Diabetes, Insulin
Conditions
Keywords
insulin, dosage software
Brief summary
The purpose of the study is to determine the effectiveness and safety of the computer software program in providing insulin dosage recommendations. Participation in the study for 60 research subjects will last for 16-weeks and includes 3-4 clinic visits and a series of weekly telephone calls from the study team (minimum of 12 calls). Participants will be provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or drop off a copy of the Study Log Sheet. This information will be entered by the IDC study team into the computer software program. The IDC study team will review the information from the software and, based on the IDC's study team approval, any insulin dose changes will be communicated back to the patient by phone or fax.
Detailed description
Hygieia, Inc. is developing a device intended for use by insulin-requiring patients with diabetes. It will be a pocket-sized, hand-held device, combining a glucose meter with software that analyzes blood glucose levels recorded in the device's memory, and periodically recommends modifications in insulin dosage. The already developed software algorithms are based on the way an endocrinologist evaluates and frequently adjusts insulin dosage in a patient with diabetes.
Interventions
DEVICEinsulin dose software
The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hygieia, Inc
International Diabetes Center at Park Nicollet
HealthPartners Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* GROUP I * Have been clinically diagnosed with type-1 diabetes for at least 1-year * Have an HgbA1c of 7.4% or higher * Treated with short-acting insulin analog (i.e. HumaLog® Lispro, NovoLog® Aspart, Apidra® Glulisine) before each meal and only one injection of long-acting insulin analog Lantus® (Glargine), per day. Subjects must typically eat 3 meals per day. The total daily combined dose of the long-acting and short-acting insulin analogs must be 25 units or more. Patient must have been using the same insulin regimen for the previous 3-months * Is currently using an insulin/carbohydrate ratio to decide how much short-acting insulin to take before meals and must be able to use the gram versus choice method of carbohydrate counting. * GROUP II * Have been clinically diagnosed with type-2 diabetes for at least 1-year * Have an HgbA1c of 7.4% or higher * Treated with short-acting insulin analog (i.e. HumaLog® Lispro, NovoLog® Aspart, Apidra® Glulisine) before each meal and only one injection of long-acting insulin analog Lantus® (Glargine) per day and. Subjects must typically eat 3 meals per day. The total daily combined dose of the long-acting and short-acting insulin analogs must be 25 units or more. Patient must have been using the same insulin regimen for the previous 3-months * May be using other diabetes agent(s) at a stable dose for the last 3-months. * GROUP III * Have been clinically diagnosed with type-2 diabetes for at least 1-year * Have an HgbA1c of 7.8% or higher * Take twice daily biphasic Insulin (e.g. HumaLog® Mix 75/25, NovoLog® Mix 70/30) or premixed insulin (i.e. Humulin® 70/30, Novolin® 70/30, NPH/Regular insulin 70/30) with a total daily insulin dose of 25 units and have been using the same insulin regimen for the past 3-months * May be using other diabetes agent(s) at a stable dose for the last 3-months.
Exclusion criteria
* Have a history of greater than 2 episodes of severe hypoglycemia in the past year, or have hypoglycemic unawareness when glucose levels are less than or equal to 50 mg/dl * Have a significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol * Have any severe cardiovascular disease including a history of congestive heart failure (New York Heart Association \[NYHA\] 3 or 4), unstable angina, myocardial infarction or stroke that occurred within the 6-months preceding enrollment * Have known active anemia with a hemotocrit less than 25% in women or 30% in men * Have known history of renal disease (e.g., serum creatinine level \>2.0 mg/dl or eGFR \< 30 ml/min) * Have active cancer or cancer in the past 2-years (except non-melanoma skin cancer * Have history of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values) * Have a body mass index (BMI) \> 45 kg/m2; and/or * Are pregnant, plan to become pregnant during the study period, or are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Weekly Mean Blood Glucose From Week 4 to Week 16 | Twelve week period from week 4 to week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in HbA1c. | Twelve week period from week 4 to week 16 |
| Reduction in Fructosamine. | 12 week period from Week 4 to Week 16 |
| Incidence of Severe or Serious Hypoglycemia. | January 2011 |
Countries
United States
Participant flow
Recruitment details
July 2010 to October 2010. Location: Medical Clinic
Participants by arm
| Arm | Count |
|---|---|
| Group I Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting | 20 |
| Group II Type 2 diabetes treated with basalbolus therapy | 20 |
| Group III Type 2 diabetes treated with biphasic insulin. | 6 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Group I | Group II | Group III |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 0 Participants | 7 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 20 Participants | 13 Participants | 5 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 12 | 44 years STANDARD_DEVIATION 12 | 60 years STANDARD_DEVIATION 7 | 55 years STANDARD_DEVIATION 7 |
| Fructosamine | 303 µM STANDARD_DEVIATION 53 | 349 µM STANDARD_DEVIATION 46 | 273 µM STANDARD_DEVIATION 30 | 270 µM STANDARD_DEVIATION 33 |
| HbA1c | 8.4 percent STANDARD_DEVIATION 0.8 | 8.4 percent STANDARD_DEVIATION 0.6 | 8.3 percent STANDARD_DEVIATION 0.8 | 9.1 percent STANDARD_DEVIATION 1.5 |
| Region of Enrollment United States | 46 participants | 20 participants | 20 participants | 6 participants |
| Sex: Female, Male Female | 27 Participants | 13 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 19 Participants | 7 Participants | 10 Participants | 2 Participants |
| Weekly Mean Blood Glucose | 172.4 mg/dL STANDARD_DEVIATION 35 | 176.9 mg/dL STANDARD_DEVIATION 28.3 | 164.9 mg/dL STANDARD_DEVIATION 37.6 | 190.8 mg/dL STANDARD_DEVIATION 47 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 6 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 6 |
Outcome results
Primary
Change in Weekly Mean Blood Glucose From Week 4 to Week 16
Time frame: Twelve week period from week 4 to week 16
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I | Change in Weekly Mean Blood Glucose From Week 4 to Week 16 | 4.6 mg/dL | Standard Deviation 29.3 |
| Group II | Change in Weekly Mean Blood Glucose From Week 4 to Week 16 | 8.1 mg/dL | Standard Deviation 51 |
| Group III | Change in Weekly Mean Blood Glucose From Week 4 to Week 16 | 29.5 mg/dL | Standard Deviation 17.1 |
Secondary
Incidence of Severe or Serious Hypoglycemia.
Time frame: January 2011
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group I | Incidence of Severe or Serious Hypoglycemia. | 0 Participants |
| Group II | Incidence of Severe or Serious Hypoglycemia. | 0 Participants |
| Group III | Incidence of Severe or Serious Hypoglycemia. | 0 Participants |
Secondary
Reduction in Fructosamine.
Time frame: 12 week period from Week 4 to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I | Reduction in Fructosamine. | -4.2 µM | Standard Deviation 29.2 |
| Group II | Reduction in Fructosamine. | 10.2 µM | Standard Deviation 32.2 |
| Group III | Reduction in Fructosamine. | 37.0 µM | Standard Deviation 20.9 |
Secondary
Reduction in HbA1c.
Time frame: Twelve week period from week 4 to week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I | Reduction in HbA1c. | 0.1 percentage of A1c | Standard Deviation 0.8 |
| Group II | Reduction in HbA1c. | 0.6 percentage of A1c | Standard Deviation 0.9 |
| Group III | Reduction in HbA1c. | 1.3 percentage of A1c | Standard Deviation 1.4 |