Type1 Diabetes MellitusPhase 4BIG LEAPNCT04409587
Basal Insulin Glycemic ControL With DEglugec vs Aspart Via Pump
A Phase 4 study testing Aspart in people with Type1 Diabetes Mellitus, run by Mountain Diabetes and Endocrine Center at 1 site in United States.
Trial summary
The purpose of this investigator-initiated trial is to compare the effect of a daily injection of insulin degludec vs. basal insulin delivery via Continuous Subcutaneous Insulin Infusion (CSII), both in combination with bolus insulin delivery via the patient's usual insulin pump with insulin aspart, on glycemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2018to 1 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients > 18 years of age with type 1 diabetes using CSII with any pump for > 12 months.
- Females must be using adequate contraception, defined as oral contraceptive pill, barrier method of contraception, or surgical method (tubal ligation or hysterectomy).
- Good glycemic control (HbA1c < 8.0%).
- Patients are experienced in carbohydrate counting, evidenced by pump downloads showing frequent meal boluses with realistic carbohydrate entries, few over-rides of the pump bolus calculator, few to no omitted boluses (at least 3 boluses per day), and post-meal glucose levels generally below 200 mg/dl indicating accurate carbohydrate assessment.
- Patients are regular (>85% of time) users of the Dexcom G5 or G6 CGM.
- Pump download confirms correct use of insulin pump features, including appropriate use of bolus calculator with minimal overrides, entering carbohydrate content of meals, at least 3 boluses taken per day, appropriate use of correction boluses, and infusion set changes every 2 to 3 days.
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- No serious comorbidities including: retinopathy requiring active intervention, eGFR < 30, CV event within the previous 6 months, active malignancy with ongoing treatment, any condition requiring chronic use of systemic glucocorticoids, or any other condition which in the opinion of the investigator would interfere with the subject's ability to comply with the study protocol or acutely affect insulin requirements.
- Able to comply with study protocol.
- Ability to provide written informed consent prior to any study-related procedures.
- -
Who cannot join
- Subjects with type 2 diabetes.
- Subjects with HbA1c > 8.0%
- Subjects not using CSII and CGM (ie, on MDI)
- Subjects inexperienced in the use of CSII, or whose pump download shows poor utilization of bolus calculator features, ie fewer than 2 boluses per day, lack of correction boluses, frequent overrides of the recommended boluses, unrealistic carbohydrate entries (suggestive of under-bolusing), not changing infusion set at least every 3 days, or other evidence of poor insulin pump usage.
- Subjects inexperienced in or not regular users (>85% of time) of Dexcom G5 or G6 CGM
- Subjects who are using a Medtronic pump with low blood glucose suspend who are unwilling to use the Dexcom CGM or to disengage the low blood glucose suspend feature of the pump.
Show all 14Show fewer
- Use of any other CGM than Dexcom G5 or G6.
- Serious concomitant illness.
- Females unwilling to use adequate contraception, intending to become pregnant, or breastfeeding.
- Known or suspected allergy to study products, their excipients or related products.
- Previous participation in this trial. Note: subjects who screen fail because of A1c may rescreen once if, in the opinion of the investigator, the HbA1c was explainable (ie, recent steroid injection or illness, etc) and atypical for the subject.
- Hypoglycemic unawareness.
- Episode of severe hypoglycemia (requiring assistance for treatment) within the previous 90 days.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
About this study
Official title: Basal Insulin Glycemic ControL With DEglugec vs Aspart Via Pump: A Comparison of Insulin Degludec to Continuous Subcutaneous Infusion of Insulin Aspart for Basal Insulin Delivery in Type 1 Diabetes
The purpose of this investigator-initiated trial is to compare the effect of a daily injection of insulin degludec vs. basal insulin delivery via Continuous Subcutaneous Insulin Infusion (CSII), both in combination with bolus insulin delivery via the patient's usual insulin pump with insulin aspart, on glycemic variability, overall blood glucose control and incidence of hypoglycemia, all assessed by continuous glucose monitor (CGM), as well as patient satisfaction, in patients with type 1 diabetes currently using CSII.
