Functional Insulin Treatment Research Articles

Metabolic control of type 1 diabetic patients followed at the University Children's Hospital in Berne: Have we reached the goal?

In type 1 diabetes (T1DM), a good metabolic control is important to reduce and/or postpone complications. Guidelines regarding how to achieve this goal are published by the American Diabetes Association (ADA) and the International Society of Paediatric and Adolescence Diabetes (ISPAD). The aims of this study were to determine the current level of metabolic control in T1DM patients on different treatment regimens, followed at the diabetes outpatient unit of the University Children's Hospital Bern, Switzerland, and to compare it with both the reported data from ten years ago (1998) and with the current guidelines of the ADA and ISPAD. This was an observational, cross-sectional study and involved assessment of HbA1c levels as a surrogate marker of the metabolic control in all patients seen during a regular four month interval at our outpatient clinic. A total of 152 patients (88m, 64f) were recorded. 43.4% (n = 66) were conventionally treated (insulin: twice-daily, three-dose treatment), whereas 56.6% (n = 86) were on a multiple injection treatment (e.g. functional insulin treatment and/or insulin pump). Actual overall HbA1c values, expressed as medians (25th/75th centiles), were 7.6% (7.0/8.3) compared to 7.9% (7.3/8.6) in 1998 (p <0.01). In younger, prepubertal children the HbA1c value recorded was 7.4% (6.9/8.1), and 7.7% (7.2/8.5) in adolescents. Interestingly, no significant difference was observed between HbA1c levels of conventionally versus intensively treated patients. With current treatment strategies, glycaemic control of T1DM children and adolescents improved significantly (p <0.01) between 1998 and 2008, although only a minority of the subjects reached the ISPAD goals.

Feasibility of a Mobile Phone–Based Data Service for Functional Insulin Treatment of Type 1 Diabetes Mellitus Patients

BackgroundPatients with type 1 diabetes mellitus (DM1) have to be active participants in their treatment because they are inevitably responsible for their own day-to-day-care. Availability of mobile Internet access is advancing rapidly and mobile phones are now widely available at low cost. Thus, mobile phones have the potential to assist in daily diabetes management and to enable a telemedical interaction between patients and health care professionals.ObjectiveThe aim of the study was to evaluate the feasibility and user acceptance of a mobile phone–based data service to assist DM1 patients on intensive insulin treatment.MethodsA software application called Diab-Memory (based on Java 2 Mobile Edition) has been developed to support patients when entering diabetes-related data with synchronization to the remote database at the monitoring center. The data were then processed to generate statistics and trends, which were provided for the patient and his/her health care professional via a Web portal. The system has been evaluated in the course of a clinical before-after pilot trial. Outcome measures focused on patients’ adherence to the therapy, availability of the monitoring system, and the effects on metabolic status. General user acceptance of the system was evaluated using a questionnaire.ResultsTen patients (four female) with DM1 participated in the trial. Mean age was 36.6 years (± 11.0 years) and prestudy glycated hemoglobin (HbA1c) was 7.9% (± 1.1%). A total of 3850 log-ins were registered during the 3 months of the study. The total number of received datasets was 13003, which equates to an average of 14 transmitted parameters per patient per day. The service was well accepted by the patients (no dropouts), and data transmission via mobile phone was successful on the first attempt in 96.5% of cases. Upon completion of the study, a statistically significant improvement in metabolic control was observed (HbA1c: prestudy 7.9% ± 1.1% versus poststudy 7.5% ± 0.9%;P= .02). While there was a slight decrease in average blood glucose level (prestudy 141.8 mg/dL ± 22.5 mg/dL vs poststudy 141.2 mg/dL ± 23.1 mg/dL;P= .69), the difference was not statistically significant.ConclusionThe results of the clinical pilot trial indicate that this proposed diabetes management system was well accepted by the patients and practical for daily usage. Thus, using the mobile phone as patient terminal seems to provide a ubiquitous, easy-to-use, and cost efficient solution for patient-centered data acquisition in the management of DM1. To confirm the promising results of the pilot trial further research has to be done to study long-term effects on glycemic control and cost-effectiveness.

