Type 1 DiabetesNCT04509362
An 8-Day Initiation of Advanced Hybrid Closed Loop System In Children and Adolescents
An observational study of Type 1 Diabetes, run by Sidra Medicine at 1 site in Qatar.
Trial summary
One of the available Hybrid closed loop system is MiniMed 670G (Medtronic Diabetes, Northridge, CA, USA), which is indicated for children above 7 years old, adolescents and adults with Type 1 Diabetes. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Advanced Hybrid Closed Loop System
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteQatar
- Study dates
- 1 Oct 2020to 1 Sep 2021
- 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 7 to 18 years
- All sexes
- Child, Adult
Study population: Participants with Type 1 Diabetes, on multiple daily injections, using self-monitoring of blood glucose or continuous glucose monitoring, no prior pump experience.
Who may be able to join
- Clinical diagnosis of type 1 diabetes >1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- HbA1c < 12.5%
- Age 7-17 years at the initiation of the system
- Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
- Willing and able (access to internet from home) to download information into the Medtronic CareLink software
- Clinically able to start the AHCL system
- History of 3 clinic visits in the last year
Who cannot join
- DKA in the 6 months prior to screening visit
- Pregnancy
- Untreated diabetes retinopathy, or other causes that ,in the investigator's opinion, precludes the individual from participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 8-Day Initiation Protocol of Advanced Hybrid Closed Loop System In Children and Adolescents With Diabetes Type 1 On Multiple Daily Insulin Injection
One of the available Hybrid closed loop system is MiniMed 670G (Medtronic Diabetes, Northridge, CA, USA), which is indicated for children above 7 years old, adolescents and adults with Type 1 Diabetes. Several studies have shown improved HbA1c, time in target range, and SG variability in children, adolescents and adults with Type 1 Diabetes, where participants were experienced with using CSII therapy, assuming that the success of HCL systems depend on prior use of pump therapy. A recent study, published by diabetes team from Sidra Medicine, Doha has showed that children and adolescents with Type 1 Diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol, achieving better outcomes than in previous studies, where participants had previous experience with diabetes related technology and longer initiation process.
The AHCL system, Minimed 780G is CE-marked includes additional functionality aiming to provide further protections from highs. The user can choose the algorithm to target a glucose level of 100 or 120 mg/dL. Like for the MiniMed 670G HCL system, users can also choose the algorithm to temporarily target a glucose value of 150 mg/dL. In addition, the AHCL system has the ability to administer correction bolus automatically, targeting 120 mg/dL. The AHCL algorithm was evaluated with a model-based algorithm design platform incorporating a virtual patient simulator, where additional changes were made (lower target ranges and automated correction boluses ( )). A recent study including 12 patients with type 1 diabetes on AHCL system, has shown no episodes of hypoglycemia or diabetic ketoacidosis, while maintaining 99% time spent in closed loop and high time in ra1]\nge ( ). AHCL decreased Auto Mode exits and alerts, and improves glycaemia without compromising safety, despite multiple food and exercise challenges ( ).
Sidra Medicine is the only center for childhood diabetes in Qatar. Around 80% of type 1 diabetes patients are using a device (insulin pump/glucose sensor) and around 45% are using sensor-augmented pump (SAP)/HCL systems.
Read the detailed description
This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months.
The study will include an 9-month extension phase, to which participants may voluntarily decide to take part in, cumulating a total of one-year period duration. Visits wil be scheduled every 3 months, as per routine practice. TIR, HbA1c, demographics and clinical data will be analyzed on 3 months period.
A total of 33 subjects (age 7-17 years) will be enrolled in order to reach 30 subjects who will complete the 3 months study.
After reviewing the patient's eligibility and interest, the investigators will obtain informed consent and assent as appropriate. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. A clinically obtained HbA1c assessment will be performed via fingerstick and DCA 2000 at baseline and 3 months during the study.
Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium) and will be kept as electronic data on a separate research server.
