Insulin Pump TherapyHybridRamNCT06416202
Closed Loop Pumps vs. Traditional Open Loop Pumps in Managing Blood Glucose Levels in T1DM Patients Fasting in Ramadan.
A study testing Advanced hybrid closed loop insulin pump and Open Loop Insulin Delivery system in people with Insulin Pump Therapy, run by King Fahad Medical City at 1 site in Saudi Arabia.
Trial summary
Our proposed study aims to build upon the existing findings by conducting a first-of-its-kind randomized controlled trial (RCT) that directly compares Advanced Hybrid Closed Loop (AHCL) and open-loop insulin delivery (OLID) systems during Ramadan. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Insulin Pump Therapy
- What is being tested?
- Advanced hybrid closed loop insulin pump and Open Loop Insulin Delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2024to 29 Mar 2025
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 diabetes as per the American Diabetes Association classification for at least 1 year.
- Age 14 to 70.
- OLID therapy for at least 6 months.
- Willingness and ability to adhere to the study protocol.
Who cannot join
- Pregnancy.
- Using medications that affect blood glucose like steroids.
- Patients who are not able to fast for the entire month of Ramadan due to medical or non-medical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Advanced Hybrid Closed Loop (AHCL) Therapy Versus Open-Loop Insulin Delivery (OLID) System in Type 1 Diabetes Management During Ramadan: A Randomized Controlled Trial
Our proposed study aims to build upon the existing findings by conducting a first-of-its-kind randomized controlled trial (RCT) that directly compares Advanced Hybrid Closed Loop (AHCL) and open-loop insulin delivery (OLID) systems during Ramadan. This comparison is crucial for understanding the nuanced benefits and potential limitations of each system in the context of Ramadan fasting, a topic not yet explored in RCT settings. By undertaking this study, we intend to bridge this gap in research, providing valuable insights into the effectiveness of these contrasting insulin delivery methods. The outcomes of this research could significantly inform clinical recommendations for T1DM management during Ramadan, emphasizing the importance of personalized treatment approaches that are aligned with patient needs and technological advancements.
Read the detailed description
A Multi-center, randomized controlled trial will be conducted at King Fahad Medical City and Prince Sultan Military Medical City
Participants were randomly assigned to either the control group (OLID) or one of the intervention groups (AHCL). Stratified randomization will be used according to age (<18 and ≥18 years) and HbA1c (<8.5% and ≥8.5%) to avoid overrepresentation of certain age or glycemic control groups.
All groups will receive comprehensive diabetes education and extensive carbohydrate counting training. Continuous glucose monitoring (CGM) will be conducted using the Guardian 4 sensor or Dexcom G6 for the intervention group depending on the type of pump used. The control group will continue using their current CGM device. Data on glycemic control, hypoglycemic events, and patient satisfaction will be collected before and throughout Ramadan. Additionally, fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control.
The investigators compared between groups in terms of the number of fasting days out of the entire month and the number of days in which participants break their fast due to diabetes-related reasons. Days when female participants do not fast due to their menstrual period will not be counted as days of fasting break for the purposes of this analysis.
Sociodemographic data, laboratory investigations, and relevant clinical data will be collected from the Electronic Health Record (EHR). CGM metrics including Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), Glucose Management Indicator (GMI), and Coefficient of Variation (COV) will be gathered. Fructosamine levels will also be measured to assess the immediate past 2 weeks' glycemic control. A survey for diabetes distress and quality of life will be filled by the participants prior to the study.
The same CGM metrics will be collected. Insulin data including total daily dose (TDD) and percentage of basal insulin and meal boluses will be obtained. Fructosamine levels will be measured again at the end of the study to compare with the baseline measurements. This will provide a detailed assessment of the glycemic control changes specifically during Ramadan. The quality of life and diabetes distress surveys will be refilled at the end of the study. HbA1c levels will also be collected at the end of the study for a comprehensive assessment of the glycemic control during Ramadan.
Statistical Analysis:
The sample size was calculated using the confidence interval method. Statistical analyses will include comparative evaluations of HbA1c levels, hypoglycemia incidence, and patient-reported outcomes. Assuming change in time of range by 12%, power: 80% and alpha error of 5%, sample size was calculated at 25 for each group. However, we are planning to include the maximum patients we could recruit to account for the possible patients drop out.
