Diabetes type1780GGSNCT05069727
Simple Initiation of Advanced Hybrid Closed Loop System
A study testing Regular Protocol with advanced carbohydrate counting and Simplified Protocol with fixed carbohydrate content in people with Diabetes type1, run by Sidra Medicine at 1 site in Qatar.
Trial summary
Background and Aim. The new and advanced hybrid closed loop (AHCL) system MiniMed 780G automatically adjusts basal insulin delivery in addition to automated bolus corrections, based on continuous glucose monitoring (CGM) readings, to offer protection against both hyperglycemia and hypoglycemia. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes type1
- What is being tested?
- Regular Protocol with advanced carbohydrate counting and Simplified Protocol with fixed carbohydrate content
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteQatar
- Study dates
- 21 Nov 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes >0.5 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.
- Age 12-18 years and above at the initiation of the system
- 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)
- Clinically able to start the AHCL system
Who cannot join
- Pregnancy
- Untreated diabetes retinopathy, or other causes that in the investigator's opinion , precludes the individual from participating in the trial.
- Currently in other Clinical Trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Levels of Health Care Interactions in Adolescents With Type 1 Diabetes on Advanced Hybrid Closed Loop System MiniMed 780G/ Zeus Sensor
Background and Aim. The new and advanced hybrid closed loop (AHCL) system MiniMed 780G automatically adjusts basal insulin delivery in addition to automated bolus corrections, based on continuous glucose monitoring (CGM) readings, to offer protection against both hyperglycemia and hypoglycemia.
The objective of this study is to evaluate whether a simplified approach for patients' follow up using preset of pump settings and a simplified meal announcement, followed by minimal interaction can achieve similar glycemic control of AHCL system MiniMed 780G with Guardian Sensor 4 than a regular protocol that is currently used in adolescents with Type 1 Diabetes (T1D).
Read more
Methods. This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. A total of 34 individuals (age 12-18 years) will be enrolled to reach 30 individuals who will complete the 3 months study. Participants will be randomized in two groups: Group 1, Regular Clinical Protocol, 17 participants and Group 2, Simplified Clinical Protocol, 17 participants.
All patients will be recruited during the regular clinic visits to the outpatient Endocrine Clinics at Sidra Medicine in Doha. Patients will be chosen on a first-come first-served basis. Inclusion criteria: Clinical diagnosis of type 1 diabetes, , Age 12-18 years, Basal Bolus therapy >8.0 units per day. Exclusion criteria: Diabetic Ketoacidosis (DKA) in the 6 months prior to screening visit. The initiation protocol consists of four stages: HCL system compatibility assessment, HCL system training, Manual Mode Start and Auto Mode start. Patients will have 7 visits in a period of 3 months after initiation of insulin pump therapy.
Pump initiation: Group 1, Finetune ICR, Target 100 or 110 mg/dl and AIT: 2-3 hour and Group 2, Carb Ratio by formula 360 / TDD, ICR 8-10 (TDD 40-60), ICR 5-7 (TDD >60), Target 100 mg/dl, AIT: 2 hours with fixed meals Results. No group difference in Time in Range (TIR) (70-180mg/dl) > 70% and HbA1c < 7.5% in a period of 3 months after initiation of AHCL.
Conclusion. Conclusions will be drawn on completion of the study and evaluation of the results.
Read the detailed description
This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months.
A total of 34 individuals (age 12-18 years) will be enrolled to reach 30 individuals who will complete the 3 months study.
Participants will be randomized in two groups:
- Group 1, Regular Clinical Protocol, 17 participants
- Group 2, Simplified Clinical Protocol, 17 participants Intervention Description
- Intervention in Group 2, Simplified protocol.
- Insulin Carb Ratio (ICR) by formula 360 / Total Daily Dose (TDD)
- ICR 8-10 (TDD 40-60)
- ICR 5-7 (TDD >60)
- Target 100 mg/dl
- Active Insulin Time (AIT): 2 hours
- Meals: Thee sets of meal set of meals announcement carbs calculated by the following formula:
- Regular meal: Total Carbs per Day x 0.6 / 3
- Large meal: Total Carbs per Day x 0.6 / 3 x 1.5
- Small (Snack) meal: Total Carbs per Day x 0.6 / 3 x 1.5 * Efficacy The efficacy shall be measured Time in Ranges (provided by CGM data), for Time in Range (70-180mg/dl), Time below Range(<70mg/dl) and Time above Range (>180 mg/dl) in the third month of the study.