Read the detailed description
The primary objective of this trial is to determine whether insulin degludec will provide an equally stable and consistent basal glycemic profile with lower glycemic variability as determined by Continuous Glucose Monitoring compared to insulin aspart delivered by Continuous Subcutaneous Insulin Infusion in patients with type 1 diabetes experienced in use of insulin pump therapy. Specifically, this study will determine if the percent time in the target glycemic range (70 to 180 mg/dl) by Continuous Glucose Monitoring is superior using insulin degludec than continuously infused insulin aspart, and if degludec is associated with lower glucose variability as assessed by the standard deviation (SD) of the mean daily glucose by Continuous Glucose Monitoring. Particular attention will be given to the nocturnal glucose profile (from midnight to 6 am) which most closely reflects basal insulin action as it is typically the time of day least affected by bolus insulin, food intake or exercise. Quality of life questionnaires regarding treatment preference will be used to capture patient preference for method of basal insulin delivery.
RESEARCH DESIGN AND METHODS
Study hypothesis:
It is anticipated, based on the low glycemic variability of insulin degludec shown in glucose clamp studies and seen in clinical practice, that insulin degludec will provide more stable 24 hour basal insulin action than insulin aspart by Continuous Subcutaneous Insulin Infusion (CSII) in patients with type 1 diabetes.
Primary endpoint:
Percent time in euglycemia (BG 70 to 180 mg/dl) by Continuous Glucose Monitoring (CGM) during the final 14 days of each treatment period during steady state (with basal insulin delivery as either one daily injection of insulin degludec or as insulin aspart via CSII).
Study type:
This will be a randomized, cross-over, open label, single-center study consisting of a 20 week period on each of two basal insulin delivery methods, both in combination with insulin aspart with boluses taken by insulin pump. Each 20 week period will consist of a 4 week insulin optimization period for titration of basal and bolus insulin doses, followed by a 16 week maintenance period. The final 2 weeks of the maintenance period during each treatment arm will be used for endpoint data collection. The treatment sequence will occur in random order. The study population will include patients with type 1 diabetes with good baseline glycemic control who are experienced in the use of both CSII and CGM; the cross-over design allows each subject to serve as his or her own control.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Aspart
- Keywords
- Continuous Glucose Monitoring, CGM, Continuous Subcutaneous Insulin Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspartDrug
Also called Degludec
A population of well controlled patients with type 1 diabetes who are experienced in the use of both Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitor (CGM) was chosen in order to assess the effect of the change in glycemic profile using two different methods of basal insulin delivery. Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses.
Replacing basal insulin delivery by CSII with a single daily injection of degludec will add minimal, if any, treatment burden which will be offset by potential therapeutic benefits. These benefits include the potential for reduced glycemic variability and the elimination of the risk of hyperglycemia and DKA with basal insulin interruption which can occur with infusion set occlusion or disgorging inherent to Continuous Subcutaneous Insulin Infusion.
| Study group | Role | What they receive |
|---|---|---|
| NovoLog®-only | No intervention | In the aspart-Only group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Aspart is put into their pump and delivered to their body through a small tube placed under your skin. In this NovoLog®-only treatment group, the subject will take aspart with each meal while your pump also gives you a slow, continuous dose of aspart for basal insulin. This treatment group is very similar (or even identical) to the treatment the subject was receiving prior to starting the study. |
| Novolog® and Tresiba® Group | Active comparator | This study population will have an expertise in diabetes self-management with their insulin pump and Dexcom CGM. In the Novolog® and Tresiba® group, the subject will still take aspart via their pump for meals and correction boluses, but they will reduce the slow trickle (basal insulin) programmed in their pump to almost zero. Instead of receiving their normal basal insulin via CSII, the subject will injected degludec once or twice daily from an insulin pen for your basal insulin. Receives: Drug: Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time in euglycemia (BG 70 to 180 mg/dl) by CGM
Percent time in euglycemia (BG 70 to 180 mg/dl) by CGM during the final 14 days of each treatment period during steady state (with basal insulin delivery as either one daily injection of insulin degludec or as insulin aspart via CSII)
Measured: 46 weeks
Secondary outcomes (9)
Standard Deviation (SD) of blood glucose by CGM for two week period
SD of interstitial fluid glucose by CGM for 2 week period during each basal insulin delivery method. (Note: because the Dexcom Platinum G5 CGM is currently only FDA approved for 7 days of use, two contiguous CGM periods using 2 sensors, each for 7 days, will be performed to capture 2 weeks of continuous CGM data.) Dexcom G6 is approved by FDA for 10 days of use so 2 sensors will be used during the CGM periods.
