Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-16
Brief Title:
Closed Loop Pumps vs Traditional Open Loop Pumps in Managing Blood Glucose Levels in T1DM Patients Fasting in Ramadan
Sponsor:
King Fahad Medical City
Organization:
King Fahad Medical City
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HybridRam
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
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 85 and 85 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
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 85 and 85 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FWA00018774 | OTHER | Federal Wide Assurance NlH US | None |