description
Regular aerobic exercise confers a plethora of health benefits to all individuals and is considered an essential component of the management of type 1 diabetes (T1D) [1]. However, in contrast to non-diabetic subjects - in whom the increased muscle energy requirement during exercise leads to suppression of endogenous insulin secretion - patients with T1D are dependent upon exogenous insulin and are thus at risk for exercise-associated hypoglycemia [1]. Exercise-associated hypoglycemia is the most frequently reported adverse event related to exercise in diabetes [2] and hypoglycemia can occur during exercise or several hours afterwards [3,4]. Although previous research has shown that pre-meal dose reduction of subcutaneous insulin can be effective at decreasing the incidence of exercise-associated hypoglycemia [5], patients with T1D often do not perform such adjustments [6,7].
In contrast to subcutaneous insulin injections, which are reliant upon the patient or caretaker to determine dosage, the insulin pump provides a unique opportunity to avoid hypoglycemia via user-independent, computer-based algorithms for determining insulin delivery. Previous research conducted here at Stanford has demonstrated that algorithms based on continuous glucose monitor (CGM) data can prevent hypoglycemia in the sedentary setting by inducing insulin pump suspension [8-10]. In addition, a study of children and adolescents conducted at Stanford (as a center in the DirecNet group) demonstrated that suspending an insulin pump at the beginning of a period of moderate aerobic exercise reduces the risk of hypoglycemia during that exercise period and subsequently overnight [11]. Thus, by utilizing exercise-detecting accelerometers and an algorithm to initiate pump suspension during exercise, it is likely possible that people with diabetes could avoid exercise-associated hypoglycemia even if they failed to manually alter their pump settings. However, to date, no published studies have utilized accelerometer-derived data in an insulin pump suspension algorithm during exercise.
Accelerometers are light-weight motion-sensing devices that can be worn to provide information about the intensity and duration of physical activity [12]. They are small, inexpensive, and could easily be incorporated into current sensors and "patch" pumps. They can also be used independently or combined with a heart rate monitor (HRM) [13], although most commercially available HRMs currently require a chest strap that can be uncomfortable to wear. Previous studies evaluating the effect of physical activity on insulin sensitivity have utilized accelerometers (worn on a belt at the small of the back, the right side of the trunk in the mid-axillary line, or the left side of the chest) with and without HRMs for activity recognition during subjects' everyday lives. These data were used to classify activity as sedentary, light, moderate, or vigorous based on acceleration signal counts measured over one-minute intervals [13-17]. One study investigated four different accelerometers in a clinical research setting and found each to be very accurate in assessing the intensity of physical activity, regardless of subjects' body habitus [18]. Thus, these devices can provide a reliable means by which the onset, duration, and intensity of exercise can be recognized and reported in real-time to the other components of an artificial pancreas. When combined with CGM and insulin delivery data, this exercise information is a valuable tool in designing an algorithm to decrease or stop insulin delivery in order to decrease the risk of exercise-associated hypoglycemia.
In the first phase of this study (in press), 22 subjects with type 1 diabetes went about their everyday lives while wearing an insulin pump, CGM, and accelerometer/heart rate monitor. After the monitoring period, the devices were downloaded and the data were used to augment an existing predictive low glucose suspend (PLGS) algorithm to incorporate activity. In a computer simulator, the PLGS algorithm reduced hypoglycemia by 64%, compared to 73% and 76% reductions for the accelerometer-augmented and HRM-augmented algorithms, respectively.
In the next phase of this study, we seek to test the newly developed algorithm in a real-life setting in the form of a structured sports (soccer) camp to further see if modifications to the algorithm are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized crossover design. Subjects with type 1 diabetes participated in a structured soccer session on two separate dates at least one week apart. During one session a subject's basal insulin rate was continued ("off-algorithm"), while during the other session the algorithm (see "algorithm monitoring" below) was in effect ("on-algorithm"); the order of on- versus off-algorithm was chosen at random. The rate of hypoglycemia during exercise were compared between each group. Hypoglycemia was defined as (1) any meter blood glu cose (BG) reading of =60 mg/dl, (2) two consecutive meter BG readings =70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia (regardless of corre sponding meter BG reading).
| Arm | Type | Receives |
|---|---|---|
| On-algorithm first, then Off-algorithm | Experimental | Device: Computer algorithm to initiate pump suspensionUsers will participate in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm is turned on; on the other day, the algorithm is turned off. |
| Off-algorithm first, then On-algorithm | Experimental | Device: Computer algorithm to initiate pump suspensionUsers will participate in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm is turned on; on the other day, the algorithm is turned off. |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of type 1 diabetes for 1-20 years. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 8 to 25 years old.
- On daily use of an insulin pump and not anticipating a change prior to the subject's completion of the study.
- Willingness to allow for CGM insertion (if not already using a study-designated CGM) for use during the study.
- HbA1c <10%.
Key exclusion criteria (5 listed)
- A history of recent injury to body or limb, Addison's disease, muscular disorder, organ/bone marrow transplant, heart disease, or use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- Current use of glucocorticoid medication (by any route of administration).