The different continuous baseline values will be checked for normality of distribution using the mean-median comparison, skewness and kurtosis (-3 to +3), spread, Kolmogorov-Smirnow and Shapiro-Wild tests, outliers, histograms and Q-Q-plots.
The initiation protocol consisted of four main stages: AHCL system compatibility assessment, AHCL system training, Manual Mode and Auto Mode stages.
Step 1. AHCL system compatibility assessment
Step 1 will be used to select participants for the study, based on inclusion and exclusion criteria (explained below) as well as patients' interest. It consists of 2 sessions:
AHCL System Introduction session (Clinic visit), one-hour duration (groups of 8-12 patients), where the AHCL system will be explained. Individuals' responsibilities (e.g. bolusing before meal, calibrating the system 3-4 times per day, responding to alerts and alarms, downloading pump data from home) and expectations (e.g. improvements in glycemic control, less glucose variability, hypoglycemia minimization, workload of diabetes management) will be discussed.
AHCL System readiness session, 1-hour duration, where evaluation will be performed on carb counting, bolus for carbs and correction, SMBG. Participants will send food log diary and phone call consultation will be performed.
Step 2: AHCL system training
A similar approach currently used in Sidra for MiniMed 670G system initiation will be used in the study. AHCL system training will be performed in groups (three to five individuals and their parents/guardians). The program includes three sessions of two to three hours on three consecutive days. CGM will be initiated the first day of the training, for education and observational purposes and for baseline data collection (no insulin delivery by the pump) Details are explained in the table:
Each session will be provided by two educators from 12pm to 3pm. Timing of the long acting insulin injection will be moved two hours ahead each day during training sessions, to reach 12pm the day before the HCL system initiation in Manual Mode, to avoid the use of temporary basal at insulin pump initiation.
Step 3: Manual Mode Participants will initiate the use of the AHCL system in Manual Mode (Clinic visit) with suspend before low feature for 72 hours to allow the algorithm to collect insulin utilization and CGM data to establish personalized Auto Mode initiation parameters. Sidra's validated protocol for SAP initiation (Auto-Generator app), also used in 10-day initiation protocol, with review of CGM data (step 2) will be used: in short, the protocol inputs the current insulin program (MDI), calculates a 10 to 20% reduction of total daily dose, with a 40/60 basal/bolus distribution in four or five basal rates. Insulin to carbohydrate ratio (ICR) settings utilizes the formula of 300-450/Total Daily dose (TDD) and, the formula of 90-110/TDD (mmol/l) with two CF settings, the nighttime CF factor is set 10-20% higher than the daytime CF. Active insulin is set time (3 hours), suspend before low feature is turned on with a threshold of 3.0-3.8 mmol/l (55-70 mg/dl) and glucose target range from 5.0 mmol/l to 7.2 mmol/l (90-130 mg/dl).
Step 4: Auto Mode The Auto Mode feature of the AHCL system will be activated 72 hours after manual mode initiation (virtual visit, using Skype Meet) and will be used continuously for 84 days.
The patient/family will upload data into the CareLink system, and the data will be reviewed by a member of the clinical team. Adjustments to system settings will be suggested to the family as clinically appropriate. The rationale for system setting adjustments will be documented.
Follow up visits will be performed on 7, 14, 28 days of aHCL initiation. After the first month of aHCL system, visits will be every three months during the study.
HbA1c will be obtained using point of care DCA Vantage Analyzer (Siemens, Erlangen, Germany) at baseline and at the end of the study.
The study will submit the proposal to Local and National Ethics Committee in Qatar to get Ethical approval before commencing the study.
- Conditions
- Type 1 Diabetes
- Being tested
- Advanced Hybrid Closed Loop System
- Keywords
- Type 1 Diabetes, Advanced Hybrid Closed Loop System, Minimed 780G, Initiation Protocol
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Hybrid Closed Loop SystemDevice
Also called Minimed 780G
Evaluation of the use of an 8-day structured protocol to initiate patients from MDI to the AHCL system, in achieving safe glycemic control
What is being measured
The primary outcome is the main question the study is designed to answer.