- Conditions
- Insulin Pump Therapy
- Being tested
- Advanced hybrid closed loop insulin pump, Open Loop Insulin Delivery system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced hybrid closed loop insulin pumpDevice
Also called AHCL
All groups will receive comprehensive diabetes education and extensive carbohydrate counting training. Continuous glucose monitoring (CGM) will be conducted using the Guardian 4 sensor or Dexcom G6 for the intervention group depending on the type of pump used. fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control.
Open Loop Insulin Delivery systemOther
Also called OLID
the control group will continue using their current CGM device. Data on glycemic control, hypoglycemic events, and patient satisfaction will be collected before and throughout Ramadan. Additionally, fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control.
| Study group | Role | What they receive |
|---|---|---|
| Open loop insulin delivery | Other | Patients with Type 1 Diabetes (T1D) on OLID, who observe Ramadan fasting. Receives: Other: Open Loop Insulin Delivery system |
| Advanced Hybrid Closed loop system | Active comparator | AHCL system (Medtronic MiniMed 780G or Tandem T-slim x2 pump). Receives: Device: Advanced hybrid closed loop insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range difference between AHCL and OLID during the 30 days of the month of Ramadan
Time in range on CGM (70-180mg/dL)
Measured: 30 days (the month of Ramadan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Feb 2024
- Primary completion11 Mar 2024
- Study completion29 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Insulin Pump TherapyStudies 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
- A multi-center, randomized controlled trial will be conducted at King Fahad Medical City \& Prince Sultan Military Medical City. The study will involve two intervention groups and one control group: one receiving open-loop insulin delivery (OLID) and the others receiving Advanced Hybrid Closed Loop (AHCL) Therapy. Participants will be randomly assigned to either the control group (OLID) or one of the intervention groups (AHCL). Stratified randomization will be used according to age (\<18 and ≥18 years) and HbA1c (\<8.5% and ≥8.5%) to avoid overrepresentation of certain age or glycemic control groups.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nouf Aboalsamh, King Fahad Medical City
- Investigators
- Mohammed AlMehthel, Consultant, Principal investigator, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416202
- Sponsor's protocol ID
- IRB00010471
- Other IDs
- FWA00018774
- Acronym
- HybridRam
- Status last verified
- Aug 2024
- First submitted
- 16 Apr 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wannes S, Gamal GM, Fredj MB, Al Qusayer D, El Abed S, Sedky Y, Khalil M. Glucose control during Ramadan in a pediatric cohort with type 1 diabetes on MiniMed standard and advanced hybrid closed-loop systems: A pilot study. Diabetes Res Clin Pract. 2023 Sep;203:110867. doi: 10.1016/j.diabres.2023.110867. Epub 2023 Aug 4.
PubMed 37544364Elbarbary NS, Ismail EAR. Glycemic control during Ramadan fasting in adolescents and young adults with type 1 diabetes on MiniMed 780G advanced hybrid closed-loop system: A randomized controlled trial. Diabetes Res Clin Pract. 2022 Sep;191:110045. doi: 10.1016/j.diabres.2022.110045. Epub 2022 Aug 17.
PubMed 35987309Alamoudi R, Alsubaiee M, Alqarni A, Saleh Y, Aljaser S, Salam A, Eledrisi M. Comparison of Insulin Pump Therapy and Multiple Daily Injections Insulin Regimen in Patients with Type 1 Diabetes During Ramadan Fasting. Diabetes Technol Ther. 2017 Jun;19(6):349-354. doi: 10.1089/dia.2016.0418. Epub 2017 Mar 15.
PubMed 28296467Al Awadi FF, Echtay A, Al Arouj M, Sabir Ali S, Shehadeh N, Al Shaikh A, Djaballah K, Dessapt-Baradez C, Omar Abu-Hijleh M, Bennakhi A, El Hassan Gharbi M, El Sayed El Hadidy K, Abdul Kareem Khazaal F, Hassanein MM. Patterns of Diabetes Care Among People with Type 1 Diabetes During Ramadan: An International Prospective Study (DAR-MENA T1DM). Adv Ther. 2020 Apr;37(4):1550-1563. doi: 10.1007/s12325-020-01267-4. Epub 2020 Mar 6.