- Current use of a beta blocker medication.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the four weeks prior to sports camp (if a severe episode occurs after the first but prior to the scheduled second admission, the visit will be deferred).
- Active infection (if at the time of the planned second visit an infection is present, the visit will be deferred).
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 |
|---|---|---|
| Computer algorithm to initiate pump suspensionAlso: Augmented predictive low glucose suspend algorithmIf the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump | Device | Off-algorithm first, then On-algorithm, On-algorithm first, then Off-algorithm |
Primary outcome
Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise
Time frame: Measurements occurring during exercise (up to 8 hours)
The primary outcome will be a hypoglycemic event defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia
1 secondary outcome
Count of Participants With Hypoglycemia in the Post Exercise Period
Time frame: In the time following exercise until the following morning (up to 24 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14693927American Diabetes Association. Physical activity/exercise and diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S58-62. doi: 10.2337/diacare.27.2007.s58. No abstract available.
- Background: PubMed 2076801Sonnenberg GE, Kemmer FW, Berger M. Exercise in type 1 (insulin-dependent) diabetic patients treated with continuous subcutaneous insulin infusion. Prevention of exercise induced hypoglycaemia. Diabetologia. 1990 Nov;33(11):696-703. doi: 10.1007/BF00400572.
- Background: PubMed 3677976MacDonald MJ. Postexercise late-onset hypoglycemia in insulin-dependent diabetic patients. Diabetes Care. 1987 Sep-Oct;10(5):584-8. doi: 10.2337/diacare.10.5.584.
- Background: PubMed 7744214Tuominen JA, Karonen SL, Melamies L, Bolli G, Koivisto VA. Exercise-induced hypoglycaemia in IDDM patients treated with a short-acting insulin analogue. Diabetologia. 1995 Jan;38(1):106-11. doi: 10.1007/BF02369359.
- Background: PubMed 11315820Rabasa-Lhoret R, Bourque J, Ducros F, Chiasson JL. Guidelines for premeal insulin dose reduction for postprandial exercise of different intensities and durations in type 1 diabetic subjects treated intensively with a basal-bolus insulin regimen (ultralente-lispro). Diabetes Care. 2001 Apr;24(4):625-30. doi: 10.2337/diacare.24.4.625.
- Background: PubMed 15796088Bernardini AL, Vanelli M, Chiari G, Iovane B, Gelmetti C, Vitale R, Errico MK. Adherence to physical activity in young people with type 1 diabetes. Acta Biomed. 2004 Dec;75(3):153-7.
- Background: PubMed 21325065Devadoss M, Kennedy L, Herbold N. Endurance athletes and type 1 diabetes. Diabetes Educ. 2011 Mar-Apr;37(2):193-207. doi: 10.1177/0145721710395782. Epub 2011 Feb 15.
- Background: PubMed 19848575Buckingham B, Cobry E, Clinton P, Gage V, Caswell K, Kunselman E, Cameron F, Chase HP. Preventing hypoglycemia using predictive alarm algorithms and insulin pump suspension. Diabetes Technol Ther. 2009 Feb;11(2):93-7. doi: 10.1089/dia.2008.0032.
- Background: PubMed 19344194Cengiz E, Swan KL, Tamborlane WV, Steil GM, Steffen AT, Weinzimer SA. Is an automatic pump suspension feature safe for children with type 1 diabetes? An exploratory analysis with a closed-loop system. Diabetes Technol Ther. 2009 Apr;11(4):207-10. doi: 10.1089/dia.2008.0102.
- Background: PubMed 20200307Buckingham B, Chase HP, Dassau E, Cobry E, Clinton P, Gage V, Caswell K, Wilkinson J, Cameron F, Lee H, Bequette BW, Doyle FJ 3rd. Prevention of nocturnal hypoglycemia using predictive alarm algorithms and insulin pump suspension. Diabetes Care. 2010 May;33(5):1013-7. doi: 10.2337/dc09-2303. Epub 2010 Mar 3.
- Background: PubMed 17003293Diabetes Research in Children Network (DirecNet) Study Group; Tsalikian E, Kollman C, Tamborlane WB, Beck RW, Fiallo-Scharer R, Fox L, Janz KF, Ruedy KJ, Wilson D, Xing D, Weinzimer SA. Prevention of hypoglycemia during exercise in children with type 1 diabetes by suspending basal insulin. Diabetes Care. 2006 Oct;29(10):2200-4. doi: 10.2337/dc06-0495.
- Background: PubMed 17925461Plasqui G, Westerterp KR. Physical activity assessment with accelerometers: an evaluation against doubly labeled water. Obesity (Silver Spring). 2007 Oct;15(10):2371-9. doi: 10.1038/oby.2007.281.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Bruce A Buckingham, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer algorithm to initiate pump suspension in people with Type 1 Diabetes, run by Stanford University at 1 site in United States.
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 7 inclusion and 5 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 Dec 2019. 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 States. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise (time frame: Measurements occurring during exercise (up to 8 hours)). 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 NCT02047643, which also lists 19 linked publications.
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 Dec 2019.