8004 INVITED Is patient information empowering?

Objective: To investigate short-term and long-term effects of structured outpatient education for Functional Insulin Treatment (FIT: selective insulin dosages for eating, fasting or correcting hyperglycaemia) on perceived control over diabetes and related health beliefs. FIT was thought to influence the perception of self-efficacy in diabetes, in contrast to conventional treatment, based on scheduled, rigid food intake and insulin delivery—it allows flexible eating, provided independent control of glycemia. Methods: Structured, comprehensive, outpatient group training in FIT for selective use of insulin either for eating, fasting or correction included practical “insulin games.” The FIT program focused on everyday criteria for choices of insulin dosages and thus on the patient's ability to execute his/her newly gained flexible treatment to his/her everyday life while preventing acute and late complications. To evaluate effects of FIT on “Perceived Control over Diabetes” and related “Health Beliefs Concerning Diabetes” (Bradley's questionnaires, 1984), a fully randomized short-term controlled Study 1 (four weeks, 32 patients), and long-term uncontrolled pilot Study 2 (three years, 68 patients) were performed. Results: The short-term study revealed that FIT induced the feeling of independence from situational control while self-managing diabetes. In the long-term study, the patients were increasingly freed from the feeling of being under the control of physician and treatment-related restrictions, which—together with higher perceived self-efficacy—contributed to the feeling of “empowerment.” This was associated with high treatment satisfaction and significant improvement of glycemic control. Conclusion: Structured out-patient group training for FIT results in measurable improvement of patients' perceived control over diabetes and self-efficacy.

Les nouvelles insulines : intérêts et inconvénients

Modern insulin treatment, known as “basal-bolus” is based on the physiology of insulin secretion with a permanent basal secretion over the 24 h and a peak of secretion at the time of the meals. The objective of this treatment is obtaining a strict normoglycemia (80 to 120 mg/dl fasting, less than 140 mg/dl postprandial, bringing glycosylated hemoglobin to around 6.5–7%) while minimizing the hypoglycemic risk and ensuring the best possible quality of life. The ideal basal insulin must meet the interprandial insulin needs, to provide stable interprandial blood glucose levels. Hitherto the basal insulin treatment was mainly provided by 2–3 daily NPH- or 1–2 daily ultralente insulin injections. The average duration of action of NPH insulin, 8-16 h, explains the need for multiplying the injections to cover the nyctemer. Its peak of action, 3–4 h after the injection, increases the risk of hypoglycemia at the end of the morning and at night. Insulin ultralente is no more available in France to the profit of analogues of long duration of action aiming at ensuring better glycemic stability (better reproducibility) and improved quality of life. These analogues of insulin are soluble, i. e. they do not require agitation, thus limiting educational time and the risk of error. The time of onset of action of conventional insulin explains the need for carrying out the injection 1/2–3/4 h before the meal to optimize the control of the postprandial blood glucose. This has a non-negligible impact on the quality of life. The long (5–8 h) duration of action of conventional insulin promotes hypoglycemias. Fast analogues of insulin were developed to improve these kinetics characteristics: they have shorter time of onset and shorter duration of action. When associated with a basal insulin treatment, fast-acting insulin, injected right before the meals, authorizes flexible hours of meals. Skipping meals is also possible. A new educational method, called “functional insulin treatment”, makes it possible, amongst other things, to give the keys to the patients using basal-bolus insulin regimen to adjust the amount of fast-acting insulin to variable quantities of glucids at the price of intensive self-monitoring of blood glucose levels.

Psychometric properties of a new instrument for assessment of treatment satisfaction in insulin-requiring diabetic patients, specifically adapted for evaluation of potential advantages of insulin analogs used either for basal, prandial or correctional purposes

Sensitive instruments are needed to assess the effects of minor treatment changes resulting e.g. from a change of an insulin preparation. To assess such small improvements in diabetic patients treated with Functional Insulin Treatment (FIT) targeting on full flexibility of food intake and life style by appropriate choice of insulin dosage for correctional, prandial or basal purposes, we extended the Status (S) version of the DTSQ (Diabetes Treatment Satisfaction Questionnaire; Bradley, 1994) with items measuring specific FIT components of short-acting insulin (Howorka and Bradley, 2000) and recently for the delayed-acting insulin (22-item version). This extended version (DTSQ-S/22/) was investigated in a validation study with 180 patients (age 46+16, diabetes duration 18+11yrs, women 59%, self-measurements 7+1/d, injections 6.3+1.3/d, HbA1c 7.3+1.0%). Cronbach's alpha coefficients were satisfactory for the classical scale /first 8 items/ (alpha=0.85) and for the 22-items extended scale (alpha=0.91). In factor analysis, principal component analysis of 22 items scale yielded 4 factors explaining 62% of the variance: Factor one described the dimension “satisfaction with correctional and prandial (short acting) insulin“ and explained 19% of the variance, factor two the dimension “satisfaction with predictability, stability and understanding of blood glucose course“, explained 16% of variance. Factor three dealt with more general “satisfaction with current treatment, wish-to-continue and satisfaction with convenience and flexibility“ and explained 14% of the variance. Factor four described “satisfaction with hypoglycaemia perception and treatment“ and explained 13% of the variance. Corrected item-total correlations for the new items related to basal replacement were all p<0.01. As an indication of criterion-related validity significant correlations were found between the sum score of the extended instrument and quality of life assessed by ADDQoL. Extended German DTSQ version shows high levels of internal consistency useful for assessment of minor treatment changes.