- Conditions
- Diabetes type1
- Being tested
- Regular Protocol with advanced carbohydrate counting, Simplified Protocol with fixed carbohydrate content
- Keywords
- Automated Insulin Delivery, Time in Range, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Protocol with advanced carbohydrate countingProcedure or surgery
- Review 3 Days CGM data in Manual Mode
- Carb Ratio by formula 360 / TDD
- Finetune ICR
- Target 100 or 110 mg/dl
- AIT: 2-3 hour
- Insulin Bolus for meal (advanced carb counting)
- The parameters will be set using clinical assessment and fine-tuned if needed on F-up visits.
- Follow up visits will be scheduled Day 7, 14,28, 56 and 84 after enabling SmartGuard (AHCL use).
Simplified Protocol with fixed carbohydrate contentProcedure or surgery
- Review 3 Days CGM data in Manual Mode
- Carb Ratio by formula 360 / TDD ICR 8-10 (TDD 40-60) ICR 5-7 (TDD >60)
- Target 100 mg/dl
- AIT: 2 hours
- Insulin Bolus for meal (Thee sets of meal set of meals announcement carbs will be provided) Regular meal: Total Carbs per Day x 0.6 / 3 Large meal: Total Carbs per Day x 0.6 / 3 x 1.5 Small (Snack) meal: Total Carbs per Day x 0.6 / 3 x 1.5
- Total carbs per day will be calculated as average on 7-days Food Logbook diary, provided by participant, one week before AHCL initiation.
- The parameters will be fixed and fine-tuned only in case of hypoglycemia on F-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, Regular Protocol | Active comparator | Participants will bolus (insulin), based on carbohydrate content in each meal Receives: Procedure: Regular Protocol with advanced carbohydrate counting |
| Group 2, Simplified protocol | Experimental | Participants will bolus (insulin), based on three sets of meal set of meals announcement Receives: Procedure: Simplified Protocol with fixed carbohydrate content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range( 70-180 mg/dl)
Group change in the third month of AHCL use
Measured: Third month
Secondary outcomes (6)
HbA1c
Change between groups
Measured: 3 months
Average Sensor Glucose
Change between groups
Measured: 3 months
Time Bellow Range (<70 mg/dl, <54 mg/dl)
Change between groups
Measured: 3 months
Time Above Range (>180 mg/dl)
Change between groups
Measured: 3 months
Diabetic Ketoacidosis
Number of events in each group
Measured: 3 months
Severe Hypoglycemia
Number of events in each group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start21 Nov 2021
- Primary completion30 Jun 2022
- Study completion31 Aug 2022
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 Diabetes type1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. Participants will be randomized in two groups: * Group 1, Regular Clinical Protocol, 17 participants * Group 2, Simplified Clinical Protocol, 17 participants
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidra Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Petrovski, Sidra Medicine
- Investigators
- Goran Petrovski, PhD, Principal investigator, Sidra Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069727
- Sponsor's protocol ID
- 600121
- Acronym
- 780GGS
- Status last verified
- Apr 2023
- First submitted
- 26 Sep 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. From Multiple Daily Injections to Hybrid Closed-Loop System in Ten Days, Utilizing a Structured Initiation Protocol. J Diabetes Sci Technol. 2020 May;14(3):689-690. doi: 10.1177/1932296819895509. Epub 2019 Dec 26. No abstract available.
PubMed 31876178Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.
PubMed 33453783Beato-Vibora PI, Gallego-Gamero F, Ambrojo-Lopez A, Gil-Poch E, Martin-Romo I, Arroyo-Diez FJ. Rapid Improvement in Time in Range After the Implementation of an Advanced Hybrid Closed-Loop System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Sep;23(9):609-615. doi: 10.1089/dia.2021.0037. Epub 2021 Apr 20.
PubMed 33784187Lee MH, Vogrin S, Paldus B, Jones HM, Obeyesekere V, Sims C, Wyatt SA, Ward GM, McAuley SA, MacIsaac RJ, Krishnamurthy B, Sundararajan V, Jenkins AJ, O'Neal DN. Glucose Control in Adults with Type 1 Diabetes Using a Medtronic Prototype Enhanced-Hybrid Closed-Loop System: A Feasibility Study. Diabetes Technol Ther. 2019 Sep;21(9):499-506. doi: 10.1089/dia.2019.0120. Epub 2019 Jul 2.
