An interventional study of Advanced hybrid closed loop insulin pump and Open Loop Insulin Delivery system in Insulin Pump Therapy, sponsored by King Fahad Medical City. Active, not recruiting at 1 site in Saudi Arabia. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by King Fahad Medical City · Not applicable, Interventional, and Treatment
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.
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.
King Fahad Medical City is the lead sponsor of 22 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with Type 1 Diabetes (T1D) on OLID, who observe Ramadan fasting.
Other: Open Loop Insulin Delivery 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.
Also known as: AHCL
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
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)
Time frame: 30 days (the month of Ramadan)
Plan to share: No
Ran from Feb 2024 to primary completion in Mar 2024, 1 month.
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King Fahad Medical City