Limitations of the so-called “intensified” insulin therapy in type 1 diabetes mellitus

Intensive insulin treatment is defined by basal-prandial insulin therapy which tries to reproduce physiological insulin secretion. This requires 3 to 5 injections and self-monitoring of blood glucose 4 to 5 times a day. Patients who accept their disease and the demanding treatment regimen most often achieve HbA1(c) < 7.5%. Severe complications of diabetes can be avoided without increasing the risk of severe hypoglycemia. However, 50% of type 1 diabetic patients do not reach this objective. The reasons are: the disease itself, the diabetic patient, or the physician. Brittle diabetes with severe, repeated episodes of hypoglycemia and inversely persistent postprandial hyperglycemia prevents patients from reaching the ideal glycemic target. More often, the main obstacle is related to psychological problems: difficulties in self-regulation, denial of the disease, or phobia of hypoglycemia with avoidance behavior. Frequently, young women present eating disorders which can explain the poor diabetes control. The physician himself may be implicated in these poor glycemic results by not prescribing the right tools to obtain optimal glycemic control (staying with just two daily injections with premixed insulin) or by assigning glycemic targets inaccessible for the patient, or when an empathic relationship cannot be established between the patient and the physician. Patient empowerment is the key to the success of functional insulin treatment.

Normalization of Pregnancy Outcome in Pregestational Diabetes Through Functional Insulin Treatment and Modular Outpatient Education Adapted for Pregnancy

Howorka, K; Pumprla, J; Gabriel, M; Feiks, A; Schlusche, C; Nowotny, C; Schobert, E; Waldhoer, T; Langer, M

Normalization of pregnancy outcome in pregestational diabetes through functional insulin treatment and modular out‐patient education adapted for pregnancy

To investigate whether modular out-patient group education for flexible, Functional Insulin Treatment (FIT) adapted for pregnancy can eliminate diabetes-associated neonatal complications in pregestational diabetes. Outcome analysis of the modular out-patient group education and FIT based on separate insulin dosages for fasting, eating or correcting hyperglycaemia in 76 consecutive pregnancies (in 20 cases first after conception) of 59 patients with pregestational diabetes (Type 1 diabetes, n = 54). (a) diabetic pregnancies: historical controls; (b) non-diabetic pregnancies: retrospective case-controlled study; (c) population-based data of all Austrian newborns registered within the respective time period. HbA1c of 113 +/- 18% of mean value (= 100%) of non-diabetic, non-pregnant population (103 +/- 14% during the last pregnancy trimester), and self-monitored blood glucose of 5.6 +/- 0.7 mmol/l (5.3 +/- 0.7 mmol/l during the last trimester) was achieved throughout all FIT pregnancies. Severe hypoglycaemia occurred in 14 pregnancies. The gestational age at delivery was 39.2 +/- 1.5 weeks (four cases (5.4%) < 37 weeks) with a birth weight of 3305 +/- 496 g. Four newborns (5.3%) were above the 90th, and nine (11.8%) below the 10th percentile for weight of reference population-based data. Hypoglycaemia was recorded in six newborns (8%). Malformations were found in two infants whose mothers booked for diabetes FIT education only after conception. The caesarean delivery rate was 25%. In comparison with historical diabetic pregnancy controls we demonstrated a reduction in major complications, and compared with non-diabetic women, a lowering of diabetes-related neonatal complication rates to general population levels. Structured, comprehensive, modular out-patient group education promoting self-choice of insulin dose for flexible, normal eating prior to conception normalizes pregnancy outcome in diabetes.

Dealing with ceiling baseline treatment satisfaction level in patients with diabetes under flexible, functional insulin treatment: assessment of improvements in treatment satisfaction with a new insulin analogue.

Even a small improvement in satisfaction with treatment for a chronic disease can be valuable. However, sensitive measurements instruments are needed to assess the effects of treatment changes in patients already well satisfied with baseline treatment. Such instruments were thought to be necessary to deal with ceiling effects in scores of satisfaction with functional insulin treatment (FIT) accommodating full flexibility of food intake and lifestyle in diabetes by manipulation of insulin (FIT; Howorka et al. 2000). The Status(S) version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ, Bradley 1994) was extended with items measuring specific components of FIT and its psychometric properties investigated in a validation study with 171 FIT patients with diabetes. A new Change(C) version of DTSQ extended for FIT was used together with the DTSQ(S) by 52 participants in a subsequent randomised cross-over study involving new fast-acting lispro vs. regular insulin, where treatment satisfaction was the primary outcome variable. Insulin lispro use improved satisfaction (p < or = 0.001) both, on classical and extended versions of DTSQ(S) and (C), despite high baseline levels of satisfaction. However, the DTSQ(C) augmented the effects of lispro (p = 0.0001) apparent on DTSQ(S) scores and revealed significant treatment effects (p < or = 0.01) not significant with DTSQ(S). In parallel, glycaemic control improved with lispro (e.g., HbA1c, p = 0.023). Improved satisfaction with treatment was more apparent with DTSQ(C) than DTSQ(S) in patients who at baseline were at or near ceiling for treatment satisfaction.