TIR (70-180 mg/dl)
Change from baseline to the first 3 months
Measured: 3 months
TIR (70-180 mg/dl
Change from baseline to the 12 months
Measured: 12 months
Secondary outcomes (10)
HbA1c change
Change in HbA1c from Baseline to 3 months
Measured: 3 months
HbA1c change
Change in HbA1c from Baseline to 12 months
Measured: 12 months
Sensor glucose wear
Change in Sensor glucose wear from Baseline to 3 months
Measured: 3 months
Sensor glucose wear
Change in Sensor glucose wear from Baseline to 12 months
Measured: 12 months
Auto Mode Usage
Change in Auto Mode Usage from Baseline to 3 months
Measured: 3 months
Auto Mode Usage
Change in Auto Mode Usage from Baseline to 12 months
Measured: 12 months
Severe Hypoglycemia
Number of events in the first 3 months
Measured: 3 months
Severe Hypoglycemia
Number of events in the 12 months
Measured: 12 months
Diabetic Ketoacidosis
Number of events in the first 3 months
Measured: 3 months
Diabetic Ketoacidosis
Number of events in 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Oct 2020
- Primary completion31 May 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidra Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509362
- Sponsor's protocol ID
- 00009930
- Status last verified
- Sep 2021
- First submitted
- 1 Aug 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It depends on Institution decision, waiting response
Publications
Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
PubMed 28134564Grosman B, Wu D, Miller D, Lintereur L, Roy A, Parikh N, Kaufman FR. Sensor-Augmented Pump-Based Customized Mathematical Model for Type 1 Diabetes. Diabetes Technol Ther. 2018 Mar;20(3):207-221. doi: 10.1089/dia.2017.0333.
PubMed 29565722Paldus B, Lee MH, Jones HM, McAuley SA, Horsburgh JC, Roem KL, Ward GM, MacIsaac RJ, Cohen N, Colman PG, Jenkins AJ, O'Neal DN. Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study. Diabetes Technol Ther. 2019 Jan;21(1):56-58. doi: 10.1089/dia.2018.0279.
PubMed 30620641Thabit H, Hovorka R. Coming of age: the artificial pancreas for type 1 diabetes. Diabetologia. 2016 Sep;59(9):1795-805. doi: 10.1007/s00125-016-4022-4. Epub 2016 Jun 30.
PubMed 27364997Biester T, Nir J, Remus K, Farfel A, Muller I, Biester S, Atlas E, Dovc K, Bratina N, Kordonouri O, Battelino T, Philip M, Danne T, Nimri R. DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home. Diabetes Obes Metab. 2019 Apr;21(4):822-828. doi: 10.1111/dom.13585. Epub 2018 Dec 21.
PubMed 30478937U.S. Food and Drug Administration (2019) FDA approves first automated insulin delivery device for type 1 diabetes. Available from www.fda.gov/news-events/press-announcements/fda-approves-first-automated-insulin-delivery-device-type-1-diabetes. Accessed 21 March 2019
Weaver KW, Hirsch IB. The Hybrid Closed-Loop System: Evolution and Practical Applications. Diabetes Technol Ther. 2018 Jun;20(S2):S216-S223. doi: 10.1089/dia.2018.0091. Epub 2018 Jun 6.
PubMed 29873517Trevitt S, Simpson S, Wood A. Artificial Pancreas Device Systems for the Closed-Loop Control of Type 1 Diabetes: What Systems Are in Development? J Diabetes Sci Technol. 2016 May 3;10(3):714-23. doi: 10.1177/1932296815617968. Print 2016 May.
