Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Insulin Pump, Continuous Glucose Monitor, Exercise, Glucose Variability, Decision Support System, Multiple Daily Injections (MDI)
Brief summary
The purpose of this study is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump.
Detailed description
The overall aim of this proposed research is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump. The system will be deployed on our portable medical application platform (DiAs) and will include insulin pump treatment parameters optimization and an exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment. A second phase of the trial will enroll additional users of insulin pumps, and subjects who treat their T1DM with the use of multiple daily injections (MDI) of insulin. MDI users should be administering the Lantus (glargine) dose at approximately the same time each day and use only one basal rate per day. MDI users will also use MySugr app to count carbohydrates for all meals that require insulin treatment.
Interventions
DEVICEDecision Support System
The purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing glucose variability in T1DM patient using an insulin pump or MDI. The system will be deployed on our portable medical application platform (DiAs) and will include the following elements: 1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data 2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment. 3. A smart bolus calculator based on CGM glucose measurements and insulin sensitivity estimation.
OTHERUsual Care
During the Control study admission, DiAs will be programmed with the home insulin dosing parameters. The study subject will use the home basal/bolus MDI or continuous subcutaneous insulin infusion (CSII) insulin regimen via the home insulin pens or pump and determine the amount of insulin to give for the entire admission per the subject's home carb counting parameters and as calculated by the DiAs meal screen.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Daniel Chernavvsky, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis based on investigator assessment, of type 1 diabetes for at least one year and either using insulin pump therapy for at least 6 months or MDI therapy (consisting of a of Lantus \[glargine\], Tresiba \[degludec\], or Levemir \[Detemir\] plus rapid-acting meal insulin) for at least 6 months; 1-2 basal insulin injections per day, consistent in timing and amount. A. Historical criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL. ii. Two-hour oral glucose tolerance test (OGTT) glucose ≥200 mg/dL. iii. Hemoglobin A1c ≥6.5% documented. iv. Random glucose ≥200 mg/dL with symptoms. v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes. B. Historical criteria for requiring insulin at diagnosis (1 must be met): i. Participant required insulin at diagnosis and continually thereafter. ii. Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually. iii. Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually. 2. Age 21- 65years old. 3. Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. 4. Demonstration of proper mental status and cognition for the study 5. MDI subjects should be administering the Lantus (glargine), Tresiba \[degludec\], or Levemir \[Detemir\] dose at approximately the same time each day. 6. CSII subjects must currently be using the bolus calculator function of the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. 7. MDI users must currently be using Intensive Insulin Therapy including carbohydrate counting and use of pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor. 8. Willing to use Humalog (lispro) or Novolog (aspart) insulin during the study procedures for MDI subjects. 9. CSII subjects must be willing to use the current bolus calculator pump parameters and enter all carbohydrate intake into the pump during the 28 day data collection period. 10. MDI users must be willing to use their carbohydrate counting parameters for all meal dosing and enter the information into the MySugr app. 11. Ability to access the Internet to provide data to the clinical team or to travel to the research center so that the study equipment and personal pump can be downloaded. 12. An understanding of and willingness to follow the protocol and sign the informed consent.
Exclusion criteria
The presence of any of the following is an exclusion for the study: 1. Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment. 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment. 3. Current treatment of a seizure disorder. 4. Coronary artery disease or heart failure, unless written clearance is received from a cardiologist. 5. Atrial or ventricular arrhythmias (benign premature atrial contractions \[PACs\] and premature ventricular contractions \[PVCs\] allowed) 6. Cystic fibrosis. 7. Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures. 8. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: i. Inpatient psychiatric treatment in the past 6 months ii. Presence of a known adrenal disorder iii. Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function iv. Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty v. Active gastroparesis vi. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study vii. Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise viii. Abuse of alcohol or recreational drugs ix. Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection). x. Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg). xi. Oral steroids xii. Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy) in the past 12 months. 9. A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol. 10. Basal Rates \<0.01 units/hour for CSII subjects. 11. More than one basal dose per day for MDI subjects 12. Allergy for or intolerance of both Novolog (aspart) and Humalog (lispro) insulin for MDI subjects. 13. Diagnosed food allergies. 14. Current use of the following drugs and supplements: i. Regular acetaminophen user, or not willing to suspend acetaminophen 24 hours before and during the entire length of the trial ii. Any other medication that the investigator believes is a contraindication to the subject's participation 15. Any reason for which the study MD considers the subject not properly fitted for the trial (i.e. insulin pump that does not record what is needed for the trial). 16. Current enrollment in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Variability (Coefficient of Variation) | Duration of the 48 hour study admission | Assess effectiveness of glucose variability (GV) advisory system in reducing glucose variability in T1DM patient using an insulin pump. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Below 50 mg/dL | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome. |