PubMed 32144714
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Advanced Hybrid Closed Loop (AHCL) Therapy Versus Open-Loop Insulin Delivery (OLID) System in Type 1 Diabetes Management During Ramadan: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06416202
- Acronym / sponsor ID
- HybridRam / IRB00010471
- Conditions
- Insulin Pump Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 29 Mar 2025 (estimated)
- First posted
- 16 May 2024 (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.
Our proposed study aims to build upon the existing findings by conducting a first-of-its-kind randomized controlled trial (RCT) that directly compares Advanced Hybrid Closed Loop (AHCL) and open-loop insulin delivery (OLID) systems during Ramadan. This comparison is crucial for understanding the nuanced benefits and potential limitations of each system in the context of Ramadan fasting, a topic not yet explored in RCT settings. By undertaking this study, we intend to bridge this gap in research, providing valuable insights into the effectiveness of these contrasting insulin delivery methods. The outcomes of this research could significantly inform clinical recommendations for T1DM management during Ramadan, emphasizing the importance of personalized treatment approaches that are aligned with patient needs and technological advancements.
Detailed description
A Multi-center, randomized controlled trial will be conducted at King Fahad Medical City and Prince Sultan Military Medical City
Participants were randomly assigned to either the control group (OLID) or one of the intervention groups (AHCL). Stratified randomization will be used according to age (<18 and ≥18 years) and HbA1c (<8.5% and ≥8.5%) to avoid overrepresentation of certain age or glycemic control groups.
All groups will receive comprehensive diabetes education and extensive carbohydrate counting training. Continuous glucose monitoring (CGM) will be conducted using the Guardian 4 sensor or Dexcom G6 for the intervention group depending on the type of pump used. The control group will continue using their current CGM device. Data on glycemic control, hypoglycemic events, and patient satisfaction will be collected before and throughout Ramadan. Additionally, fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control.
The investigators compared between groups in terms of the number of fasting days out of the entire month and the number of days in which participants break their fast due to diabetes-related reasons. Days when female participants do not fast due to their menstrual period will not be counted as days of fasting break for the purposes of this analysis.
Sociodemographic data, laboratory investigations, and relevant clinical data will be collected from the Electronic Health Record (EHR). CGM metrics including Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), Glucose Management Indicator (GMI), and Coefficient of Variation (COV) will be gathered. Fructosamine levels will also be measured to assess the immediate past 2 weeks' glycemic control. A survey for diabetes distress and quality of life will be filled by the participants prior to the study.
The same CGM metrics will be collected. Insulin data including total daily dose (TDD) and percentage of basal insulin and meal boluses will be obtained. Fructosamine levels will be measured again at the end of the study to compare with the baseline measurements. This will provide a detailed assessment of the glycemic control changes specifically during Ramadan. The quality of life and diabetes distress surveys will be refilled at the end of the study. HbA1c levels will also be collected at the end of the study for a comprehensive assessment of the glycemic control during Ramadan.
Statistical Analysis:
The sample size was calculated using the confidence interval method. Statistical analyses will include comparative evaluations of HbA1c levels, hypoglycemia incidence, and patient-reported outcomes. Assuming change in time of range by 12%, power: 80% and alpha error of 5%, sample size was calculated at 25 for each group. However, we are planning to include the maximum patients we could recruit to account for the possible patients drop out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multi-center, randomized controlled trial will be conducted at King Fahad Medical City \& Prince Sultan Military Medical City. The study will involve two intervention groups and one control group: one receiving open-loop insulin delivery (OLID) and the others receiving Advanced Hybrid Closed Loop (AHCL) Therapy. Participants will be randomly assigned to either the control group (OLID) or one of the intervention groups (AHCL). Stratified randomization will be used according to age (<18 and ≥18 years) and HbA1c (<8.5% and ≥8.5%) to avoid overrepresentation of certain age or glycemic control groups.
| Arm | Type | Receives |
|---|---|---|
| Open loop insulin delivery | Other | Other: Open Loop Insulin Delivery systemPatients with Type 1 Diabetes (T1D) on OLID, who observe Ramadan fasting. |
| Advanced Hybrid Closed loop system | Active comparator | Device: Advanced hybrid closed loop insulin pumpAHCL system (Medtronic MiniMed 780G or Tandem T-slim x2 pump). |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes as per the American Diabetes Association classification for at least 1 year.