PubMed 26589628Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, Shulman DI, Bailey TS, Bode BW, Wood MA, Buckingham BA, Kaiserman KB, Shin J, Huang S, Lee SW, Kaufman FR. Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jan;21(1):11-19. doi: 10.1089/dia.2018.0264. Epub 2018 Dec 26.
PubMed 30585770Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. 10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes. Acta Diabetol. 2020 Jun;57(6):681-687. doi: 10.1007/s00592-019-01472-w. Epub 2020 Jan 17.
PubMed 31953687
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Day Initiation Protocol of Advanced Hybrid Closed Loop System In Children and Adolescents With Diabetes Type 1 On Multiple Daily Insulin Injection
- ClinicalTrials.gov ID
- NCT04509362
- Acronym / sponsor ID
- 00009930
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Advanced Hybrid Closed Loop System, Minimed 780G, Initiation Protocol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sidra MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 12 Aug 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.
One of the available Hybrid closed loop system is MiniMed 670G (Medtronic Diabetes, Northridge, CA, USA), which is indicated for children above 7 years old, adolescents and adults with Type 1 Diabetes. Several studies have shown improved HbA1c, time in target range, and SG variability in children, adolescents and adults with Type 1 Diabetes, where participants were experienced with using CSII therapy, assuming that the success of HCL systems depend on prior use of pump therapy. A recent study, published by diabetes team from Sidra Medicine, Doha has showed that children and adolescents with Type 1 Diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol, achieving better outcomes than in previous studies, where participants had previous experience with diabetes related technology and longer initiation process.
The AHCL system, Minimed 780G is CE-marked includes additional functionality aiming to provide further protections from highs. The user can choose the algorithm to target a glucose level of 100 or 120 mg/dL. Like for the MiniMed 670G HCL system, users can also choose the algorithm to temporarily target a glucose value of 150 mg/dL. In addition, the AHCL system has the ability to administer correction bolus automatically, targeting 120 mg/dL. The AHCL algorithm was evaluated with a model-based algorithm design platform incorporating a virtual patient simulator, where additional changes were made (lower target ranges and automated correction boluses ( )). A recent study including 12 patients with type 1 diabetes on AHCL system, has shown no episodes of hypoglycemia or diabetic ketoacidosis, while maintaining 99% time spent in closed loop and high time in ra1]\nge ( ). AHCL decreased Auto Mode exits and alerts, and improves glycaemia without compromising safety, despite multiple food and exercise challenges ( ).
Sidra Medicine is the only center for childhood diabetes in Qatar. Around 80% of type 1 diabetes patients are using a device (insulin pump/glucose sensor) and around 45% are using sensor-augmented pump (SAP)/HCL systems.
Detailed description
This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months.
The study will include an 9-month extension phase, to which participants may voluntarily decide to take part in, cumulating a total of one-year period duration. Visits wil be scheduled every 3 months, as per routine practice. TIR, HbA1c, demographics and clinical data will be analyzed on 3 months period.
A total of 33 subjects (age 7-17 years) will be enrolled in order to reach 30 subjects who will complete the 3 months study.
After reviewing the patient's eligibility and interest, the investigators will obtain informed consent and assent as appropriate. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. A clinically obtained HbA1c assessment will be performed via fingerstick and DCA 2000 at baseline and 3 months during the study.
Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium) and will be kept as electronic data on a separate research server.
The different continuous baseline values will be checked for normality of distribution using the mean-median comparison, skewness and kurtosis (-3 to +3), spread, Kolmogorov-Smirnow and Shapiro-Wild tests, outliers, histograms and Q-Q-plots.
The initiation protocol consisted of four main stages: AHCL system compatibility assessment, AHCL system training, Manual Mode and Auto Mode stages.