Measured: 46 weeks
SD of blood glucose by CGM during the nocturnal period
SD of blood glucose by CGM during the nocturnal period (midnight to 6 am) during each basal insulin delivery method
Measured: 46 weeks
Percent time in hypoglycemia by CGM
Percent time in hypoglycemia by CGM, captured at 2 levels of hypoglycemia: BG < 54 mg/dl (level 2) and BG 55-69 mg/dl (level 1), for each basal insulin treatment.
Measured: 46 weeks
Percent time in normoglycemia
Percent time in normoglycemia (BG 70 to 140 mg/dl) by CGM during each basal treatment period.
Measured: 46 weeks
Time to recovery from level 2 hypoglycemia
Time to recovery from level 2 hypoglycemia (BG >70 with resolution of symptoms) on each treatment. If a second event (BG < 70 mg/dl) occurs within 60 minutes of a previous hypoglycemic event, this will be considered part of the same hypoglycemic episode.
Measured: 46 weeks
Patient satisfaction
Patient satisfaction by TRIM-D questionnaires with each basal insulin treatment.
Measured: 46 weeks
Patient satisfaction
Patient satisfaction by TRIM-DD questionnaires with each basal insulin treatment.
Measured: 46 weeks
HbA1c
HbA1c after 20 weeks of each basal insulin treatment.
Measured: 46 weeks
Total daily insulin dosage
Total daily insulin dose, total basal insulin dose, and total bolus insulin dose on each treatment.
Measured: 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start12 Apr 2018
- Primary completion16 May 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type1 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
- Crossover
- Model description
- This will be a randomized, cross-over, open label, single-center study consisting of a 20 week period on each of two basal insulin delivery methods, both in combination with insulin aspart with boluses taken by insulin pump. Each 20 week period will consist of a 4 week insulin optimization period for titration of basal and bolus insulin doses, followed by a 16 week maintenance period. The final 2 weeks of the maintenance period during each treatment arm will be used for endpoint data collection. The treatment sequence will occur in random order. The study population will include patients with type 1 diabetes with good baseline glycemic control who are experienced in the use of both Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitor; the cross-over design allows each subject to serve as his or her own control.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mountain Diabetes and Endocrine Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409587
- Sponsor's protocol ID
- MDEC2018
- Acronym
- BIG LEAP
- Status last verified
- Feb 2021
- First submitted
- 30 Jul 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and statistical analysis will be available to any researcher with appropriate request
Publications
Misso ML, Egberts KJ, Page M, O'Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD005103. doi: 10.1002/14651858.CD005103.pub2.
PubMed 20091571Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.
PubMed 25998289Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012 Sep;14(9):859-64. doi: 10.1111/j.1463-1326.2012.01627.x. Epub 2012 Jun 7.
PubMed 22594461Lane W, Bailey TS, Gerety G, Gumprecht J, Philis-Tsimikas A, Hansen CT, Nielsen TSS, Warren M; Group Information; SWITCH 1. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):33-44. doi: 10.1001/jama.2017.7115.
PubMed 28672316Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
PubMed 27629148Novo Nordisk. (2015). TRESIBA® (insulin degludec injection) Label. 28-29
Novo Nordisk. (2000). NovoLog (insulin aspart [rDNA origin]) injection label. 21-22
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Insulin Glycemic ControL With DEglugec vs Aspart Via Pump: A Comparison of Insulin Degludec to Continuous Subcutaneous Infusion of Insulin Aspart for Basal Insulin Delivery in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04409587
- Acronym / sponsor ID
- BIG LEAP / MDEC2018
- Conditions
- Type1 Diabetes Mellitus
- Keywords
- Continuous Glucose Monitoring, CGM, Continuous Subcutaneous Insulin Infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mountain Diabetes and Endocrine CenterUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 16 May 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 1 Jun 2020 (actual)
- 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.