PubMed 31264889Paldus 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 30620641Petrovski 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 31953687Petrovski G, Campbell J, Pasha M, Hussain K, Khalifa A, Umer F, Almajaly D, Hamdar M, Heuvel TVD, Edd SN. Twelve-Month Follow-up from a Randomized Controlled Trial of Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents with Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed-Loop System. Diabetes Technol Ther. 2024 Mar;26(S3):76-83. doi: 10.1089/dia.2023.0429.
PubMed 38377327
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Levels of Health Care Interactions in Adolescents With Type 1 Diabetes on Advanced Hybrid Closed Loop System MiniMed 780G/ Zeus Sensor
- ClinicalTrials.gov ID
- NCT05069727
- Acronym / sponsor ID
- 780GGS / 600121
- Conditions
- Diabetes type1
- Keywords
- Automated Insulin Delivery, Time in Range, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sidra MedicineUniversity, hospital or other
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Oct 2021 (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.
Background and Aim. The new and advanced hybrid closed loop (AHCL) system MiniMed 780G automatically adjusts basal insulin delivery in addition to automated bolus corrections, based on continuous glucose monitoring (CGM) readings, to offer protection against both hyperglycemia and hypoglycemia.
The objective of this study is to evaluate whether a simplified approach for patients' follow up using preset of pump settings and a simplified meal announcement, followed by minimal interaction can achieve similar glycemic control of AHCL system MiniMed 780G with Guardian Sensor 4 than a regular protocol that is currently used in adolescents with Type 1 Diabetes (T1D).
Methods. This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. A total of 34 individuals (age 12-18 years) will be enrolled to reach 30 individuals who will complete the 3 months study. Participants will be randomized in two groups: Group 1, Regular Clinical Protocol, 17 participants and Group 2, Simplified Clinical Protocol, 17 participants.
All patients will be recruited during the regular clinic visits to the outpatient Endocrine Clinics at Sidra Medicine in Doha. Patients will be chosen on a first-come first-served basis. Inclusion criteria: Clinical diagnosis of type 1 diabetes, , Age 12-18 years, Basal Bolus therapy >8.0 units per day. Exclusion criteria: Diabetic Ketoacidosis (DKA) in the 6 months prior to screening visit. The initiation protocol consists of four stages: HCL system compatibility assessment, HCL system training, Manual Mode Start and Auto Mode start. Patients will have 7 visits in a period of 3 months after initiation of insulin pump therapy.
Pump initiation: Group 1, Finetune ICR, Target 100 or 110 mg/dl and AIT: 2-3 hour and Group 2, Carb Ratio by formula 360 / TDD, ICR 8-10 (TDD 40-60), ICR 5-7 (TDD >60), Target 100 mg/dl, AIT: 2 hours with fixed meals Results. No group difference in Time in Range (TIR) (70-180mg/dl) > 70% and HbA1c < 7.5% in a period of 3 months after initiation of AHCL.
Conclusion. Conclusions will be drawn on completion of the study and evaluation of the results.
Detailed description
This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months.
A total of 34 individuals (age 12-18 years) will be enrolled to reach 30 individuals who will complete the 3 months study.
Participants will be randomized in two groups:
- Group 1, Regular Clinical Protocol, 17 participants
- Group 2, Simplified Clinical Protocol, 17 participants Intervention Description
- Intervention in Group 2, Simplified protocol.
- Insulin Carb Ratio (ICR) by formula 360 / Total Daily Dose (TDD)
- ICR 8-10 (TDD 40-60)
- ICR 5-7 (TDD >60)
- Target 100 mg/dl
- Active Insulin Time (AIT): 2 hours
- Meals: Thee sets of meal set of meals announcement carbs calculated by the following formula:
- Regular meal: Total Carbs per Day x 0.6 / 3
- Large meal: Total Carbs per Day x 0.6 / 3 x 1.5
- Small (Snack) meal: Total Carbs per Day x 0.6 / 3 x 1.5 * Efficacy The efficacy shall be measured Time in Ranges (provided by CGM data), for Time in Range (70-180mg/dl), Time below Range(<70mg/dl) and Time above Range (>180 mg/dl) in the third month of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. Participants will be randomized in two groups: * Group 1, Regular Clinical Protocol, 17 participants * Group 2, Simplified Clinical Protocol, 17 participants
| Arm | Type | Receives |
|---|---|---|
| Group 1, Regular Protocol | Active comparator | Procedure: Regular Protocol with advanced carbohydrate countingParticipants will bolus (insulin), based on carbohydrate content in each meal |
| Group 2, Simplified protocol | Experimental | Procedure: Simplified Protocol with fixed carbohydrate contentParticipants will bolus (insulin), based on three sets of meal set of meals announcement |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of type 1 diabetes >0.5 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.
