Glycaemic control and prevention of hypoglycaemia in intensively treated subjects with type 1 diabetes using Accu-Chek® advisor insulin guidance software

INTERVENTION: The primary outcome of this study was predefined as a reduction in HbA1c value of more than 0.4% in the experimental group. Subjects randomised to the experimental group received a Personal Digital Assistant (PDA) loaded with the insulin guidance software. At baseline (visit 1), a healthcare provider and/or Certified Diabetes Educator (CDE) reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The software program allowed the healthcare provider to enter demographic data such as age, height and weight which could potentially affect the insulin sensitivity factor already programmed into the device. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for Self Monitored Blood Glucose (SMBG) testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event. All the data from the glucose meters and the PDAs were downloaded at every visit. Glucose values were captured in one of the following categories to assess target glycaemia and pie charts were created. Within Target Range (WTR) glucose values were those between 70 ‐ 150 mg/dL (3.89 to 8.33 mmol/L). Below Target Range (BTR) glucose values were defined as 69 mg/dL (3.83 mmol/L) and Above Target Range (ATR) glucose values were those values above 150 mg/dL (8.33 mmol/L). These glucose levels were chosen based on our previous research on SMBG downloads. Hypoglycaemia: Hypoglycaemia was defined as glucose values of 59 mg/dL (3.27 mmol/L). Severe hypoglycaemia was defined as subjects needi CONDITION: Type 1 Diabetes ; Nutritional, Metabolic, Endocrine ; Diabetes PRIMARY OUTCOME: Improvement in glucose control by at least 0.4% reduction in HbA1c values in subjects using insulin guidance software at 6 months and 1 year. SECONDARY OUTCOME: Secondary outcomes were measured at each of the clinic visits given below for:; 1. Hypoglycaemia; 2. Weight gain; 3. Insulin dose; 4. Frequency of self monitoring of blood glucose, within, above and below the target range glycaemia (70 ‐ 150 mg/dL); ; All subjects were asked to attend seven in‐clinic visits (baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months) and participate in three telephone visits (4.5 months, 7.5 months, 9.5 months) throughout the course of the study. Data for blood glucose values, testing frequency, hyperglycaemic excursions, hypoglycaemic events (all, nocturnal, and severe), insulin dose, weight and BMI, hospitalisations, emergency room visits and illnesses were recorded at each in clinic visit. All subjects completed a patient satisfaction questionnaire and the experimental group also completed an Advisor questionnaire. ; ; As part of their routine clinical care, any additional phone visits were equally encouraged in both groups. INCLUSION CRITERIA: 1. Adult ‐ male or female, 18 to 60 years of age 2. Diagnosed with Type 1 diabetes mellitus at least six months 3. HbA1c greater than 7.5% and less than 11.0% at screening 4. Insulin dose 0.5 ‐ 2.0 units/kg 5. Hematocrit between 25% and 65% 6. Weight 100 ‐ 300 pounds 7. On a dual insulin therapy supported by Accu‐Chek® insulin advisor software 8. On a "day shift" schedule (typical day begins before noon) 9. Willing to perform a minimum of three blood glucose tests per day ‐ before breakfast, before lunch, and before dinner (standard of care) 10. Willing to complete at least 7 clinic visits in 12 months (baseline, 2‐week, 6‐week, 3‐month, 6‐month, 9‐month, and 12‐month) 11. Willing to complete three study phone calls conducted by study coordinator (4.5‐month, 7.5‐month and 10.5‐month) 12. Able and willing to provide written informed consent to participate 13. Willing to comply with the study protocol 14. Willing to be randomis