Empowering diabetes out-patients with structured education:: Short-term and long-term effects of functional insulin treatment on perceived control over diabetes

Objective: To investigate short-term and long-term effects of structured outpatient education for Functional Insulin Treatment (FIT: selective insulin dosages for eating, fasting or correcting hyperglycaemia) on perceived control over diabetes and related health beliefs. FIT was thought to influence the perception of self-efficacy in diabetes, in contrast to conventional treatment, based on scheduled, rigid food intake and insulin delivery—it allows flexible eating, provided independent control of glycemia. Methods: Structured, comprehensive, outpatient group training in FIT for selective use of insulin either for eating, fasting or correction included practical “insulin games.” The FIT program focused on everyday criteria for choices of insulin dosages and thus on the patient's ability to execute his/her newly gained flexible treatment to his/her everyday life while preventing acute and late complications. To evaluate effects of FIT on “Perceived Control over Diabetes” and related “Health Beliefs Concerning Diabetes” (Bradley's questionnaires, 1984), a fully randomized short-term controlled Study 1 (four weeks, 32 patients), and long-term uncontrolled pilot Study 2 (three years, 68 patients) were performed. Results: The short-term study revealed that FIT induced the feeling of independence from situational control while self-managing diabetes. In the long-term study, the patients were increasingly freed from the feeling of being under the control of physician and treatment-related restrictions, which—together with higher perceived self-efficacy—contributed to the feeling of “empowerment.” This was associated with high treatment satisfaction and significant improvement of glycemic control. Conclusion: Structured out-patient group training for FIT results in measurable improvement of patients' perceived control over diabetes and self-efficacy.

Functional insulin treatment principles, teaching approach and practice

Functional insulin treatment principles, teaching approach and practice

Modular education in diabetes and pregnancy: analysis of results of 58 pregnancies in diabetic patients with functional insulin treatment

Functional insulin treatment based on the patient's education for selective use of insulin for fasting, eating or correction of hyperglycaemia was used between 1985 and 1994 prospectively in 58 pregnancies (in 18 cases after conception) in 47 pregnant diabetic patients. We hypothesised that near-normalisation of glycaemia is possible throughout pregnancy by modular outpatient group education, individual counselling and functional insulin treatment. We wanted to investigate to which degree it might eliminate classical diabetes-associated neonatal complications. To avoid hospitalisation if possible and premature induction of labour, patients were taught both the primary adjustment (immediate correction of hyperglycaemia) and the secondary adjustment of the insulin dosages: correction of individual algorithms for insulin use according to daily insulin consumption and mean blood glucose MBG. A target metabolic control (HbA1c levels in the normal range, MBG < 100 and < 90 mg/dl after the 28th week of gestation respectively) was achieved in the majority of the 58 pregnancies. Severe hypoglycaemia occurred in 12 patients (21%). The gestational age at delivery was 39.0 +/- 1.6 (34-41; in 3 cases only [5%] < 37) weeks with an average birth weight of 3335 +/- 521 (1950-4450) g. The birth weight of only 5 newborn (9%) was above the 90th percentile and no one below the 10th percentile for weight of a comparable population. No cases of respiratory distress were observed. Hypoglycaemia was recorded in only 4 newborn (7%) and was comparable also to that of offsprings in non-diabetic women. Malformations were found in two offsprings whose mothers had presented first for diabetes education after conception, pregnancy being terminated in one case of meningomyelocele. Caesarean section (n = 15; 26%) was primarily due to maternal reasons. Functional insulin treatment prior to conception, modular diabetes group education, specific patient motivation for a near-normal glycaemia throughout pregnancy as well as interdisciplinary care allow pregnancy outcome in diabetic patients similar to that in non-diabetic women and thus the realisation of the 5-year targets of the WHO Declaration of St. Vincent 1989.

Influence of functional insulin treatment on health locus of control — a controlled study

Influence of functional insulin treatment on health locus of control — a controlled study

BOOK REVIEWS: Functional Insulin Treatment by Kinga Howorka

Diabetic MedicineVolume 9, Issue 5 p. 492-492 BOOK REVIEWS: Functional Insulin Treatment by Kinga Howorka J. Hosker, J. Hosker Diabetes Day Centre, Doncaster Royal Infirmary, UKSearch for more papers by this author J. Hosker, J. Hosker Diabetes Day Centre, Doncaster Royal Infirmary, UKSearch for more papers by this author First published: June 1992 https://doi.org/10.1111/j.1464-5491.1992.tb01826.xAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume9, Issue5June 1992Pages 492-492 RelatedInformation