The purpose of this investigator-initiated trial is to compare the effect of a daily injection of insulin degludec vs. basal insulin delivery via Continuous Subcutaneous Insulin Infusion (CSII), both in combination with bolus insulin delivery via the patient's usual insulin pump with insulin aspart, on glycemic variability, overall blood glucose control and incidence of hypoglycemia, all assessed by continuous glucose monitor (CGM), as well as patient satisfaction, in patients with type 1 diabetes currently using CSII.
Detailed description
The primary objective of this trial is to determine whether insulin degludec will provide an equally stable and consistent basal glycemic profile with lower glycemic variability as determined by Continuous Glucose Monitoring compared to insulin aspart delivered by Continuous Subcutaneous Insulin Infusion in patients with type 1 diabetes experienced in use of insulin pump therapy. Specifically, this study will determine if the percent time in the target glycemic range (70 to 180 mg/dl) by Continuous Glucose Monitoring is superior using insulin degludec than continuously infused insulin aspart, and if degludec is associated with lower glucose variability as assessed by the standard deviation (SD) of the mean daily glucose by Continuous Glucose Monitoring. Particular attention will be given to the nocturnal glucose profile (from midnight to 6 am) which most closely reflects basal insulin action as it is typically the time of day least affected by bolus insulin, food intake or exercise. Quality of life questionnaires regarding treatment preference will be used to capture patient preference for method of basal insulin delivery.
RESEARCH DESIGN AND METHODS
Study hypothesis:
It is anticipated, based on the low glycemic variability of insulin degludec shown in glucose clamp studies and seen in clinical practice, that insulin degludec will provide more stable 24 hour basal insulin action than insulin aspart by Continuous Subcutaneous Insulin Infusion (CSII) in patients with type 1 diabetes.
Primary endpoint:
Percent time in euglycemia (BG 70 to 180 mg/dl) by Continuous Glucose Monitoring (CGM) during the final 14 days of each treatment period during steady state (with basal insulin delivery as either one daily injection of insulin degludec or as insulin aspart via CSII).
Study type:
This will be a randomized, cross-over, open label, single-center study consisting of a 20 week period on each of two basal insulin delivery methods, both in combination with insulin aspart with boluses taken by insulin pump. Each 20 week period will consist of a 4 week insulin optimization period for titration of basal and bolus insulin doses, followed by a 16 week maintenance period. The final 2 weeks of the maintenance period during each treatment arm will be used for endpoint data collection. The treatment sequence will occur in random order. The study population will include patients with type 1 diabetes with good baseline glycemic control who are experienced in the use of both CSII and CGM; the cross-over design allows each subject to serve as his or her own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a randomized, cross-over, open label, single-center study consisting of a 20 week period on each of two basal insulin delivery methods, both in combination with insulin aspart with boluses taken by insulin pump. Each 20 week period will consist of a 4 week insulin optimization period for titration of basal and bolus insulin doses, followed by a 16 week maintenance period. The final 2 weeks of the maintenance period during each treatment arm will be used for endpoint data collection. The treatment sequence will occur in random order. The study population will include patients with type 1 diabetes with good baseline glycemic control who are experienced in the use of both Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitor; the cross-over design allows each subject to serve as his or her own control.
| Arm | Type | Receives |
|---|---|---|
| NovoLog®-only | No intervention | –In the aspart-Only group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Aspart is put into their pump and delivered to their body through a small tube placed under your skin. In this NovoLog®-only treatment group, the subject will take aspart with each meal while your pump also gives you a slow, continuous dose of aspart for basal insulin. This treatment group is very similar (or even identical) to the treatment the subject was receiving prior to starting the study. |
| Novolog® and Tresiba® Group | Active comparator | Drug: AspartThis study population will have an expertise in diabetes self-management with their insulin pump and Dexcom CGM. In the Novolog® and Tresiba® group, the subject will still take aspart via their pump for meals and correction boluses, but they will reduce the slow trickle (basal insulin) programmed in their pump to almost zero. Instead of receiving their normal basal insulin via CSII, the subject will injected degludec once or twice daily from an insulin pen for your basal insulin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients > 18 years of age with type 1 diabetes using CSII with any pump for > 12 months.
- Females must be using adequate contraception, defined as oral contraceptive pill, barrier method of contraception, or surgical method (tubal ligation or hysterectomy).
