Closed Loop Pumps vs. Traditional Open Loop Pumps in Managing Blood Glucose Levels in T1DM Patients Fasting in Ramadan.

NCT06416202 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: IRB00010471FWA00018774
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Insulin Pump Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days (the month of Ramadan)

Study Arms (2)

Open loop insulin delivery

OTHER

Patients with Type 1 Diabetes (T1D) on OLID, who observe Ramadan fasting.

Other: Open Loop Insulin Delivery system

Advanced Hybrid Closed loop system

ACTIVE COMPARATOR

AHCL system (Medtronic MiniMed 780G or Tandem T-slim x2 pump).

Device: Advanced hybrid closed loop insulin pump

Interventions

Advanced hybrid closed loop insulin pump DEVICE

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.

Also known as: AHCL

Advanced Hybrid Closed loop system

Open Loop Insulin Delivery system OTHER

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.

Also known as: OLID

Open loop insulin delivery

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Fahad Medical City: lead

Study Sites (1)

King Fahad Medical City

Riyadh, Riyadh Region, 11525, Saudi Arabia

Location

Related Publications (4)

• 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.

  PMID: 37544364 BACKGROUND

• Elbarbary 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.

  PMID: 35987309 BACKGROUND

• Alamoudi 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.

  PMID: 28296467 BACKGROUND

• Al 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.

  PMID: 32144714 BACKGROUND

Study Officials

• Mohammed AlMehthel, Consultant

  King Fahad Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 16, 2024
• Study Start: February 1, 2024
• Primary Completion: March 11, 2024
• Study Completion: March 29, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)