| Percent Below 60 mg/dL | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome. |
| Percent Below 70 mg/dL | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome. |
| Percent Between 70 and 180 mg/dL | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | CGM measured blood sugar values between 70 abd 180 mg/dL are considered to be desirable. A higher percentage of time in this range is indicative of a desirable outcome. |
| Percent Above 180 mg/dL | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome |
| Low Blood Glucose Index (LBGI) | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am). | Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM (Insulin dependent diabetes mellitus): validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998) |
| Percent Above 300 mg/dL | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome |
| Average Glycemia (mg/dL) | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | Average glycemia is a measure of the average CGM value in mg/dL during the 48 hour study admission. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome. |
| Total Insulin Used | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | This measure is an average of the total amount of insulin (both basal and bolus) used by participants during the study admission. |
| Basal Insulin Used | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | This measure is an average of the total amount of basal insulin used by participants during the study admission. |
| Total Rescue Carbohydrates (CHO) (Grams) | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | The average of the total amount of rescue carbohydrates (grams) administered during the study admission under safety protocols. Administering fewer carbohydrates is a desirable outcome because it indicates better control. |
| Percent Above 250 mg/dL | 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise). | CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome |
Countries
United States
Participant flow
Recruitment details
Thirty-three subjects started the study. Nine discontinued after starting the study intervention: (1) data collection issues,(1) insulin parameter change needed, (5) personal reasons, and two subjects met stopping criteria - (1) glucagon & (1) high ketones; 24 subjects completed the protocol.
Pre-assignment details
Blinded continuous glucose monitor (CGM) data will be collected for \ 28 days prior to the Experimental Admission and analyzed by the study team to determine the optimal insulin therapy parameters for each insulin pump and multiple daily injections (MDI) participant. These optimized parameters will be used during the \ 48 hour Experimental Admission.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Baseline characteristics of all study participants regardless of randomization. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Invention | Changed parameters during trial | 1 | 0 |
| First Invention | Data collection issues | 1 | 0 |
| First Invention | Stopping criteria | 0 | 1 |
| First Invention | Withdrawal by Subject | 3 | 1 |
| Second Intervention | Stopping Criteria | 1 | 0 |
| Second Intervention | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 11 |
| Body Mass Index (BMI), kg/m2 | 27.4 kg/m^2 STANDARD_DEVIATION 4.6 |
| Height | 172 cm STANDARD_DEVIATION 10.7 |
| Hemoglobin A1c (HbA1c) | 7.2 percentage STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 9 Participants |
| Total Daily Insulin (TDI) | 46.7 U STANDARD_DEVIATION 22.3 |
| Type 1 Diabetes Mellitus (T1DM) duration | 21 years STANDARD_DEVIATION 11.1 |
| Weight | 81.8 kg STANDARD_DEVIATION 19.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 1 / 33 | 1 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Glucose Variability (Coefficient of Variation)
Assess effectiveness of glucose variability (GV) advisory system in reducing glucose variability in T1DM patient using an insulin pump.
Time frame: Duration of the 48 hour study admission
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Support System | Glucose Variability (Coefficient of Variation) | Overall | 0.33 coefficient of variation | Standard Deviation 0.06 |
| Decision Support System | Glucose Variability (Coefficient of Variation) | Mealtime (4h following lunch and dinner) | 0.3 coefficient of variation | Standard Deviation 0.07 |
| Decision Support System | Glucose Variability (Coefficient of Variation) | Overnight (11 pm-7 am) | 0.25 coefficient of variation | Standard Deviation 0.08 |
| Usual Care (Control) | Glucose Variability (Coefficient of Variation) | Overall | 0.36 coefficient of variation | Standard Deviation 0.08 |
| Usual Care (Control) | Glucose Variability (Coefficient of Variation) | Mealtime (4h following lunch and dinner) | 0.34 coefficient of variation | Standard Deviation 0.09 |
| Usual Care (Control) | Glucose Variability (Coefficient of Variation) | Overnight (11 pm-7 am) | 0.28 coefficient of variation | Standard Deviation 0.1 |
Comparison: Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.045ANOVA
Comparison: Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.07ANOVA
Comparison: Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.177ANOVA
Secondary
Average Glycemia (mg/dL)
Average glycemia is a measure of the average CGM value in mg/dL during the 48 hour study admission. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Support System | Average Glycemia (mg/dL) | Overall | 155.2 mg/dL | Standard Deviation 23.2 |
| Decision Support System | Average Glycemia (mg/dL) | Mealtime | 142.7 mg/dL | Standard Deviation 29.7 |
| Decision Support System | Average Glycemia (mg/dL) | Overnight | 151.9 mg/dL | Standard Deviation 29.9 |
| Usual Care (Control) | Average Glycemia (mg/dL) | Overnight | 156.9 mg/dL | Standard Deviation 37.6 |
| Usual Care (Control) | Average Glycemia (mg/dL) | Overall | 155.2 mg/dL | Standard Deviation 27.1 |
| Usual Care (Control) | Average Glycemia (mg/dL) | Mealtime | 144 mg/dL | Standard Deviation 35.5 |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.86ANOVA
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.522ANOVA
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.522ANOVA
Secondary
Basal Insulin Used
This measure is an average of the total amount of basal insulin used by participants during the study admission.