- Age 12-18 years and above at the initiation of the system
- 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)
- Clinically able to start the AHCL system
Key exclusion criteria (3 listed)
- Pregnancy
- Untreated diabetes retinopathy, or other causes that in the investigator's opinion , precludes the individual from participating in the trial.
- Currently in other Clinical 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 |
|---|---|---|
| Regular Protocol with advanced carbohydrate counting* Review 3 Days CGM data in Manual Mode * Carb Ratio by formula 360 / TDD * Finetune ICR * Target 100 or 110 mg/dl * AIT: 2-3 hour * Insulin Bolus for meal (advanced carb counting) * The parameters will be set using clinical assessment and fine-tuned if needed on F-up visits. * Follow up visits will be scheduled Day 7, 14,28, 56 and 84 after enabling SmartGuard (AHCL use). | Procedure or surgery | Group 1, Regular Protocol |
| Simplified Protocol with fixed carbohydrate content* Review 3 Days CGM data in Manual Mode * Carb Ratio by formula 360 / TDD ICR 8-10 (TDD 40-60) ICR 5-7 (TDD >60) * Target 100 mg/dl * AIT: 2 hours * Insulin Bolus for meal (Thee sets of meal set of meals announcement carbs will be provided) Regular meal: Total Carbs per Day x 0.6 / 3 Large meal: Total Carbs per Day x 0.6 / 3 x 1.5 Small (Snack) meal: Total Carbs per Day x 0.6 / 3 x 1.5 * Total carbs per day will be calculated as average on 7-days Food Logbook diary, provided by participant, one week before AHCL initiation. * The parameters will be fixed and fine-tuned only in case of hypoglycemia on F-up visits. | Procedure or surgery | Group 2, Simplified protocol |
Primary outcome
Time in Range( 70-180 mg/dl)
Time frame: Third month
Group change in the third month of AHCL use
6 secondary outcomes
HbA1c
Time frame: 3 months
Average Sensor Glucose
Time frame: 3 months
Time Bellow Range (<70 mg/dl, <54 mg/dl)
Time frame: 3 months
Time Above Range (>180 mg/dl)
Time frame: 3 months
Diabetic Ketoacidosis
Time frame: 3 months
Severe Hypoglycemia
Time frame: 3 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 12 Apr 2023.
- Background: PubMed 31876178Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. From Multiple Daily Injections to Hybrid Closed-Loop System in Ten Days, Utilizing a Structured Initiation Protocol. J Diabetes Sci Technol. 2020 May;14(3):689-690. doi: 10.1177/1932296819895509. Epub 2019 Dec 26. No abstract available.
- Results publication: PubMed 33453783Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.
- Results publication: PubMed 33784187Beato-Vibora PI, Gallego-Gamero F, Ambrojo-Lopez A, Gil-Poch E, Martin-Romo I, Arroyo-Diez FJ. Rapid Improvement in Time in Range After the Implementation of an Advanced Hybrid Closed-Loop System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Sep;23(9):609-615. doi: 10.1089/dia.2021.0037. Epub 2021 Apr 20.
- Results publication: PubMed 31264889Lee MH, Vogrin S, Paldus B, Jones HM, Obeyesekere V, Sims C, Wyatt SA, Ward GM, McAuley SA, MacIsaac RJ, Krishnamurthy B, Sundararajan V, Jenkins AJ, O'Neal DN. Glucose Control in Adults with Type 1 Diabetes Using a Medtronic Prototype Enhanced-Hybrid Closed-Loop System: A Feasibility Study. Diabetes Technol Ther. 2019 Sep;21(9):499-506. doi: 10.1089/dia.2019.0120. Epub 2019 Jul 2.
- Results publication: 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 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.
- Derived from this study: PubMed 38377327Petrovski G, Campbell J, Pasha M, Hussain K, Khalifa A, Umer F, Almajaly D, Hamdar M, Heuvel TVD, Edd SN. Twelve-Month Follow-up from a Randomized Controlled Trial of Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents with Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed-Loop System. Diabetes Technol Ther. 2024 Mar;26(S3):76-83. doi: 10.1089/dia.2023.0429.
- Individual participant dataSharing planned: No
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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.
Goran Petrovski, PhD principal investigator
Sidra Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Protocol with advanced carbohydrate counting and Simplified Protocol with fixed carbohydrate content in people with Diabetes type1, 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 5 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 12 Apr 2023. 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?
Time in Range( 70-180 mg/dl) (time frame: Third month). 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 NCT05069727, 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 12 Apr 2023.