- Good glycemic control (HbA1c < 8.0%).
- Patients are experienced in carbohydrate counting, evidenced by pump downloads showing frequent meal boluses with realistic carbohydrate entries, few over-rides of the pump bolus calculator, few to no omitted boluses (at least 3 boluses per day), and post-meal glucose levels generally below 200 mg/dl indicating accurate carbohydrate assessment.
- Patients are regular (>85% of time) users of the Dexcom G5 or G6 CGM.
Key exclusion criteria (14 listed)
- Subjects with type 2 diabetes.
- Subjects with HbA1c > 8.0%
- Subjects not using CSII and CGM (ie, on MDI)
- Subjects inexperienced in the use of CSII, or whose pump download shows poor utilization of bolus calculator features, ie fewer than 2 boluses per day, lack of correction boluses, frequent overrides of the recommended boluses, unrealistic carbohydrate entries (suggestive of under-bolusing), not changing infusion set at least every 3 days, or other evidence of poor insulin pump usage.
- Subjects inexperienced in or not regular users (>85% of time) of Dexcom G5 or G6 CGM
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 |
|---|---|---|
| AspartAlso: DegludecA population of well controlled patients with type 1 diabetes who are experienced in the use of both Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitor (CGM) was chosen in order to assess the effect of the change in glycemic profile using two different methods of basal insulin delivery. Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Replacing basal insulin delivery by CSII with a single daily injection of degludec will add minimal, if any, treatment burden which will be offset by potential therapeutic benefits. These benefits include the potential for reduced glycemic variability and the elimination of the risk of hyperglycemia and DKA with basal insulin interruption which can occur with infusion set occlusion or disgorging inherent to Continuous Subcutaneous Insulin Infusion. | Drug | Novolog® and Tresiba® Group |
Primary outcome
Percent time in euglycemia (BG 70 to 180 mg/dl) by CGM
Time frame: 46 weeks
Percent time in euglycemia (BG 70 to 180 mg/dl) by CGM during the final 14 days of each treatment period during steady state (with basal insulin delivery as either one daily injection of insulin degludec or as insulin aspart via CSII)
9 secondary outcomes
Standard Deviation (SD) of blood glucose by CGM for two week period
Time frame: 46 weeks
SD of blood glucose by CGM during the nocturnal period
Time frame: 46 weeks
Percent time in hypoglycemia by CGM
Time frame: 46 weeks
Percent time in normoglycemia
Time frame: 46 weeks
Time to recovery from level 2 hypoglycemia
Time frame: 46 weeks
Patient satisfaction
Time frame: 46 weeks
Patient satisfaction
Time frame: 46 weeks
HbA1c
Time frame: 46 weeks
Total daily insulin dosage
Time frame: 46 weeks
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 24 Feb 2021.
- Results publication: PubMed 20091571Misso ML, Egberts KJ, Page M, O'Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD005103. doi: 10.1002/14651858.CD005103.pub2.
- Results publication: PubMed 25998289Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.
- Results publication: PubMed 22594461Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012 Sep;14(9):859-64. doi: 10.1111/j.1463-1326.2012.01627.x. Epub 2012 Jun 7.
- Results publication: PubMed 28672316Lane W, Bailey TS, Gerety G, Gumprecht J, Philis-Tsimikas A, Hansen CT, Nielsen TSS, Warren M; Group Information; SWITCH 1. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):33-44. doi: 10.1001/jama.2017.7115.
- Results publication: PubMed 27629148Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
- Results publicationNovo Nordisk. (2015). TRESIBA® (insulin degludec injection) Label. 28-29
- Results publicationNovo Nordisk. (2000). NovoLog (insulin aspart [rDNA origin]) injection label. 21-22
- Hauzenber JR et al. Diab Technol Therapeutics 2017Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data and statistical analysis will be available to any researcher with appropriate request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aspart in people with Type1 Diabetes Mellitus, run by Mountain Diabetes and Endocrine Center 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 10 inclusion and 14 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 24 Feb 2021. 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.
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?
Percent time in euglycemia (BG 70 to 180 mg/dl) by CGM (time frame: 46 weeks). 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 NCT04409587, which also lists 7 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 24 Feb 2021.