- Age 14 to 70.
- OLID therapy for at least 6 months.
- Willingness and ability to adhere to the study protocol.
Key exclusion criteria (3 listed)
- Pregnancy.
- Using medications that affect blood glucose like steroids.
- Patients who are not able to fast for the entire month of Ramadan due to medical or non-medical reasons.
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 insulin pumpAlso: AHCLAll groups will receive comprehensive diabetes education and extensive carbohydrate counting training. Continuous glucose monitoring (CGM) will be conducted using the Guardian 4 sensor or Dexcom G6 for the intervention group depending on the type of pump used. fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control. | Device | Advanced Hybrid Closed loop system |
| Open Loop Insulin Delivery systemAlso: OLIDthe control group will continue using their current CGM device. Data on glycemic control, hypoglycemic events, and patient satisfaction will be collected before and throughout Ramadan. Additionally, fructosamine levels for all patients will be checked both before and after Ramadan to provide a more immediate assessment of glycemic control. | Other | Open loop insulin delivery |
Primary outcome
Time in Range difference between AHCL and OLID during the 30 days of the month of Ramadan
Time frame: 30 days (the month of Ramadan)
Time in range on CGM (70-180mg/dL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 37544364Wannes S, Gamal GM, Fredj MB, Al Qusayer D, El Abed S, Sedky Y, Khalil M. Glucose control during Ramadan in a pediatric cohort with type 1 diabetes on MiniMed standard and advanced hybrid closed-loop systems: A pilot study. Diabetes Res Clin Pract. 2023 Sep;203:110867. doi: 10.1016/j.diabres.2023.110867. Epub 2023 Aug 4.
- Background: PubMed 35987309Elbarbary NS, Ismail EAR. Glycemic control during Ramadan fasting in adolescents and young adults with type 1 diabetes on MiniMed 780G advanced hybrid closed-loop system: A randomized controlled trial. Diabetes Res Clin Pract. 2022 Sep;191:110045. doi: 10.1016/j.diabres.2022.110045. Epub 2022 Aug 17.
- Background: PubMed 28296467Alamoudi R, Alsubaiee M, Alqarni A, Saleh Y, Aljaser S, Salam A, Eledrisi M. Comparison of Insulin Pump Therapy and Multiple Daily Injections Insulin Regimen in Patients with Type 1 Diabetes During Ramadan Fasting. Diabetes Technol Ther. 2017 Jun;19(6):349-354. doi: 10.1089/dia.2016.0418. Epub 2017 Mar 15.
- Background: PubMed 32144714Al Awadi FF, Echtay A, Al Arouj M, Sabir Ali S, Shehadeh N, Al Shaikh A, Djaballah K, Dessapt-Baradez C, Omar Abu-Hijleh M, Bennakhi A, El Hassan Gharbi M, El Sayed El Hadidy K, Abdul Kareem Khazaal F, Hassanein MM. Patterns of Diabetes Care Among People with Type 1 Diabetes During Ramadan: An International Prospective Study (DAR-MENA T1DM). Adv Ther. 2020 Apr;37(4):1550-1563. doi: 10.1007/s12325-020-01267-4. Epub 2020 Mar 6.
- Individual participant dataSharing planned: No
Related trials for Insulin Pump Therapy
RecruitingObservational study
Healthcare Practitioners Knowledge on Diabetes Technology
Diabetes Technology, Continuous Glucose Monitoring System
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.
Mohammed AlMehthel, Consultant principal investigator
King Fahad Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced hybrid closed loop insulin pump and Open Loop Insulin Delivery system in people with Insulin Pump Therapy, run by King Fahad Medical City at 1 site in Saudi Arabia.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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 Saudi Arabia. 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?
Results are not available in the source record.
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 difference between AHCL and OLID during the 30 days of the month of Ramadan (time frame: 30 days (the month of Ramadan)). 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 NCT06416202, which also lists 4 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 14 Aug 2024; AzTrials last refreshed its copy on 27 Oct 2026.