Step 1. AHCL system compatibility assessment
Step 1 will be used to select participants for the study, based on inclusion and exclusion criteria (explained below) as well as patients' interest. It consists of 2 sessions:
AHCL System Introduction session (Clinic visit), one-hour duration (groups of 8-12 patients), where the AHCL system will be explained. Individuals' responsibilities (e.g. bolusing before meal, calibrating the system 3-4 times per day, responding to alerts and alarms, downloading pump data from home) and expectations (e.g. improvements in glycemic control, less glucose variability, hypoglycemia minimization, workload of diabetes management) will be discussed.
AHCL System readiness session, 1-hour duration, where evaluation will be performed on carb counting, bolus for carbs and correction, SMBG. Participants will send food log diary and phone call consultation will be performed.
Step 2: AHCL system training
A similar approach currently used in Sidra for MiniMed 670G system initiation will be used in the study. AHCL system training will be performed in groups (three to five individuals and their parents/guardians). The program includes three sessions of two to three hours on three consecutive days. CGM will be initiated the first day of the training, for education and observational purposes and for baseline data collection (no insulin delivery by the pump) Details are explained in the table:
Each session will be provided by two educators from 12pm to 3pm. Timing of the long acting insulin injection will be moved two hours ahead each day during training sessions, to reach 12pm the day before the HCL system initiation in Manual Mode, to avoid the use of temporary basal at insulin pump initiation.
Step 3: Manual Mode Participants will initiate the use of the AHCL system in Manual Mode (Clinic visit) with suspend before low feature for 72 hours to allow the algorithm to collect insulin utilization and CGM data to establish personalized Auto Mode initiation parameters. Sidra's validated protocol for SAP initiation (Auto-Generator app), also used in 10-day initiation protocol, with review of CGM data (step 2) will be used: in short, the protocol inputs the current insulin program (MDI), calculates a 10 to 20% reduction of total daily dose, with a 40/60 basal/bolus distribution in four or five basal rates. Insulin to carbohydrate ratio (ICR) settings utilizes the formula of 300-450/Total Daily dose (TDD) and, the formula of 90-110/TDD (mmol/l) with two CF settings, the nighttime CF factor is set 10-20% higher than the daytime CF. Active insulin is set time (3 hours), suspend before low feature is turned on with a threshold of 3.0-3.8 mmol/l (55-70 mg/dl) and glucose target range from 5.0 mmol/l to 7.2 mmol/l (90-130 mg/dl).
Step 4: Auto Mode The Auto Mode feature of the AHCL system will be activated 72 hours after manual mode initiation (virtual visit, using Skype Meet) and will be used continuously for 84 days.
The patient/family will upload data into the CareLink system, and the data will be reviewed by a member of the clinical team. Adjustments to system settings will be suggested to the family as clinically appropriate. The rationale for system setting adjustments will be documented.
Follow up visits will be performed on 7, 14, 28 days of aHCL initiation. After the first month of aHCL system, visits will be every three months during the study.
HbA1c will be obtained using point of care DCA Vantage Analyzer (Siemens, Erlangen, Germany) at baseline and at the end of the study.
The study will submit the proposal to Local and National Ethics Committee in Qatar to get Ethical approval before commencing the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Participants with Type 1 Diabetes, on multiple daily injections, using self-monitoring of blood glucose or continuous glucose monitoring, no prior pump experience.
Key inclusion criteria (7 listed)
- Clinical diagnosis of type 1 diabetes >1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- HbA1c < 12.5%
- Age 7-17 years at the initiation of the system
- Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
- Willing and able (access to internet from home) to download information into the Medtronic CareLink software
Key exclusion criteria (3 listed)
- DKA in the 6 months prior to screening visit
- Pregnancy
- Untreated diabetes retinopathy, or other causes that ,in the investigator's opinion, precludes the individual from participating in the trial.