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support System | Basal Insulin Used | 20.3 U | Standard Deviation 9.1 |
| Usual Care (Control) | Basal Insulin Used | 21.4 U | Standard Deviation 11.1 |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.189ANOVA
Secondary
Low Blood Glucose Index (LBGI)
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM (Insulin dependent diabetes mellitus): validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Support System | Low Blood Glucose Index (LBGI) | Overall | 1.59 LBGI | Standard Deviation 1.27 |
| Decision Support System | Low Blood Glucose Index (LBGI) | Overnight | 1.89 LBGI | Standard Deviation 1.83 |
| Usual Care (Control) | Low Blood Glucose Index (LBGI) | Overall | 2.49 LBGI | Standard Deviation 2.08 |
| Usual Care (Control) | Low Blood Glucose Index (LBGI) | Overnight | 2.18 LBGI | Standard Deviation 1.96 |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test was used. Data were first binned (to ensure minimum count of five per bins) \& w2 statistics was used with expected counts given by standard of care. Based on achieved recruitment, moderate effect size (0.3) was detectable with 80% power, or large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.042ANOVA
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.276ANOVA
Secondary
Percent Above 180 mg/dL
CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Support System | Percent Above 180 mg/dL | Overall | 29.4 percentage of time | Standard Deviation 15.6 |
| Decision Support System | Percent Above 180 mg/dL | Mealtime | 19.9 percentage of time | Standard Deviation 20.4 |
| Decision Support System | Percent Above 180 mg/dL | Overnight | 29.2 percentage of time | Standard Deviation 21.7 |
| Usual Care (Control) | Percent Above 180 mg/dL | Overall | 30.3 percentage of time | Standard Deviation 19.5 |
| Usual Care (Control) | Percent Above 180 mg/dL | Mealtime | 23.6 percentage of time | Standard Deviation 27.9 |
| Usual Care (Control) | Percent Above 180 mg/dL | Overnight | 31.2 percentage of time | Standard Deviation 25 |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.863ANOVA
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.965ANOVA
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.742ANOVA
Secondary
Percent Above 250 mg/dL
CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Decision Support System | Percent Above 250 mg/dL | Overall | 5.2 percentage of time |
| Decision Support System | Percent Above 250 mg/dL | Mealtime | 0 percentage of time |
| Decision Support System | Percent Above 250 mg/dL | Overnight | 0 percentage of time |
| Usual Care (Control) | Percent Above 250 mg/dL | Overall | 6.3 percentage of time |
| Usual Care (Control) | Percent Above 250 mg/dL | Mealtime | 0 percentage of time |
| Usual Care (Control) | Percent Above 250 mg/dL | Overnight | 7.4 percentage of time |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.158Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.085Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.055Wilcoxon (Mann-Whitney)
Secondary
Percent Above 300 mg/dL
CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Decision Support System | Percent Above 300 mg/dL | Overall | 0 percentage of time |
| Decision Support System | Percent Above 300 mg/dL | Mealtime | 0 percentage of time |
| Decision Support System | Percent Above 300 mg/dL | Overnight | 0 percentage of time |
| Usual Care (Control) | Percent Above 300 mg/dL | Overall | 1 percentage of time |
| Usual Care (Control) | Percent Above 300 mg/dL | Mealtime | 0 percentage of time |
| Usual Care (Control) | Percent Above 300 mg/dL | Overnight | 0 percentage of time |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.744Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.248Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.225Wilcoxon (Mann-Whitney)
Secondary
Percent Below 50 mg/dL
CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Decision Support System | Percent Below 50 mg/dL | Overall | 0 percentage of time |
| Decision Support System | Percent Below 50 mg/dL | Mealtime | 0 percentage of time |
| Decision Support System | Percent Below 50 mg/dL | Overnight | 0 percentage of time |
| Usual Care (Control) | Percent Below 50 mg/dL | Overall | 0 percentage of time |
| Usual Care (Control) | Percent Below 50 mg/dL | Mealtime | 0 percentage of time |
