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The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.
Glucose metabolism in patients newly diagnosed with moderate-severe OSA and without diabetes will be monitored for two weeks prior to commencement of CPAP using a CGM. They will consume a 75g oral glucose drink fasted on waking twice during the two-week monitoring period, having consumed a standardised meal the evening prior. After establishing CPAP use for at least four weeks they will undergo the same protocol as for the observation period prior to commencing CPAP. Glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP off condition | No Intervention | Participants will be monitored for a two-week period prior to commencing CPAP. | |
| CPAP on condition | Experimental | Participants will be monitored for a two-week period at least four weeks following commencement of CPAP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | A positive CPAP intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24 hour glucose difference between the CPAP on and CPAP off conditions | Average 24 hour glucose difference between CPAP on and CPAP off conditions | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daytime glucose difference between the CPAP on and CPAP off conditions | Mean Daytime (6:00 AM - 10:00 PM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 weeks |
| Mean night time glucose |
| Measure | Description | Time Frame |
|---|---|---|
| TIR Improvement >10% and <0.5% increase in TBR <3.0 mmol/L | Proportion of participants with >10% improvement in percentage of TIR 3.9-10.0 mmol/L without an increase in the TBR <3.0 mmol/L of >0.5% during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
Inclusion Criteria:
6. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (<3 months) findings:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David J Sherring, MBBS, DClinD | Contact | 0407886698 | dshe7670@uni.sydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Craig L Phillips, PhD | Woolcock Institute of Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
All data will be deidentified using a unique study ID.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Mean Night-time (10:00 PM - 6:00 AM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| 2 weeks |
| Glucose tolerance | Difference in glucose tolerance as measured by peak 2-hour post 75g glucose load administered twice during each two-week observation period using a CGM | 2 weeks |
| Coefficient of Variation | Percentage CV intraday (i.e. within 24h) and interday (i.e. over multiple days) between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| SD of Mean Glucose | SD of Mean Glucose (daily) during the CPAP on and CPAP off conditions during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time in Range (TIR) | Percentage of TIR (3.9-10.0 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time Below Range (TBR) | Percentage of TBR (3.9 mmol/L including readings of <3 .0 mmol/L) during the the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time below Range <3.0 mmol/L | Percentage of TBR <3.0 mmol/L (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time Above Range (TAR) | Percentage of TAR (>10.0 mmol/L, including readings >13.9 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time Above Range >13.9 mmol/L | Percentage of TAR >13.9 mmol/L (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time in Tight Range (TITR) | Percentage of TITR (3.9-7.8 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Change in Glucose Management Indicator | Absolute main change in mmol/L or percentage during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Extended hypoglycaemic event rate | Number of events with sensor glucose <3.9 mmol/L lasting at least 120 min, event ends when glucose returns to at least 3.9 mmol/L for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Extended hyperglycaemic event | Number of events with sensor glucose >13.9 mmol/L lasting at least 120 min; event ends when glucose returns to 10 mmol/L or less for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TIR >70% | Proportion of participants with TIR 3.9-10.0 mmol/L for >70% of the day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TIR improvement at least 5% | Proportion of participants with TIR 3.9-10.0 mmol/L with at least a 5% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TIR improvement at least 10% | Proportion of participants with TIR 3.9-10.0 mmol/L with at least a 10% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TBR <3.9 mmol/L <4% | Proportion of participants with TBR <3.9 mmol/L for <4% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TBR <3.0 mmol/L <1% | Proportion of participants with TBR <3.0 mmol/L for <1% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TAR >10.0 mmol/L >25% | Proportion of participants with a TAR >10.0 mmol/L for <25% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TAR >13.9 mmol/L <5% | Proportion of participants with TAR >13.9 mmol/L for <5% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Hypoglycaemia | Number of times CGM sensor values are <3.9 mmol/L (including readings of <3.0 mmol/L) for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol/L. | 2 Weeks |
| Hypoglycaemia Alert Value (Level 1) | Number of times CGM sensor values are 3.0-3.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol/L. | 2 Weeks |
| Clinically Significant Hypoglycaemia (Level 2) | Number of times CGM sensor values are <3.0 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.0 mmol/L. | 2 Weeks |
| Extended Hypoglycaemia | Number of times CGM sensor values are <3.9 mmol/L for at least 120 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| High Glucose Level (Level 1) | Number of times CGM sensor values are 10.1-13.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 10 mmol/L. | 2 Weeks |
| Very High Glucose (Level 2) | Number of times CGM sensor values are >13.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 13.9 mmol/L. | 2 Weeks |
| Extended Hyperglycaemia | Number of times CGM sensor values are >13.9 mmol/L for at least 90 consecutive minutes within a 120-minute period during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Mean Glucose <8.6 mmol/L and <1% TBR <3.0 mmol/L |
Proportion of participants with Mean Glucose <8.6 mmol/L and < 1% TBR <3.0 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| 2 Weeks |
| TIR >70% and <1% TBR <3.9 mmol/L | Proportion of participants with >70% TIR 3.9-10.0mmol/L and <4% TBR <3.9 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TIR >70% and < 1% TBR <3.0 mmol/L | Proportion of participants with >70% TIR 3.9-10.0 mmol/L and <1% TBR <3.0 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Woolcock Institute of Medical Research | Macquarie Park | New South Wales | 2113 | Australia |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |