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

May 16, 2024 updated by: Nouf Aboalsamh, King Fahad Medical City

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Riyadh Province
      • Riyadh, Riyadh Province, Saudi Arabia, 11525
        • King Fahad Medical City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open loop insulin delivery
Patients with Type 1 Diabetes (T1D) on OLID, who observe Ramadan fasting.
Other: Open Loop Insulin Delivery system
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.
Other Names:
  • OLID
Active Comparator: Advanced Hybrid Closed loop system
AHCL system (Medtronic MiniMed 780G or Tandem T-slim x2 pump).
Device: Advanced hybrid closed loop insulin pump
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.
Other Names:
  • AHCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies of Hypoglycemic and Hyperglycemic events during Ramadan fasting in individuals with type 1 diabetes who use AHCL to control their blood glucose levels compared to those using conventional OLID methods.
Time Frame: From enrollment to the end of treatment at 12 weeks
Assessment of the effectiveness and safety of Insulin Pump Therapy with AHCL vs OLID during fasting in terms of Time below range(glucose level <50mg/dL) in percentage or Time above range in percent (glucose level >180 mg/dL) and Time in range (75-180mg/dL) on CGM
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Fahad Medical City

Investigators

  • Principal Investigator: Mohammed AlMehthel, Consultant, King Fahad Medical City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

March 11, 2024

Study Completion (Estimated)

June 29, 2024

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00010471
  • FWA00018774 (Other Identifier: Federal Wide Assurance NlH, US)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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