| Usual Care (Control) | Percent Below 50 mg/dL | Overnight | 0 percentage of time |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.026Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.173Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.715Wilcoxon (Mann-Whitney)
Secondary
Percent Below 60 mg/dL
CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Decision Support System | Percent Below 60 mg/dL | Overall | 0.1 percentage of time |
| Decision Support System | Percent Below 60 mg/dL | Mealtime | 0 percentage of time |
| Decision Support System | Percent Below 60 mg/dL | Overnight | 0 percentage of time |
| Usual Care (Control) | Percent Below 60 mg/dL | Overall | 0.66 percentage of time |
| Usual Care (Control) | Percent Below 60 mg/dL | Mealtime | 0 percentage of time |
| Usual Care (Control) | Percent Below 60 mg/dL | Overnight | 0 percentage of time |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.036Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.213Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
Percent Below 70 mg/dL
CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Decision Support System | Percent Below 70 mg/dL | Overall | 0.88 percentage of time |
| Decision Support System | Percent Below 70 mg/dL | Mealtime | 1.23 percentage of time |
| Decision Support System | Percent Below 70 mg/dL | Overnight | 1.15 percentage of time |
| Usual Care (Control) | Percent Below 70 mg/dL | Overall | 3.21 percentage of time |
| Usual Care (Control) | Percent Below 70 mg/dL | Mealtime | 1.73 percentage of time |
| Usual Care (Control) | Percent Below 70 mg/dL | Overnight | 3.33 percentage of time |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.018Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.149Wilcoxon (Mann-Whitney)
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.109Wilcoxon (Mann-Whitney)
Secondary
Percent Between 70 and 180 mg/dL
CGM measured blood sugar values between 70 abd 180 mg/dL are considered to be desirable. A higher percentage of time in this range is indicative of a desirable outcome.
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Support System | Percent Between 70 and 180 mg/dL | Overall | 68.9 percentage of time | Standard Deviation 14.3 |
| Decision Support System | Percent Between 70 and 180 mg/dL | Mealtime | 77.9 percentage of time | Standard Deviation 19.2 |
| Decision Support System | Percent Between 70 and 180 mg/dL | Overnight | 68.2 percentage of time | Standard Deviation 20.3 |
| Usual Care (Control) | Percent Between 70 and 180 mg/dL | Overall | 65.9 percentage of time | Standard Deviation 18.6 |
| Usual Care (Control) | Percent Between 70 and 180 mg/dL | Mealtime | 73.3 percentage of time | Standard Deviation 27.3 |
| Usual Care (Control) | Percent Between 70 and 180 mg/dL | Overnight | 63 percentage of time | Standard Deviation 23.5 |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.78ANOVA
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.p-value: 0.399ANOVA
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.p-value: 0.824ANOVA
Secondary
Total Insulin Used
This measure is an average of the total amount of insulin (both basal and bolus) used by participants during the study admission.
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support System | Total Insulin Used | 44.1 U | Standard Deviation 18.4 |
| Usual Care (Control) | Total Insulin Used | 45.5 U | Standard Deviation 22.8 |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.301ANOVA
Secondary
Total Rescue Carbohydrates (CHO) (Grams)
The average of the total amount of rescue carbohydrates (grams) administered during the study admission under safety protocols. Administering fewer carbohydrates is a desirable outcome because it indicates better control.
Time frame: 48 hour study admission, outcomes were further divided into segments of the day: overnight (11 pm- 7 am), and around meals (the 4 h following lunch and dinner, breakfast excluded due to exercise).
Population: 24 participants completed the study. Data from subjects who withdrew were removed from analysis regardless of the degree of protocol completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support System | Total Rescue Carbohydrates (CHO) (Grams) | 81 g | Standard Deviation 74.2 |
| Usual Care (Control) | Total Rescue Carbohydrates (CHO) (Grams) | 96 g | Standard Deviation 78.1 |
Comparison: Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.p-value: 0.271ANOVA