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 |
|---|---|---|
| Advanced Hybrid Closed Loop SystemAlso: Minimed 780GEvaluation of the use of an 8-day structured protocol to initiate patients from MDI to the AHCL system, in achieving safe glycemic control | Device | – |
Primary outcome
TIR (70-180 mg/dl)
Time frame: 3 months
Change from baseline to the first 3 months
TIR (70-180 mg/dl
Time frame: 12 months
Change from baseline to the 12 months
10 secondary outcomes
HbA1c change
Time frame: 3 months
HbA1c change
Time frame: 12 months
Sensor glucose wear
Time frame: 3 months
Sensor glucose wear
Time frame: 12 months
Auto Mode Usage
Time frame: 3 months
Auto Mode Usage
Time frame: 12 months
Severe Hypoglycemia
Time frame: 3 months
Severe Hypoglycemia
Time frame: 12 months
Diabetic Ketoacidosis
Time frame: 3 months
Diabetic Ketoacidosis
Time frame: 12 months
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 28 Sep 2021.
- Background: PubMed 28134564Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
- Background: PubMed 29565722Grosman B, Wu D, Miller D, Lintereur L, Roy A, Parikh N, Kaufman FR. Sensor-Augmented Pump-Based Customized Mathematical Model for Type 1 Diabetes. Diabetes Technol Ther. 2018 Mar;20(3):207-221. doi: 10.1089/dia.2017.0333.
- Background: PubMed 30620641Paldus B, Lee MH, Jones HM, McAuley SA, Horsburgh JC, Roem KL, Ward GM, MacIsaac RJ, Cohen N, Colman PG, Jenkins AJ, O'Neal DN. Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study. Diabetes Technol Ther. 2019 Jan;21(1):56-58. doi: 10.1089/dia.2018.0279.
- Results publication: PubMed 27364997Thabit H, Hovorka R. Coming of age: the artificial pancreas for type 1 diabetes. Diabetologia. 2016 Sep;59(9):1795-805. doi: 10.1007/s00125-016-4022-4. Epub 2016 Jun 30.
- Results publication: PubMed 30478937Biester T, Nir J, Remus K, Farfel A, Muller I, Biester S, Atlas E, Dovc K, Bratina N, Kordonouri O, Battelino T, Philip M, Danne T, Nimri R. DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home. Diabetes Obes Metab. 2019 Apr;21(4):822-828. doi: 10.1111/dom.13585. Epub 2018 Dec 21.
- Results publicationU.S. Food and Drug Administration (2019) FDA approves first automated insulin delivery device for type 1 diabetes. Available from www.fda.gov/news-events/press-announcements/fda-approves-first-automated-insulin-delivery-device-type-1-diabetes. Accessed 21 March 2019
- Results publication: PubMed 29873517Weaver KW, Hirsch IB. The Hybrid Closed-Loop System: Evolution and Practical Applications. Diabetes Technol Ther. 2018 Jun;20(S2):S216-S223. doi: 10.1089/dia.2018.0091. Epub 2018 Jun 6.
- Results publication: PubMed 26589628Trevitt S, Simpson S, Wood A. Artificial Pancreas Device Systems for the Closed-Loop Control of Type 1 Diabetes: What Systems Are in Development? J Diabetes Sci Technol. 2016 May 3;10(3):714-23. doi: 10.1177/1932296815617968. Print 2016 May.
- Results publication: PubMed 30585770Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, Shulman DI, Bailey TS, Bode BW, Wood MA, Buckingham BA, Kaiserman KB, Shin J, Huang S, Lee SW, Kaufman FR. Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jan;21(1):11-19. doi: 10.1089/dia.2018.0264. Epub 2018 Dec 26.
- Results publication: PubMed 31953687Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. 10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes. Acta Diabetol. 2020 Jun;57(6):681-687. doi: 10.1007/s00592-019-01472-w. Epub 2020 Jan 17.
- Individual participant dataSharing planned: Undecided. It depends on Institution decision, waiting response
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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?
An observational study of Type 1 Diabetes, run by Sidra Medicine at 1 site in Qatar.
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 3 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 28 Sep 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 Qatar. 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?
TIR (70-180 mg/dl) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04509362, which also lists 10 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 28 Sep 2021.